Title 9—Animals and Animal Products

(This book contains part 200 to end)

Part CHAPTER II—Grain Inspection, Packers and Stockyards Ad- ministration (Packers and Stockyards Programs), De- partment of Agriculture ...... 201

CHAPTER III—Food Safety and Inspection Service, Meat and Poultry Inspection, Department of Agriculture ...... 301

EDITORIAL NOTE: Other regulations issued by the Department of Agriculture appear in title 7, title 36, chapter II, and title 41, chapter 4.

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Part Page 200 [Reserved] 201 Regulations under the Packers and Stockyards Act 5 202 Rules of practice governing proceedings under the Packers and Stockyards Act ...... 29 203 Statements of general policy under the Packers and Stockyards Act ...... 48 204 Organization and functions ...... 58 205 Clear title—protection for purchasers of farm products ...... 63

EDITORIAL NOTE: Nomenclature changes to Chapter II appear at 60 FR 8465, Feb. 14, 1995.

VerDate 14-MAR-97 14:10 Apr 01, 1997 Jkt 174024 PO 00000 Frm 00003 Fmt 8008 Sfmt 8008 E:\CFR\174024.001 174024 VerDate 14-MAR-97 14:10 Apr 01, 1997 Jkt 174024 PO 00000 Frm 00004 Fmt 8008 Sfmt 8008 E:\CFR\174024.001 174024 PART 200 [RESERVED] 201.49 Requirements regarding scale tickets evidencing weighing of livestock and live poultry. PART 201—REGULATIONS UNDER THE PACKERS AND STOCKYARDS TRADE PRACTICES ACT 201.53 Persons subject to the Act not to circulate misleading reports about market DEFINITIONS conditions or prices. 201.55 Purchases, sales, acquisitions, and Sec. settlements to be made on actual 201.1 Meaning of words. weights. 201.2 Terms defined. 201.56 Market agencies selling on commission; purchases from consignment. ADMINISTRATION 201.61 Market agencies selling or purchasing 201.3 Authority. livestock on commission; relationships with dealers. APPLICABILITY OF INDUSTRY RULES 201.67 Packers not to own or finance selling 201.4 Bylaws, rules and regulations, and re- agencies. quirements of exchanges, associations, or 201.69 Furnishing information to competi- other organizations; applicability, estab- tor buyers. lishment. 201.70 Restriction or limitation of competition between packers and dealers prohib- REGISTRATION ited. 201.10 Requirements and procedures. SERVICES 201.11 Suspended registrants; officers, agents, and employees. 201.71 Scales; accurate weights, repairs, adjustments or replacements after inspec- SCHEDULES OF RATES AND CHARGES tion. 201.17 Requirements for filing tariffs. 201.72 Scales; testing of. 201.73 Scale operators to be qualified. GENERAL BONDING PROVISIONS 201.73–1 Instructions for weighing livestock. 201.27 Underwriter; equivalent in lieu of 201.76 Reweighing. bonds; standard forms. 201.81 Suspended registrants. 201.28 Duplicates of bonds or equivalents to 201.82 Care and promptness in weighing and be filed with Regional Supervisors. handling livestock and live poultry.

MARKET AGENCY, DEALER AND PACKER BONDS INSPECTION OF BRANDS 201.29 Market agencies, packers and dealers 201.86 Brand inspection: Application for au- required to file and maintain bonds. thorization, registration and filing of 201.30 Amount of market agency, dealer and schedules, reciprocal arrangements, and packer bonds. maintenance of identity of consign- 201.31 Conditions in market agency, dealer ments. and packer bonds. GENERAL 201.32 Trustee in market agency, dealer and packer bonds. 201.94 Information as to business; furnish- 201.33 Persons damaged may maintain suit; ing of by packers, live poultry dealers, filing and notification of claims; time stockyard owners, market agencies, and limitations; legal expenses. dealers. 201.34 Termination of market agency, deal- 201.95 Inspection of business records and fa- er and packer bonds. cilities. 201.96 Unauthorized disclosure of business PROCEEDS OF SALE information prohibited. 201.39 Payment to be made to consignor or 201.97 Annual reports. shipper by market agencies; exceptions. 201.98 Packers and dealers not to charge, 201.42 Custodial accounts for trust funds. demand, or collect commission, yardage, or other service charges. ACCOUNTS AND RECORDS 201.99 Purchase of livestock by packers on a 201.43 Payment and accounting for live- carcass grade, carcass weight, or carcass stock and live poultry. grade and weight basis. 201.44 Market agencies to render prompt ac- POULTRY—PACKERS AND LIVE POULTRY counting for purchases on order. DEALERS 201.45 Market agencies to make records available for inspection by owners, con- 201.100 Records to be furnished poultry signors, and purchasers. growers and sellers.

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201.108–1 Instructions for weighing live the Act and the regulations in this poultry. part. 201.200 Sale of livestock to a packer on credit. (i) Stockyard means a livestock market which has received notice under AUTHORITY: 7 U.S.C. 204, 228, 7 CFR 2.17(e), section 302(b) of the Act that it has 2.56. been determined by the Secretary to come within the definition of ‘‘stock- DEFINITIONS yard’’ under section 302(a) of the Act. § 201.1 Meaning of words. (j) Schedule means a tariff of rates and charges filed by stockyard owners Words used in this part in the singular form shall be deemed to import and market agencies. the plural, and vice versa, as the case (k) Custom Feedlot means any facility may demand. which is used in its entirety or in part for the purpose of feeding livestock for [19 FR 4524, July 22, 1954] the accounts of others, but does not in- § 201.2 Terms defined. clude feeding incidental to the sale or transportation of livestock. The definitions of terms contained in the Act shall apply to such terms when [46 FR 50510, Oct. 14, 1981] used in the Regulations under the Packers and Stockyards Act, 9 CFR ADMINISTRATION part 201; Rules of Practice Governing Proceedings under the Packers and § 201.3 Authority. Stockyards Act, 9 CFR part 202; State- The Administrator shall perform ments of General Policy under the such duties as the Secretary may re- Packers and Stockyards Act, 9 CFR quire in enforcing the provisions of the part 203; and Organization and Func- act and the regulations in this part. tions, 9 CFR part 204. In addition the following terms used in these parts [19 FR 4524, July 22, 1954] shall be construed to mean: (a) Act means the Packers and Stock- APPLICABILITY OF INDUSTRY RULES yards Act, 1921, as amended and supplemented (7 U.S.C. 181 et seq.). § 201.4 Bylaws, rules and regulations, (b) Department means the United and requirements of exchanges, as- States Department of Agriculture. sociations, or other organizations; (c) Secretary means the Secretary of applicability, establishment. Agriculture of the United States, or (a) The regulations in this part shall any officer or employee of the Depart- not prevent the legitimate application ment authorized to act for the Sec- or enforcement of any valid bylaw, rule retary. or regulation, or requirement of any (d) Administration or agency means exchange, association, or other organi- the Grain Inspection, Packers and zation, or any other valid law, rule or Stockyards Administration (Packers regulation, or requirement to which and Stockyards Programs). any packer, stockyard owner, market (e) Administrator or agency head agency, or dealer shall be subject means the Administrator of the Ad- which is not inconsistent or in conflict ministration or any person authorized with the act and the regulations in this to act for the Administrator. (f) Regional Supervisor means the re- part. gional supervisor of the Grain Inspec- (b) Market agencies selling livestock tion, Packers and Stockyards Adminis- on commission shall not, in carrying tration (Packers and Stockyards Pro- out the statutory duty imposed upon grams) for a given area or any person them by section 307 of title III of the authorized to act for the regional su- act, permit dealers, packers, or others pervisor. representing interests which conflict (g) Person means individuals, partner- with those of consignors, to partici- ships, corporations, and associations. pate, directly or indirectly, in deter- (h) Registrant means any person reg- mination of the need for, or in the es- istered pursuant to the provisions of tablishment of, regulations governing,

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or practices relating to, the respon- Agency, and the bond as required in sibilities, duties, or obligations of such § 201.27 through 201.34. market agencies to their consignors. (Approved by the Office of Management and (7 U.S.C. 181 et seq.) Budget under control number 0590–0001) [19 FR 4524, July 22, 1954, as amended at 44 (7 U.S.C. 203, 204, 207, 217a, 222 and 228) FR 45361, Aug. 2, 1979] [49 FR 33003, Aug. 20, 1984, as amended at 54 FR 37094, Sept. 7, 1989; 56 FR 2127, Jan. 22, REGISTRATION 1991]

§ 201.10 Requirements and procedures. § 201.11 Suspended registrants; offi- (a) Every person operating or desir- cers, agents, and employees. ing to operate as a market agency or Any person whose registration has dealer as defined in section 301 of the been suspended, or any person who was Act shall apply for registration under responsible for or participated in the the Act. To apply for registration, such violation on which the order of suspen- persons shall file a properly executed sion was based, may not register in his application for registration, on forms own name or in any other manner furnished by the Agency, and the bond within the period during which the as required in § 201.27 through 201.34. order of suspension is in effect, and no partnership or corporation in which (b) Each application for registration any such person has a substantial fi- shall be filed with the regional super- nancial interest or exercises manage- visor for the region in which the appli- ment responsibility or control may be cant proposes to operate. If the Admin- registered during such period. istrator has reason to believe that the applicant is unfit to engage in the ac- (7 U.S.C. 203, 204, 207, 217a and 228) tivity for which application has been [49 FR 33003, Aug. 20, 1984] made, a proceeding shall be promptly instituted in which the applicant will SCHEDULES OF RATES AND CHARGES be afforded opportunity for full hearing in accordance with the rules of practice § 201.17 Requirements for filing tariffs. governing such proceedings, for the (a) Schedules of rate changes for stock- purpose of showing cause why the ap- yard services. Each stockyard owner plication for registration should not be and market agency operating at a post- denied. In the event it is determined ed stockyard shall file with the re- that the application should be denied, gional supervisor for the region in the applicant shall not be precluded, as which they operate a signed copy of all soon as conditons warrant, from again schedules of rates and charges, supple- applying for registration. ments and amendments thereto. The (c) Any person regularly employed on schedules, supplements and amend- salary, or other comparable method of ments must be conspicuously posted for public inspection at the stockyard, compensation, by a packer to buy live- and filed with the regional supervisor, stock for such packer shall be subject at least 10 days before their effective to the registration requirements of the dates, except as provided in paragraphs Act and the regulations. Such person (b) and (c) of this section. Each sched- shall be registered as a dealer to pur- ule, supplement and amendment shall chase livestock for slaughter. set forth its effective date, a descrip- (d) Every person clearing or desiring tion of the stockyard services rendered, to clear the buying operations of other the stockyard at which it applies, the registrants shall apply for registration name and address of the stockyard as a market agency providing clearing owner or market agency, the kind of services by filing a properly executed livestock covered by it, and any rules application, on forms furnished by the or regulations which affect any rate or

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charge contained therein. Each sched- failed or refused to satisfy its legal ob- ule of rates and charges filed shall be ligations under bonds issued under said designated by successive numbers. regulations. Each supplement and amendment to (b) Any packer, market agency, or such schedule shall be numbered and dealer required to maintain a surety shall designate the number of the bond under these regulations may elect schedule which it supplements or to maintain, in whole or partial substi- amends. tution for such surety bond, a bond (b) Feed charges. When the schedule equivalent, or combination thereof, in effect provides for feed charges to be must be the total amount of the surety based on an average cost plus a speci- bond otherwise required under these fied margin, the 10-day filing and no- regulations. Any such bond equivalent tice provision contained in section must be in the form of: 306(c) of the Act is waived. A schedule (1) A trust fund agreement governing of the current feed charges based on av- funds actually deposited or invested in erage feed cost and showing the effec- fully negotiable obligations of the tive date shall be conspicuously posted United States or Federally-insured de- at the stockyard at all times. Changes posits or accounts in the name of and in feed charges may become effctive 2 readily convertible to currency by a days after the change is posted at the trustee as provided in § 201.32, or stockyard. (2) A trust agreement governing (c) Professional veterinary services. The funds which may be drawn by a trustee 10-day filing and notice provision con- as provided in § 201.32, under one or tained in section 306(a) of the Act is more irrevocable, transferrable, stand- waived for a schedule of charges for by letters of credit, issued by a Feder- professional veterinary services. A ally-insured bank or institution and schedule of charges for professional physically received and retained by veterinary services rendered by a vet- such trustee. erinarian at a posted stockyard shall (c) The provisions of §§ 201.27 through be conspicuously posted at the stock- 201.34 shall be applicable to the trust yard at all times. The schedule of fund agreements, trust agreements and charges and any supplement or amend- letters of credit authorized in para- ment thereto may become effective 2 graph (b) of this section. days after the schedule, supplement, or (d) Bonds, trust fund agreements, let- amendment is posted at the stockyard. ters of credit and trust agreements shall be filed on forms approved by the (d) Joint schedules. If the same sched- Administrator. ule is to be observed by more than one market agency operating at any one (Approved by the Office of Management and stockyard, one schedule will suffice for Budget under control number 0590–0001) such market agencies. The names and [56 FR 2128, Jan. 22, 1991, as amended at 61 business addresses of those market FR 36279, July 10, 1996] agencies adhering to such schedule must appear on the schedule. § 201.28 Duplicates of bonds or equivalents to be filed with Regional Su- (Approved by the Office of Management and pervisors. Budget under control number 0590–0001) Fully executed duplicates of bonds, (7 U.S.C. 203, 204, 207, 217a, 222 and 228) trust fund agreements, and trust agree- [49 FR 33003, Aug. 20, 1984] ments maintained under the regulations in this part, and fully executed GENERAL BONDING PROVISIONS duplicates of all endorsements, amendments, riders, indemnity agreements, § 201.27 Underwriter; equivalent in and other attachments thereto, and lieu of bonds; standard forms. photographically reproduced copies of (a) The surety on bonds maintained any letter of credit or amendment under the regulations in this part shall thereto, shall be filed with the Re- be a surety company which is currently gional Supervisor for the region in approved by the United States Treas- which the registrant, packer, or person ury Department for bonds executed to applying for registration resides, or in the United States; and which has not the case of a corporation, where the

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corporation has its home office: Pro- ket agency selling livestock on a com- vided, that if such registrant, packer, mission basis shall file and maintain or person does not engage in business its own bond. in such area, the foregoing documents (d) Every packer purchasing live- shall be filed with the Regional Super- stock,irectly or through an affiliate or visor for the region in which the place employee or a wholly-owned subsidi- of business of the registrant or packer ary, except those packers whose annual or person is located. purchases do not exceed $500,000, shall (Approved by the Office of Management and file and maintain a reasonable bond. In Budget under control number 0590–0001) the event a packer maintains a wholly- owned subsidiary or affiliate to con- [56 FR 2128, Jan. 22, 1991] duct its livestock buying, the wholly- MARKET AGENCY, DEALER AND PACKER owned subsidiary or affiliate shall be BONDS registered as a packer buyer for its parent packer firm, and the required bond § 201.29 Market agencies, packers and shall be maintained by the parent dealers required to file and main- packer firm. tain bonds. (7 U.S.C. 204, 228(a)) (a) Every market agency, packer, and dealer, except as provided in paragraph [48 FR 8806, Mar. 2, 1983] (d) of this section, and except packer buyers registered as dealers to pur- § 201.30 Amount of market agency, chase livestock for slaughter only, dealer and packer bonds. shall execute and maintain a reason- (a) Market agency selling livestock on able bond on forms approved by the Ad- commission. To compute the required ministrator containing the appropriate amount of bond coverage, divide the condition clauses, as set forth in dollar value of livestock sold during § 201.31 of the regulations, applicable to the preceding business year, or the sub- the activity or activities in which the stantial part of that business year, in person or persons propose to engage, to which the market agency did business, secure the performance of obligations by the actual number of days on which incurred by such market agency, pack- livestock was sold. The divisor (the er, or dealer. No market agency, pack- number of days on which livestock was er, or dealer required to maintain a sold) shall not exceed 130. The amount bond shall conduct his operations unof bond coverage must be the next mul- less there is on file and in effect a bond tiple of $5,000 above the amount so de- complying with the regulations in this termined. When the computation ex- part. ceeds $50,000, the amount of bond cov- (b) Every market agency buying on a erage need not exceed $50,000 plus 10 commission basis and every dealer buy- percent of the excess over $50,000, ing for his own account or for the ac- raised to the next $5,000 multiple. In no counts of others shall file and maintain case shall the aamount of bond cov- a bond. If a registrant operates as both erage for a market agency selling on a market agency buying on a commis- commission be less than $10,000 or such sion basis and as a dealer, only one higher amount as required to comply bond to cover both buying operations with any State law. need be filed. Any person operating as (b) Market agency buying on commis- a market agency selling on a commission or dealer. The amount of bond cov- sion basis and as a market agency buy- erage must be based on the average ing on a commission basis or as a deal- amount of livestock purchased by the er shall file and maintain separate dealer or market agency during a pe- bonds to cover his selling and buying riod equivalent to 2 business days. To operations. compute the required amount of bond (c) Each market agency and dealer coverage, divide the total dollar value whose buying operations are cleared by of livestock purchased during the pre- another market agency shall be named ceding business year, or substantial as clearee in the bond filed and main- part of that business year, in which the tained by the market agency registered dealer or market agency or both did to provide clearing services. Each mar- business, by one-half the number of

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days on which business was conducted. ness year, in which the packer did busi- The number of days in any business ness, by one-half the number of days on year, for purposes of this regulation, which business was conducted. The shall not exceed 260. Therefore, the di- number of days in any business year, visor (one-half the number of days on for purposes of this regulation, shall which business was conducted) shall not exceed 260. Therefore, the divisor not exceed 130. The amount of the bond (one-half the number of days on which coverage must be the next multiple of business was conducted) shall not ex- $5,000 above the amount so determined. ceed 130. The amount of the bond cov- When the computation exceeds $75,000, erage must be the next multiple of the amount of bond coverage need not $5,000 above the amount so determined. exceed $75,000 plus 10 percent of the ex- In no case shall the amount of bond cess over $75,000, raised to the next coverage for a packer be less than $5,000 multiple. In no case shall the $10,000. amount of bond coverage be less than (e) If a person applying for registra- $10,000 or such higher amount as re- tion as a market agency or dealer has quired to comply with any State law. been engaged in the business of han- (c) Market agency acting as clearing dling livestock before the date of the agency. The amount of bond coverage application, the value of the livestock must be based on the average amount handled, if representative of future op- of livestock purchased by all persons erations, must be used in computing for whom the market agency served as the required amount of bond coverage. a clearor during a period equivalent to If the applicant for registration is a 2 business days. To compute the re- successor in business to a registrant quired amount of bond coverage, divide formerly subject to these regulations, the total dollar value of livestock pur- the amount of bond coverage of the ap- chased by all persons for whom the plicant must be at least that amount market agency served as a clearor dur- required of the prior registrant, unless ing the preceding business year, or sub- otherwise determined by the Adminis- stantial part of that business year, in trator. If a packer becomes subject to which the market agency acting as these regulations, the value of live- clearing agency did business, by one- stock purchased, if representative of half the number of days on which busi- future operations, must be used in ness was conducted. The number of computing the required amount of days in any business year, for purposes bond coverage. If a packer is a succes- of this regulation, shall not exceed 260. sor in business to a packer formerly Therefore, the divisor (one-half the subject to these regulations, the number of days on which business was amount of bond coverage of the succes- conducted) shall not exceed 130. The sor must be at least that amount re- amount of bond coverage must be the quired of the prior packer, unless oth- next multiple of $5,000 above the erwise determined by the Adminis- amount so determined. When the com- trator. putation exceeds $75,000, the amount of (f) Whenever the Administrator has bond coverage need not exceed $75,000 reason to believe that a bond is inad- plus 10 percent of the excess over equate to secure the performance of $75,000, raised to the next $5,000 mul- the obligations of the market agency, tiple. In no case shall the amount of dealer or packer covered thereby, the bond coverage be less than $10,000 or Administrator shall notify such person such higher amount as required to to adjust the bond to meet the require- comply with any State law. ments the Administrator determines to (d) Packer. The amount of bond cov- be reasonable. erage must be based on the average amount of livestock purchased by the (7 U.S.C. 204, 228(a)) packer during a period equivalent to 2 [48 FR 8806, Mar. 2, 1983] business days. To compute the required amount of bond coverage, divide the § 201.31 Conditions in market agency, total dollar value of livestock pur- dealer and packer bonds. chased during the preceding business Each market agency, dealer and year, or substantial part of that busi- packer bond shall contain conditions

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applicable to the activity or activities § 201.32 Trustee in market agency, in which the person or persons named dealer and packer bonds. as principal or clearees in the bond pro- Bonds may be in favor of a trustee pose to engage, which conditions shall who shall be a financially responsible, be as follows or in terms to provide disinterested person satisfactory to the equivalent protection: Administrator. State officials, sec- (a) Condition Clause No. 1: When the retaries or other officers of livestock principal sells livestock for the accounts exchanges or of similar trade associa- of others. If the said principal shall pay tions, attorneys at law, banks and when due to the person or persons enti- trust companies, or their officers, are tled thereto the gross amount, less deemed suitable trustees. If a trustee is lawful charges, for which all livestock not designated in the bond and action is sold for the accounts of others by is taken to recover damages for breach said principal. of any condition thereof, the Adminis- trator shall designate a person to act (b) Condition Clause No. 2: When the as trustee. In those States in which a principal buys livestock for his own ac- State official is required by statute to count or for the accounts of others. If the act or has agreed to act as trustee, said principal shall pay when due to such official shall be designated by the the person or persons entitled thereto Administrator as trustee when a des- the purchase price of all livestock pur- ignation by the Administrator becomes chased by said principal for his own ac- necessary. count or for the accounts of others, and [41 FR 53774, Dec. 9, 1976] if the said principal shall safely keep and properly disburse all funds, if any, § 201.33 Persons damaged may main- which come into his hands for the pur- tain suit; filing and notification of pose of paying for livestock purchased claims; time limitations; legal ex- for the accounts of others. penses. (c) Condition Clause No. 3: When the Each bond and each bond equivalent principal clears other registrants buying filed pursuant to the regulations in livestock and thus is responsible for the this part shall contain provisions that: obligations of such other registrants. If (a) Any person damaged by failure of the said principal, acting as a clearing the principal to comply with any con- agency responsible for the financial ob- dition clause of the bond or bond equivalent may maintain suit to recover on ligations of other registrants engaged the bond or bond equivalent even in buying livestock, viz: (Insert here though such person is not a party the names of such other registrants as named in the bond or bond equivalent; they appear in the application for reg- (b) Any claim for recovery on the istration), or if such other registrants, bond or bond equivalent must be filed shall (1) pay when due to the person or in writing with either the surety, if persons entitled thereto the purchase any, or the trustee, if any, or the Ad- price of all livestock purchased by such ministrator, and whichever of these other registrants for their own account parties receives such a claim shall no- or for the accounts of others; and (2) tify the other such party or parties at safely keep and properly disburse all the earliest practical date; funds coming into the hands of such (c) The Administrator is authorized principal or such other registrants for to designate a trustee pursuant to the purpose of paying for livestock pur- § 201.32; chased for the accounts of others. (d) The surety on the bond, or the (d) Condition Clause No. 4: When the trustee on the bond equivalent, as the principal buys livestock for his own ac- case may be, shall not be liable to pay count as a packer. If the said principal any claim if it is not filed in writing shall pay when due to the person or within 60 days from the date of the persons entitled thereto the purchase transaction on which the claim is price of all livestock purchased by said based or if suit thereon is commenced less than 120 days or more than 547 principal for his own account. days from the date of the transaction [47 FR 32695, July 29, 1982] on which the claim is based;

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(e) The proceeds of the bond or bond tive date of the replacement bond or equivalent, as the case may be, shall bond equivalent. not be used to pay fees, salaries, or ex- (Approved by the Office of Management and penses for legal representation of the Budget under control number 0590–0001) surety or the principal. [47 FR 32695, July 29, 1982, as amended at 54 [56 FR 2128, Jan. 22, 1991] FR 26349, June 23, 1989; 61 FR 36279, July 10, 1996] § 201.34 Termination of market agency, dealer and packer bonds. PROCEEDS OF SALE (a) Each bond shall contain a provision requiring that, prior to terminat- § 201.39 Payment to be made to consignor or shipper by market agen- ing such bond, at least 30 days notice cies; exceptions. in writing shall be given to the Admin- istrator, Grain Inspection, Packers and (a) No market agency shall, except as Stockyards Administration (Packers provided in paragraph (b) of this sec- and Stockyards Programs), U.S. De- tion, pay the net proceeds or any part partment of Agriculture, Washington, thereof, arising from the sale of live- DC 20250, by the party terminating the stock consigned to it for sale, to any bond. Such provision may state that in person other than the consignor or the event the surety named therein shipper of such livestock except upon writes a replacement bond for the same an order from the Secretary or a court of competent jurisdiction, unless (1) principal, the 30-day notice require- such market agency has reason to be- ment may be waived and the bond will lieve that such person is the owner of be terminated as of the effective date the livestock, (2) such person holds a of the replacement bond. valid, unsatisfied mortgage or lien (b) Each bond filed by a market agen- upon the particular livestock, or (3) cy who clears other registrants who are such person holds a written order au- named in the bond shall contain a pro- thorizing such payment executed by vision requiring that, prior to termi- the owner at the time of or imme- nating the bond coverage of any diately following the consignment of clearee named therein, at least 30 days such livestock: Provided, That this notice in writing shall be given to the paragraph shall not apply to deduc- Administrator, Grain Inspection, Pack- tions made from sales proceeds for the ers and Stockyards Administration purpose of financing promotion and re- (Packers and Stockyards Programs), search activities, including educational U.S. Department of Agriculture, Wash- activities, relating to livestock, meat, ington, DC 20250, by the surety. Such and other products covered by the Act, written notice shall be in the form of a carried out by producer-sponsored or- rider or endorsement to be attached to ganizations. the bond of the clearing agency. (b) The net proceeds arising from the (c) Each trust fund agreement and sale of livestock, the ownership of trust agreement shall contain a provi- which has been questioned by a market sion requiring that, prior to terminat- agency duly authorized to inspect ing such agreement, at least 30 days brands, marks, and other identifying notice in writing shall be given to the characteristics of livestock may be Administrator, Grain Inspection, Pack- paid in accordance with the directions ers and Stockyards Administration, of such brand inspection agency if the U.S. Department of Agriculture, Wash- laws of the State from which such live- ington, DC 20250, by the party termi- stock originated or was shipped to nating the agreement. Such provision market make provision for payment of shall state that in the event the prin- the proceeds in the manner directed by cipal named therein files an acceptable the brand inspection agency and if the bond or bond equivalent to replace the market agency to which the livestock agreement, the 30-day notice require- was consigned, and the consignor or ment may be waived and the agree- consignors concerned, are unable to es- ment will be terminated as of the effec- tablish the ownership of the livestock

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within a reasonable period of time, not charges against the consignment of to exceed 60 days after sale. livestock which the market agency shall, in its capacity as agent, be re- (7 U.S.C. 181 et seq.) quired to pay, and (3) to obtain any [19 FR 4528, July 22, 1954, as amended at 28 sums due the market agency as com- FR 7218, July 13, 1963; 44 FR 45361, Aug. 2, pensation for its services. 1979] (e) Accounts and records. Each market § 201.42 Custodial accounts for trust agency shall keep such accounts and funds. records as will disclose at all times the handling of funds in such custodial ac- (a) Payments for livestock are trust counts for shippers’ proceeds. Accounts funds. Each payment that a livestock and records must at all times disclose buyer makes to a market agency sell- the name of the consignors and the ing on commission is a trust fund. amount due and payable to each from Funds deposited in custodial accounts funds in the custodial account for ship- are also trust funds. pers’ proceeds. (b) Custodial accounts for shippers’ pro- (f) Insured banks. Such custodial ac- ceeds. Every market agency engaged in counts for shippers’ proceeds must be selling livestock on a commission or established and maintained in banks agency basis shall establish and main- whose deposits are insured by the Fed- tain a separate bank account des- eral Deposit Insurance Corporation. ignated as ‘‘Custodial Account for (g) Certificates of deposit and/or savings Shippers’ Proceeds,’’ or some similar accounts. Funds in a custodial account identifying designation, to disclose for shippers’ proceeds may be main- that the depositor is acting as a fidu- tained in an interest-bearing savings ciary and that the funds in the account account and/or invested in one or more are trust funds. (c) Deposits in custodial accounts. The certificates of deposit, to the extent market agency shall deposit in its cus- that such deposit or investment does todial account before the close of the not impair the ability of the market next business day (the next day on agency to meet its obligations to its which banks are customarily open for consignors. The savings account must business whether or not the market be properly designated as a party of the agency does business on that day) after custodial account of the market agen- livestock is sold (1) the proceeds from cy in its fiduciary capacity as trustee the sale of livestock that have been of the custodial funds and maintained collected, and (2) an amount equal to in the same bank as the custodial ac- the proceeds receivable from the sale of count. The certificates of deposit, as livestock that are due from (i) the mar- property of the custodial account, ket agency, (ii) any owner, officer, or must be issued by the bank in which employee of the market agency, and the custodial account is kept and must (iii) any buyer to whom the market be made payable to the market agency agency has extended credit. The mar- in its fiduciary capacity as trustee of ket agency shall thereafter deposit in the custodial funds. the custodial account all proceeds col- (Approved by the Office of Management and lected until the account has been reim- Budget under control number 0590–0001) bursed in full, and shall, before the [47 FR 32696, July 29, 1982, as amended at 54 close of the seventh day following the FR 26349, June 23, 1989] sale of livestock, deposit an amount equal to all the remaining proceeds re- ACCOUNTS AND RECORDS ceivable whether or not the proceeds have been collected by the market § 201.43 Payment and accounting for agency. livestock and live poultry. (d) Withdrawals from custodial ac- (a) Market agencies to make prompt accounts. The custodial account for ship- counting and transmittal of net proceeds. pers’ proceeds shall be drawn on only Each market agency shall, before the for payment of (1) the net proceeds to close of the next business day following the consignor or shipper, or to any per- the sale of any livestock consigned to son that the market agency knows is it for sale, transmit or deliver to the entitled to payment, (2) to pay lawful consignor or shipper of the livestock,

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or the duly authorized agent, in the ab- cass’’ or ‘‘grade and yield’’ basis, on or sence of any knowledge that any other before the close of the first business person, or persons, has any interest in day following determination of the pur- the livestock, the net proceeds received chase price; or unless (B) the seller ex- from the sale and a true written ac- pressly agrees in writing before the count of such sale, showing the num- transaction that payment may be made ber, weight, and price of each kind of by such mailing of a check. animal sold, the date of sale, the com- (3) Any agreement referred to in mission, yardage, and other lawful paragraph (b) (1) or (2) of this section charges, and such other facts as may be shall be disclosed in the records of any necessary to complete the account and market agency or dealer selling such show fully the true nature of the trans- livestock, and in the records of the action. packer, market agency, or dealer pur- (b) Prompt payment for livestock and chasing such livestock, and retained by live poultry—terms and conditions. (1) No such person for such time as is required packer, market agency, or dealer shall by any law, or by written notice served purchase livestock for which payment on such person by the Administrator, is made by a draft which is not a but not less than two calendar years check, unless the seller expressly from the date of expiration thereof. agrees in writing before the trans- (4) No packer, live poultry dealer, action that payment may be made by market agency, or livestock dealer such a draft. (In cases of packers whose shall as a condition to its purchase of average annual purchases exceed livestock or poultry, impose, demand, $500,000, and market agencies and deal- compel or dictate the terms or manner ers acting as agents for such packers, of payment, or attempt to obtain a see also § 201.200). payment agreement from a seller (2)(i) No packer, market agency, or through any threat of retaliation or dealer purchasing livestock for cash other form of intimidation. and not on credit, whether for slaugh- (c) Purchaser to promptly reimburse ter or not for slaughter, shall mail a agents. Each packer, market agency, or check in payment for the livestock un- dealer who utilizes or employs an agent less the check is placed in an envelope to purchase livestock for him, shall, in with proper first class postage prepaid transactions where such agent uses his and properly addressed to the seller or own funds to pay for livestock pur- such person as he may direct, in a post chased on order, transmit or deliver to office, letter box, or other receptacle such agent the full amount of the pur- regularly used for the deposit of mail chase price before the close of the next business day following receipt of notifi- for delivery, from which such envelope cation of the payment of such purchase is scheduled to be collected (A) before price, unless otherwise expressly the close of the next business day fol- agreed between the parties before the lowing the purchase of livestock and purchase of the livestock. Any such transfer of possession thereof, or (B) in agreement shall be disclosed in the the case of a purchase on a ‘‘carcass’’ records of the principal and in the or ‘‘grade and yield’’ basis, before the records of any market agency or dealer close of the first business day following acting as such agent. determination of the purchase price. (ii) No packer, market agency, or (Approved by the Office of Management and dealer purchasing livestock for slaugh- Budget under control number 0590–0001) ter, shall mail a check in payment for (7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46) the livestock unless (A) the check is [49 FR 6083, Feb. 17, 1984, as amended at 49 made available for actual delivery and FR 8235, Mar. 6, 1984; 54 FR 16355, Apr. 24, the seller or his duly authorized rep- 1989] resentative is not present to receive payment, at the point of transfer of § 201.44 Market agencies to render possession of such livestock, on or be- prompt accounting for purchases fore the close of the next business day on order. following the purchase of the livestock Each market agency shall, promptly and transfer of possession thereof, or, following the purchase of livestock on in the case of a purchase on a ‘‘car- a commission or agency basis, transmit

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or deliver to the person for whose ac- cass weight or carcass grade and count such purchase was made, or the weight basis, the hot carcass weights duly authorized agent, a true written shall be recorded using a scale account of the purchase showing the equipped with a printing device, and number, weight, and price of each kind such printed weights shall be retained of animal purchased, the names of the as part of the person or firm’s business persons from whom purchased, the date records to substantiate settlement on of purchase, the commission and other each transaction. Scale tickets issued lawful charges, and such other facts as under this section shall show: may be necessary to complete the ac- (1) The names and location of the count and show fully the true nature of agency performing the weighing serv- the transaction. ice, (2) The date of the weighing; (Approved by the Office of Management and Budget under control number 0590–0001) (3) The name of the buyer and seller or consignor, or a designation by which (7 U.S.C. 181 et seq.) they may be readily identified; [44 FR 45360, Aug. 2, 1979, as amended at 54 (4) The number of head; FR 26349, June 23, 1989] (5) Kind of livestock; (6) Actual weight of each draft of § 201.45 Market agencies to make livestock; and records available for inspection by owners, consignors, and pur- (7) The name, initials, or number of chasers. the person who weighed the livestock, or if required by State law, the signa- Each market agency engaged in the ture of the weigher. business of selling or buying livestock (b) Poultry. When live poultry is on a commission or agency basis shall, weighed for the purpose of purchase, on request from an owner, consignor, sale, acquisition, or settlement by a or purchaser, make available copies of live poultry dealer, a scale ticket shall bills covering charges paid by such be issued which shall show: market agency for and on behalf of the (1) The name of the agency perform- owner, consignor, or purchaser which ing the weighing service; were deducted from the gross proceeds (2) The name of the live poultry deal- of the sale of livestock or added to the er; purchase price thereof when account- (3) The name and address of the growing for the sale or purchase. er, purchaser, or seller; (Approved by the Office of Management and (4) The name or initials or number of Budget under control number 0590–0001) the person who weighed the poultry, or (7 U.S.C. 181 et seq.; Pub. L. 96–511, 94 Stat. if required by State law, the signature 2812 (44 U.S.C. 3501 et seq.)) of the weigher; [19 FR 4528, July 22, 1954, as amended at 44 (5) The location of the scale; FR 45361, Aug. 2, 1979; 47 FR 746, Jan. 7, 1982; (6) The gross weight, tare weight, and 54 FR 26349, June 23, 1989] net weight; (7) The date and time gross weight § 201.49 Requirements regarding scale and tare weight are determined; tickets evidencing weighing of live- (8) The number of poultry weighed; stock and live poultry. (9) The weather conditions; (a) Livestock. When livestock is (10) Whether the driver was on or off weighed for the purpose of purchase or the truck at the time of weighing; and sale, a scale ticket shall be issued (11) The license number of the truck which shall be serially numbered and or the truck number; provided, that used in numerical sequence. Sufficient when live poultry is weighed on a scale copies shall be executed to provide a other than a vehicle scale, the scale copy to all parties to the transaction. ticket need not show the information In instances where the weight values specified in paragraphs (b)(9)–(11) of are automatically recorded directly on this section. Scale tickets issued under the account of purchase, account of this paragraph shall be at least in du- sale or other basic record, this record plicate form and shall be serially num- may serve in lieu of a scale ticket. bered and used in numerical sequence. When livestock is purchased on a car- One copy shall be furnished to the

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grower, purchaser, or seller, and one of selling livestock on a commission copy shall be furnished to or retained basis shall purchase livestock from by the live poultry dealer. consignments, and no such market agency shall permit its owners, offi- (Approved by the Office of Management and Budget under control number 0590–0001) cers, agents, employees or any firm in which such market agency or its own- [61 FR 36281, July 10, 1996] ers, officers, agents, or employees have an ownership or financial interest to TRADE PRACTICES purchase livestock consigned to such § 201.53 Persons subject to the Act not market agency, without first offering to circulate misleading reports the livestock for sale in an open and about market conditions or prices. competitive manner to other available No packer, live poultry dealer, stock- buyers, and then only at a price higher yard owner, market agency, or dealer than the highest available bid on such shall knowingly make, issue, or cir- livestock. culate any false or misleading reports, (c) Key employees not to purchase live- records, or representation concerning stock out of consignments. No market the market conditions or the prices or agency engaged in selling livestock on sale of any livestock, meat, or live commission shall permit its auc- tioneers, weighmasters, or salesmen to poultry. purchase livestock out of consignment [54 FR 16355, Apr. 24, 1989] for any purpose for their own account, either directly or indirectly. § 201.55 Purchases, sales, acquisitions, (d) Purchase from consignments; disclo- and settlements to be made on ac- sure required. When a market agency tual weights. purchases consigned livestock or sells When livestock or live poultry is consigned livestock to any owner, offi- bought, sold, acquired, or settled on a cer, agent, employee, or any business weight basis, settlement therefor shall in which such market agency, owner, be on the basis of the actual weight on officer, agent, or employee has an own- the scale ticket. If the actual weight ership or financial interest, the market used is not obtained on the date and at agency shall disclose on the account of the place of transfer of possession, this sale the name of the buyer and the na- information shall be disclosed with the ture of the relationship existing be- date and location of the weighing on tween the market agency and the the accountings, bills, or statement is- buyer. sued. Any adjustment to the actual (Approved by the Office of Management and weights shall be fully and accurately Budget under control number 0590–0001.) explained on the accountings, bills, or statements issued and records shall be (7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46) maintained to support such adjust- [49 FR 6084, Feb. 17, 1984, as amended at 49 ment. FR 13003, Apr. 2, 1984; 58 FR 52886, Oct. 13, 1993] (Approved by the Office of Management and Budget under control number 0590–0001) § 201.61 Market agencies selling or [61 FR 36281, July 10, 1996] purchasing livestock on commission; relationships with dealers. § 201.56 Market agencies selling on (a) Market agencies selling on commis- commission; purchases from con- sion. No market agency selling consignment. signed livestock shall enter into any (a) Livestock to be sold openly at high- agreement, relationship or association est available bid. Every market agency with dealers or other buyers which has engaged in the business of selling live- a tendency to lessen the loyalty of the stock on a commission or agency basis market agency to its consignors or im- shall sell the livestock consigned to it pair the quality of the market agency’s openly, at the highest available bid, selling services. No market agency and in such a manner as to best pro- selling livestock on commission shall mote the interest of each consignor. provide clearing services for any inde- (b) Purchases from consignment. No pendent dealer who purchases livestock market agency engaged in the business from consignment to such market

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agency without disclosing, on the ac- ume of livestock to be purchased, or count of sale to the consignor, the prices to be paid; or (b) furnish any name of the buyer and the nature of other buying information to competi- the financial relationship between the tor buyers. buyer and the market agency. (b) Market agencies buying on commis- [19 FR 4531, July 22, 1954, as amended at 24 FR 3183, Apr. 24, 1959] sion. No market agency purchasing livestock on commission shall enter § 201.70 Restriction or limitation of into any agreement, relationship, or competition between packers and association with dealers or others dealers prohibited. which will impair the quality of the buying services furnished to its prin- Each packer and dealer engaged in cipals. No market agency purchasing purchasing livestock, in person or livestock on commission shall, in fill- through employed buyers, shall con- ing orders, purchase livestock from a duct his buying operations in competi- dealer whose operations it clears or fi- tion with, and independently of, other nances without disclosing the relation- packers and dealers similarly engaged. ship between the market agency and [24 FR 3183, Apr. 24, 1959] dealer to its principals on the accountings furnished to the principals. SERVICES (Approved by the Office of Management and Budget under control number 0590–0001) § 201.71 Scales; accurate weights, repairs, adjustments or replacements (7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46) after inspection. [49 FR 6085, Feb. 17, 1984, as amended at 60 (a) All scales used by stockyard own- FR 42779, Aug. 17, 1995] ers, market agencies, dealers, packers, and live poultry dealers to weigh live- § 201.67 Packers not to own or finance selling agencies. stock, livestock carcasses, or live poultry for the purpose of purchase, sale, No packer subject to the Act shall acquisition, or settlement shall be in- have an ownership interest in, finance, stalled, maintained, and operated to in- or participate in the management or sure accurate weights. Such scales operation of a market agency selling shall meet applicable requirements livestock on a commission basis, nor contained in the General Code, Scale shall such a market agency permit a Code, and Weights Code of the 1996 edi- packer to have an ownership interest tion of National Institute of Standards in, finance, or participate in the man- and Technology Handbook 44, ‘‘Speci- agement or operation of such market fications, Tolerances, and Other Tech- agency. nical Requirements for Weighing and (7 U.S.C. 228, 228b, 222, 15 U.S.C. 46) Measuring Devices,’’ which is hereby [49 FR 32844, Aug. 17, 1984] incorporated by reference. This incorporation by reference was approved by § 201.69 Furnishing information to the Director of the Federal Register on competitor buyers. January 11, 1989. These materials are No packer, dealer, or market agency, incorporated as they exist on the date in connection with transactions sub- of approval and a notice of any change ject to the provisions of the act, shall, in these materials will be published in in person, or through employed buyers, the FEDERAL REGISTER. This handbook for the purpose of restricting or limit- is for sale by the Superintendent of ing competition, manipulating live- Documents, U.S. Government Printing stock prices, or controlling the move- Office, Washington, DC 20402. It is also ment of livestock, prior to, or during available for inspection at the Office of the conduct of, his buying operations: the Federal Register Information Cen- (a) Furnish competitor packers, deal- ter, 800 North Capitol Street, NW., ers, market agencies, or their buyers or suite 700, Washington, DC 20408. representatives, similarly engaged in (b) All scales used by stockyard own- buying livestock, with information ers, market agencies dealers, packers, concerning his proposed buying oper- and live poultry dealers to weigh live- ations, such as the species, classes, vol- stock or live poultry for the purpose of

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purchase, sale, acquisition, or settle- of purchase, sale, acquisition or settlement and all scales used for the pur- ment shall furnish reports of such tests chase, sale, acquisition, or settlement and inspections on forms prescribed by of livestock on a carcass weight basis the Administrator. The stockyard shall be equipped with a printing de- owner, market agency, dealer, packer vice which shall be used for recording or live poultry dealer shall retain one weight values on a scale ticket or other copy of the test and inspection report document used for this purpose. and shall file one copy with the re- (c) All vehicle scales used to weigh gional office for the region in which livestock or live poultry for purposes of the scale is located. purchase, sale, acquisition or settle- (c) When the scales used for weighing ment shall be of sufficient length and livestock, livestock carcasses or live capacity to weigh the entire vehicle as poultry are tested and inspected by an a unit: Provided, That a trailer may be agency of a State or municipality or uncoupled from the tractor and other governmental subdivision, the weighed as a single unit. forms ordinarily used by such agency (d) No scales shall be operated or for reporting test and inspection of used by any stockyard owner, market scales shall be accepted in lieu of the agency, dealer, packer, or live poultry forms prescribed for this purpose by dealer to weigh livestock, livestock the Administrator if such forms con- carcasses or live poultry for purposes tain substantially the same informa- of purchase, sale, acquisition or settle- tion. ment unless it has been found upon test and inspection, as specified in (Approved by the Office of Management and Budget under control number 0590–0001) § 201.72 of the regulations, to be in a condition to give accurate weight. If a (7 U.S.C. 222 and 228 and 15 U.S.C. 46) scale is inspected or tested and found [49 FR 37374, Sept. 24, 1984, as amended at 54 incorrect or inaccurate or if any re- FR 16355, Apr. 24, 1989] pairs, adjustments or replacements are made to a scale, it shall not be used § 201.73 Scale operators to be quali- until it has been inspected and tested fied. and met all accuracy requirements Stockyard owners, market agencies, specified in the regulations. dealers, packers and live poultry deal- (7 U.S.C. 222 and 228 and 15 U.S.C. 46) ers shall employ qualified persons to operate scales for weighing livestock, [49 FR 37374, Sept. 24, 1984, as amended at 61 livestock carcasses or live poultry for FR 36282, July 10, 1996] the purpose of purchase, sale acquisi- § 201.72 Scales; testing of. tion or settlement, and they shall require such employees to operate the (a) Each stockyard owner, market scales in accordance with the regula- agency, dealer, packer, or live poultry tions. dealer who weighs livestock or live poultry for purposes of purchase, sale, [54 FR 16356, Apr. 24, 1989] acquisition or settlement, or who weighs livestock carcasses for the pur- § 201.73–1 Instructions for weighing pose of purchase on a carcass weight livestock. basis, or who furnishes scales for such Stockyard operators, market agen- purposes, shall cause such scales to be cies, dealers, and packers who operate tested by competent persons in accord- scales on which livestock is weighed in ance with the regulations at least purchase or sales transactions are re- twice during each calendar year at in- sponsible for the accurate weighing of tervals of approximately six months. such livestock. They shall supply cop- More frequent testing will be required ies of the instructions in this section in cases where the scale does not main- to all persons who perform weighing tain accuracy between tests. operations for them and direct such (b) Each stockyard owner, market person to familiarize themselves with agency, dealer, packer or live poultry the instructions and to comply with dealer who weighs livestock, livestock them at all times. This section shall carcasses or live poultry for purposes also apply to any additional weighers

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who are employed at any time. Weigh- the trig loop, swings freely in the trig ers must acknowledge their receipt of loop in such manner that it will come these instructions and agree to comply to rest at the center of the trig loop. with them, by signing in duplicate, (5) Dial scales shall be balanced by P&SA Form 215 provided by the Pack- releasing all drop weights and operat- ers and Stockyards Programs. One ing the balance ball or other balancing copy of the form is to be filed with a device to obtain a correct zero balance. regional office of the Packers and The indicator must visually indicate Stockyards Programs and the other re- zero on the dial and the ticket printer tained by the agency employing the must record a correct zero balance. weighers. (6) Electronic digital scales should be (a) Balancing the empty scale. (1) The properly warmed up before use. In most empty scale shall be balanced each day cases, it is advisable to leave the elec- before weighing begins, and maintained tric power on continuously. The zero in correct balance which weighing operations continue. The zero balance load balance shall be verified by re- shall be verified at intervals of not cording the zero balance on a scale more than 15 drafts or 15 minutes, ticket. The main indicating element whichever is completed first. In addi- and the remote visual weight display tion, the zero balance of the scale shall shall indicate zero when the balance is be verified whenever a weigher resumes verified. The proper procedure for bal- weighing duties after an absence from ancing this type of scale will vary ac- the scale and also whenever a load ex- cording to the manufacturer. Refer to ceeding half the scale capacity or 10,000 the operator’s manual for specific in- pounds (whichever is less) has been structions. weighed and is followed by a load of (b) Weighing the load. (1) Before less than 1,000 pounds, verification to weighing a draft of livestock, the occur before the weighing of the load of weigher shall assure himself that the less than 1,000 pounds. entire draft is on the scale platform (2) The time at which the empty with the gates closed and that no per- scale is balanced or its zero balance sons or animals off the scale are in con- verified shall be recorded on scale tick- tact with the platform, gates, or stock ets or other permanent records. Bal- rack. ance tickets must be filed with other (i) On a weighbeam scale with a bal- scale tickets issued on that date. ance indicator, the weight of a draft (3) Before balancing the empty scale, shall be determined by seating the the weigher shall assure himself that poises at such positions that the point- the scale gates are closed and that no er will come to rest within the central persons or animals are on the scale target area or within 1⁄4 (0.25) inch of platform or in contact with the stock the zero mark. rack, gates, or platform. If the scale is (ii) On a weighbeam scale without a balanced with persons on the scale balance indicator, the weight shall be platform, the zero balance shall be determined by seating the poises at verified whenever there is a change in such positions that the weighbeam, such persons. When the scale is prop- when released from the top or bottom erly balanced and ready for weighing, of the trig loop, will swing freely and the weigher shall so indicate by an ap- come to rest at the approximate center propriate signal. (4) Weighbeam scales shall be bal- of the trig loop. anced by first seating each poise se- (iii) On a dial scale, the weight is in- curely in its zero notch and then mov- dicated automatically when the indica- ing the balance ball to such position tor moves around the dial face and that a correct zero balance is obtained. comes to rest. A scale equipped with a balance indica- (iv) On an electronic digital scale, tor is correctly balanced when the the weight of a draft is indicated auto- pointer comes to rest at zero. A scale matically when the weight value indi- not equipped with a balance indicator cated stabilized. is correctly balanced if the weighbeam, (2) The correct weight of a livestock when released at the top or bottom of draft is the value in pounds indicated

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when a correct load balance is ob- (4) When weight values are recorded tained. The weigher should always con- by means of automatic recording centrate his attention upon the beam equipment directly on the accounts of tip, balance indicator or dial indicator sale or other basic records, such record while weighing and not concern himself may serve in lieu of a scale ticket. with reading the visible weight indica- (e) Weigher’s responsibilities. (1) The tions until correct load balance is ob- primary responsibility of a weigher is tained. On electronic digital scales, the to determine and accurately record the weigher should concentrate on the weight of livestock drafts without prej- pulsing or flickering of weight values udice or favor to any person or agency to assure that the unit indicates a sta- and without regard for livestock own- ble weight before activating the print ership, price, condition, fill, shrink, or button. other considerations. A weigher shall (c) Recording the weight. (1) The not permit the representations or atti- weight of each draft shall be recorded tudes of any persons or agencies to in- immediately after the load balance is fluence his judgment or action in per- obtained and before any poises are forming his duties. moved or the load is removed from the (2) Unused scale tickets, or those scale platform. The weigher shall make which are partially executed but with- certain that the printed weight record out a printed weight value, shall not be agrees with the weight value visually left exposed or accessible to unauthor- indicated when correct load balance is ized personnel. All such tickets shall be obtained. He shall also assure himself kept under lock when the weigher is that the printed weight value is dis- not at his duty station. tinct and legible. (3) Accurate weighing and correct (2) The weight printing device on a weight recording require that a weigh- scale shall be operated only to produce er shall not permit his operations to be hurried to the extent that inaccurate a printed or impressed record of the weights or incorrect weight records weight value while the livestock load may result. Each draft of livestock is on the scale and correctly balanced. must be weighed accurately to the If the weight value is not printed clear- nearest minimum weight value that ly and correctly, the ticket shall be can be indicated or recorded. Manual marked void and a new one printed be- operations connected with balancing, fore the livestock is removed from the weighing, and recording shall be per- scale. formed with the care necessary to pre- (d) Scale tickets. (1) Scale tickets used vent damage to the accurately ma- to record the weight values of livestock chined and adjusted parts of in purchase or sales transactions shall weighbeams, poises, and printing de- be used, at any given scale, in the order vices. of their consecutive serial numbers un- (4) Livestock owners, buyers, or oth- less otherwise marked to show the ers having legitimate interest in a live- order of their use. All tickets shall stock draft must be permitted to ob- show the date of the weighing and the serve the balancing, weighing, and re- name or initials of the weigher per- cording procedures, and a weigher shall forming the weighing service. not deny them that right or withhold (2) No scale tickets shall be destroyed from them any information pertaining or otherwise disposed of because they to the weight of that draft. He shall are soiled, damaged, incorrectly exe- check the zero balance of the scale or cuted, or voided. They shall be pre- reweigh a draft of livestock when reserved and filed to comprise a complete quested by such parties. serial number sequence. (f) Sensitivity control. (1) A scale must (3) No scale ticket shall be used to be sensitive in response to platform record the weight of a livestock draft loading if it is to yield accurate for ‘‘catch-weight,’’ inventory, trans- weights. It, therefore, is the duty of a portation charge or other nonsale pur- weigher to assure himself that inter- poses unless the ticket is clearly ferences, weighbeam friction, or other marked to show why the weight was factors do not impair sensitivity. He determined. should satisfy himself, at least twice

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each day, that the scale is sufficiently weighing shall not be performed while sensitive, and if the following require- a scale ticket is in the slot of a ments are not met, he should report weighbeam poise. the facts to his superior or employer (2) Stops are provided on scale immediately. weighbeams to prevent movement of (2) A weighbeam scale with a balance poises back of the zero graduation indicator is sufficiently sensitive if, when balancing or weighing. When the when the scale is balanced with the stops become worn or broken and allow pointer at the center of the target, a poise to be set behind the zero posi- movement of the fractional poise one tion, this condition should be reported graduation will change the indicator and corrected without delay. rest point 1⁄4 inch (0.25) or the width of (3) Foreign objects or loose material the central target area, whichever is in the form of nuts, bolts, washers or greater. other material on any part of the (3) A weighbeam scale without a bal- weighbeam assembly, including the ance indicator is sufficiently sensitive counter-balance hanger or counter-bal- if, when the scale is balanced with the ance weights, are potential sources of weighbeam at the center of the trig weighing error. Loose balancing mate- loop, movement of the fractional poise rial must be enclosed in the shot cup of two graduations will cause the the counter-balance hanger, and weighbeam to come to rest at the bot- counter-balance weights must not be of tom of the trig loop. the slotted type which can readily be (4) Adjustable damping devices are removed. incorporated in balance indicators and (4) Whenever for any reason a weigh- in dial scales to absorb the effects of er has reason to believe that a scale is load impact and assist in bringing the not functioning properly or not yield- indicator to rest. The weigher should ing correct weight values, he shall dis- be familiar with the location and ad- continue weighing, report the facts to justment of these damping devices and the parties responsible for scale main- should keep them adjusted so that the pointer will oscillate freely through at tenance, and request inspection, test, least one complete cycle of movement or repair of the scale. before coming to rest at its original po- (5) When a scale has been adjusted, sition. modified, or repaired in any manner (5) Friction at weighbeam bearings which may affect the accuracy of may reduce the sensitivity of the scale, weighing or weight recording, the cause sluggish weighbeam action and weigher shall not use the scale until it affect weighing accuracy. A weigher has been tested and inspected and should inspect the weighbeam assem- found to be accurate. bly daily to make certain that there is (6) Count-off men, gate men, or oth- clearance between the weighbeam and ers assigned to open or close scale the pivot bearings. gates or to drive livestock on or off the (6) Interferences or binding of the scale, shall perform those functions as scale platform, stock rack, gates or directed by the weigher’s signals or other ‘‘live’’ parts of the scale are com- spoken instructions. They shall pre- mon causes of weighing inaccuracy. A vent persons or animals off the scale weigher should satisfy himself, at the from being in contact with any part of beginning of each weighing period, that the scale platform, stock rack, or gates all such ‘‘live’’ parts have sufficient while the scale is being balanced or clearance to prevent interferences. used for weighing. They shall not open (g) General precautions. (1) The poises gates or remove livestock from the of weighbeam scales are carefully ad- scale until directed by the weigher. justed and sealed to a definite weight (Approved by the Office of Management and at the factory and any change in that Budget under control number 0590–0001) weight seriously affects weighing accuracy. A weigher, therefore, should be (7 U.S.C. 222 and 228 and 15 U.S.C. 46) certain that poise parts do not become [39 FR 40277, Nov. 15, 1974, as amended at 49 broken, loose or lost and that no mate- FR 39516, Oct. 9, 1984; 61 FR 36282, July 10, rial is added to a poise. Balancing or 1996]

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§ 201.76 Reweighing. INSPECTION OF BRANDS Stockyard owners, market agencies, § 201.86 Brand inspection: Application dealers, packers and live poultry deal- for authorization, registration and ers shall reweigh livestock, livestock filing of schedules, reciprocal ar- carcasses or live poultry on request of rangements, and maintenance of any authorized representative of the identity of consignments. Secretary. (a) Application for authorization. Any department or agency or duly-orga- [54 FR 16356, Apr. 24, 1989] nized livestock association of any § 201.81 Suspended registrants. State in which branding or marking of livestock as a means of establishing No stockyard owner, packer, market ownership prevails by custom or stat- agency, or dealer shall employ any per- ute, which desires to obtain an author- son who has been suspended as a reg- ization to charge and collect a fee for istrant to perform activities in connec- the inspection of brands, marks, and tion with livestock transactions sub- other identifying characteristics of ject to the jurisdiction of the Secretary livestock, as provided in section 317 of under the Act during the period of such the Act, shall file with the Adminis- suspension: Provided, That the provi- trator an application in writing for sions of this section shall not be con- such authorization. In case two or strued to prohibit the employment of more applications for authorization to any person who has been suspended as collect a fee for the inspection of a registrant until such time as the per- brands, marks, and other identifying son demonstrates solvency or obtains characteristics of livestock are re- the bond required under the Act and ceived from the same State, a hearing regulations. No such person shall be will be held to determine which appli- employed, however, until after the ex- cant is best qualified. piration of any specified period of sus- (b) Registration and filing of schedules. pension contained in the order of sus- Upon the issuance of an authorization pension. to an agency or an association, said agency or association shall register as (7 U.S.C. 222 and 228 and 15 U.S.C. 46) a market agency in accordance with [49 FR 37374, Sept. 24, 1984] the provisions of §201.10, except that no bond need be filed or maintained, and § 201.82 Care and promptness in shall file a schedule of its rates and weighing and handling livestock charges for performing the service in and live poultry. the manner and form prescribed by (a) Each stockyard owner, market §201.17. agency, dealer, packer and live poultry (c) Reciprocal arrangements. Any au- dealer shall exercise reasonable care thorized agency or association may and promptness with respect to load- make arrangements with an associa- ing, transporting, holding, yarding, tion or associations in the same or in feeding, watering, weighing or other- another State, where branding or wise handling livestock or live poultry marking livestock prevails by custom to prevent waste of feed, shrinkage, in- or statute, to perform inspection serv- jury, death or other avoidable loss. ice at stockyards on such terms and (b) Whenever live poultry is obtained conditions as may be approved by the Administrator: Provided, That such ar- under a poultry growing arrangement, rangements will tend to further the the poultry shall be transported purpose of the Act and will not result promptly after loading and the gross in duplication of charges or services. weight for grower payment purposes (d) Maintenance of identity of consign- shall be determined immediately upon ments. All persons having custody at arrival at the processing plant, holding the stockyard of livestock subject to yard, or other scale normally used for inspection shall preserve the identity such purpose. of the consignment until inspection [54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, has been completed by the authorized 1989] inspection agency. Agencies authorized

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to conduct such inspection shall per- ination of records and inspection of fa- form the work as soon after receipt of cilities. the livestock as practicable and as rap- (Approved by the Office of Management and idly as is reasonably possible in order Budget under control number 0590–0001) to prevent delay in marketing, shrinkage in weight, or other avoidable [54 FR 16356, Apr. 24, 1989, as amended at 54 losses. FR 26349, June 23, 1989] (Approved by the Office of Management and § 201.96 Unauthorized disclosure of Budget under control number 0590–0001) business information prohibited. (7 U.S.C. 203, 204, 207, 217a, 222 and 228) No agent or employee of the United [49 FR 33005, Aug. 20, 1984] States shall, without the consent of the stockyard owner, market agency, GENERAL dealer, packer or live poultry dealer concerned, divulge or make known in § 201.94 Information as to business; any manner, any facts or information furnishing of by packers, live poultry dealers, stockyard owners, mar- regarding the business of such person ket agencies, and dealers. acquired through any examination or inspection of the business or records of Each packer, live poultry dealer, the stockyard owner, market agency, stockyard owner, market agency, and dealer, packer or live poultry dealer, or dealer, upon proper request, shall give through any information given by the to the Secretary or his duly authorized stockyard owner, market agency, deal- representatives in writing or other- er, packer, or live poultry dealer pursu- wise, and under oath or affirmation if ant to the Act and regulations, except requested by such representatives, any to such other agents or employees of information concerning the business of the United States as may be required the packer, live poultry dealer, stock- to have such knowledge in the regular yard owner, market agency, or dealer course of their official duties or except which may be required in order to insofar as they may be directed by the carry out the provisions of the Act and Administrator or by a court of com- regulations in this part within such petent jurisdiction, or except as they reasonable time as may be specified in may be otherwise required by law. the request for such information. [54 FR 16356, Apr. 24, 1989] (Approved by the Office of Management and Budget under control number 0590–0001) § 201.97 Annual reports. [54 FR 16356, Apr. 24, 1989, as amended at 54 Every packer, live poultry dealer, FR 26349, June 23, 1989] stockyard owner, market agency, and dealer (except a packer buyer reg- § 201.95 Inspection of business records and facilities. istered to purchase livestock for slaughter only) shall file annually with Each stockyard owner, market agen- the Administration a report on pre- cy, dealer, packer, and live poultry scribed forms not later than April 15 dealer, upon proper request, shall per- following the calendar year end or, if mit authorized representatives of the the records are kept on a fiscal year Secretary to enter its place of business basis, not later than 90 days after the during normal business hours and to close of his fiscal year. The Adminis- examine records pertaining to its busi- trator on good cause shown, or on his ness subject to the Act, to make copies own motion, may grant a reasonable thereof and to inspect the facilities of extension of the filing date or may such persons subject to the Act. Rea- waive the filing of such reports in par- sonable accommodations shall be made ticular cases. available to authorized representatives of the Secretary by the stockyard (Approved by the Office of Management and owner, market agency, dealer, packer, Budget under Control No. 0590–0001) or live poultry dealer for such exam- [54 FR 16356, Apr. 24, 1989]

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§ 201.98 Packers and dealers not to (d) Settlement and final payment for charge, demand, or collect commis- livestock purchased by a packer on a sion, yardage, or other service carcass weight or carcass grade and charges. weight basis shall be on actual hot No packer or dealer shall, in connec- weights. The hooks, rollers, gambrels tion with the purchase of livestock in or other similar equipment used at a commerce, charge, demand, or collect packing establishment in connection from the seller of the livestock any with the weighing of carcasses of the compensation in the form of commis- same species of livestock shall be uni- sion, yardage, or other service charge form in weight. The tare shall include unless the charge is for services man- only the weight of such equipment. dated by law or statute and is not in- (e) Settlement and final payment for consistent with the provisions of the livestock purchased by a packer on a Act. USDA carcass grade shall be on an official (final—not preliminary) grade. If [61 FR 36282, July 10, 1996] settlement and final payment are based § 201.99 Purchase of livestock by pack- upon any grades other than official ers on a carcass grade, carcass USDA grades, such other grades shall weight, or carcass grade and weight be set forth in detailed written speci- basis. fications which shall be made available (a) Each packer purchasing livestock to the seller or his duly authorized on a carcass grade, carcass weight, or agent. For purposes of settlement and carcass grade and weight basis shall, final payment for livestock purchased prior to such purchase, make known to on a grade or grade and weight basis, the seller, or to his duly authorized carcasses shall be final graded before agent, the details of the purchase con- the close of the second business day tract. Such details shall include, when following the day the livestock are applicable, expected date and place of slaughtered. slaughter, carcass price, condemnation (Approved by the Office of Management and terms, description of the carcass trim, Budget under control number 0590–0001) grading to be used, accounting, and (Pub. L. 96–511, 94 Stat. 2812 (44 U.S.C. 3501 et any special conditions. seq.); 7 U.S.C. 222 and 228 and 15 U.S.C. 46) (b) Each packer purchasing livestock on a carcass grade, carcass weight, or [33 FR 2762, Feb. 9, 1968, as amended at 33 FR 5401, Apr. 5, 1968; 49 FR 37375, Sept. 24, 1984; carcass grade and weight basis, shall 54 FR 37094, Sept. 7, 1989] maintain the identity of each seller’s livestock and the carcasses therefrom POULTRY—PACKERS AND LIVE POULTRY and shall, after determination of the DEALERS amount of the purchase price, transmit or deliver to the seller, or his duly au- § 201.100 Records to be furnished poul- thorized agent, a true written account try growers and sellers. of such purchase showing the number, (a) Contracts; contents. Each live poul- weight, and price of the carcasses of try dealer who enters into a growout each grade (identifying the grade) and (feeding) contract with a poultry grow- of the ungraded carcasses, an expla- er shall furnish the grower a true writ- nation of any condemnations, and any ten copy of the contract, which shall other information affecting final ac- clearly specify: counting. Packers purchasing livestock (1) The duration of the contract and on such a basis shall maintain suffi- conditions for the termination of the cient records to substantiate the set- contract by each of the parties; and tlement of each transaction. (2) All terms relating to the payment (c) When livestock are purchased by a to be made to the poultry grower, in- packer on a carcass weight or carcass cluding among others, where applica- grade and weight basis, purchase and ble, the following: settlement therefor shall be on the (i) The party liable for condemna- basis of carcass price. This paragraph tions, including those resulting from does not apply to purchases of live- plant errors; stock by a packer on a guaranteed (ii) The method for figuring feed con- yield basis. version ratios;

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(iii) The formula or method used to settlement. The purchase invoice shall convert condemnations to live weight; contain all information necessary to (iv) The per unit charges for feed and compute payment due the seller. When other inputs furnished by each party; U.S. Department of Agriculture con- and demnations or U.S. Department of Ag- (v) The factors to be used when riculture grades, or both, of poultry grouping or ranking poultry growers. purchased affect final payment, copies (b) Settlement sheets; contents; support- of official U.S. Department of Agri- ing documents. Each live poultry dealer, culture condemnation certificates or who acquires poultry pursuant to a grading certificates, or both, shall be contract with a poultry grower, shall furnished to the seller at or prior to prepare a true and accurate settlement the time of settlement. sheet (final accounting) and furnish a copy thereof to the poultry grower at (Approved by the Office of Management and the time of settlement. The settlement Budget under control number 0590–0001) sheet shall contain all information [54 FR 16356, Apr. 24, 1989; 54 FR 18713, May 2, necessary to compute the payment due 1989] the poultry grower. For all such arrangements in which the weight of § 201.108–1 Instructions for weighing birds affects payment, the settlement live poultry. sheet shall show, among other things, Live poultry dealers who operate the number of live birds marketed, the scales on which live poultry is weighed total weight and the average weight of for purposes of purchase, sale, acquisi- the birds, and the payment per pound. tion, or settlement are responsible for (c) Condemnation and grading certifi- the accurate weighing of such poultry. cates. Each live poultry dealer, who acquires poultry pursuant to a contract They shall supply copies of the instruc- with a poultry grower which provides tions in this section to all persons who that official U.S. Department of Agri- perform weighing operations for them culture condemnations or grades, or and direct such persons to familiarize both, are a consideration affecting pay- themselves with the instructions and ment to the grower, shall obtain an of- to comply with them at all times. This ficial U.S. Department of Agriculture section shall also apply to any addi- condemnation or grading certificate, or tional weighers who are employed at both, for the poultry and furnish a any time. Weighers must acknowledge copy thereof to the poultry grower their receipt of these instructions and prior to or at the time of settlement. agree to comply with them by signing (d) Grouping or ranking sheets. Where in duplicate, a form provided by the the contract between the live poultry Packers and Stockyards Programs, dealer and the poultry grower provides Grain Inspection, Packers and Stock- for payment to the poultry grower yards Administration. One copy of this based upon a grouping or ranking of form is to be filed with a regional of- poultry growers delivering poultry dur- fice of the Packers and Stockyards ing a specified period, the live poultry Programs, Grain Inspection, Packers dealer shall furnish the poultry grower, and Stockyards Administration and at the time of settlement, a copy of a the other copy retained by the Agency grouping or ranking sheet which shows employing the weighers. The following the grower’s precise position in the instructions shall be applicable to the grouping or ranking sheet for that pe- weighing of live poultry on all scales, riod. The grouping or ranking sheet except that paragraph (c)(1) of this sec- need not show the names of other tion is only applicable to the weighing growers, but shall show the actual fig- of live poultry on vehicle scales. ures upon which the grouping or rank- (a) Balancing the empty scale. (1) The ing is based for each grower grouped or scale shall be maintained in zero bal- ranked during the specified period. ance at all times. The empty scale (e) Live poultry purchases. Each live shall be balanced each day before poultry dealer who purchases live poul- weighing begins and thereafter its zero try shall prepare and deliver a pur- balance shall be verified before any chase invoice to the seller at time of poultry is weighed. In addition, the

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zero balance of the scale shall be veri- (b) Sensitivity control. (1) A scale must fied whenever a weigher resumes be sensitive in response to platform weighing duties after an absence from loading if it is to yield accurate the scale. weights. It, therefore, is the duty of a (2) Before balancing the empty scale, weigher to assure himself that inter- the weigher shall notify parties outside ferences, weighbeam friction, or other the scale house of his/her intention and factors do not impair sensitivity. He shall be assured that no persons or ve- shall satisfy himself, at least twice hicles are in contact with the platform. each day, that the scale is sufficiently When the empty scale is balanced and sensitive, and, if the following require- ready for weighing, the weigher shall ments are not met, he must report the so indicate by appropriate signal. facts to his superior or employer im- (3) Weighbeam scales shall be bal- mediately. anced by first seating each poise se- (2) A weighbeam scale with a balance curely in its zero notch and then mov- indicator is sufficiently sensitive if, ing the balance ball to such position when the scale is balanced with the in- that a correct zero balance is obtained. dicator at the center of the target, A scale equipped with a balance indica- movement of the fractional poise one tor is correctly balanced when the indi- graduation will change the indicator cator comes to rest in the center of the rest point (1⁄4) inch (0.25) or the width target area. A scale not equipped with of the central target area, whichever is a balance indicator is correctly bal- greater. anced if the weighbeam, when released (3) A weighbeam scale without a bal- at the top or bottom of the trig loop, ance indicator is sufficiently sensitive swings freely in the trig loop in such if, when the scale is balanced with the manner that it will come to rest at the weighbeam at the center of the trig center of the trig loop. loop, movement of the fractional poise (4) Dial scales shall be balanced by two graduations will cause the releasing all drop weights and operat- weighbeam to come to rest at the bot- ing the balance ball or other balancing tom of the trig loop. device to obtain a correct zero balance. The indicator must visibly indicate (4) Adjustable damping devices are zero on the dial reading face and the incorporated in balance indicators and ticket printer must record a correct in dial scales to absorb the effects of zero balance. ‘‘Balance tickets’’ shall load impact and to bring the indicator be filed with other scale tickets issued to rest. The weigher must be familiar on that date. with the location and adjustment of (5) Electronic digital scales should be these damping devices and keep them properly warmed up before use. In most so adjusted that when the indicator is cases it is advisable to leave the elec- displaced from a position of rest, it will tric power on continuously. The zero oscillate freely through at least one balance shall be verified by recording complete cycle of movement before the zero balance on a scale ticket. The coming to rest at its original position. main indicating element and the re- (5) Friction at weighbeam bearings mote visual weight display shall indi- may reduce the sensitiveness of the cate zero when the balance is verified. scale, cause sluggish weighbeam action The proper procedure for balancing this and affect weighing accuracy. A weigh- type of scale will vary according to the er must inspect the weighbeam assem- manufacturer. Refer to the operator’s bly daily to make certain that there is manual for specific instructions. clearance between the weighbeam and (6) A balance ball or other balancing the pivot bearings. device shall be operated only when bal- (6) Interferences or binding of the ancing the empty scale and shall not be scale platform, or other ‘‘live’’ parts of operated at any time or for any other the scale, are common causes of weigh- purpose. ing inaccuracy. A weigher shall satisfy (7) The time at which the empty himself, at the beginning of each scale is balanced or its zero balance weighing period, that all such ‘‘live’’ verified shall be marked on scale tick- parts have sufficient clearance to pre- ets or other permanent records. vent interference.

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(c) Weighing the load. (1) Vehicle that the printed weight value is suffi- scales used to weigh live poultry shall ciently distinct and legible. be of sufficient length and capacity to (2) The weight printing device on a weigh an entire vehicle as a unit; pro- scale shall be operated only to produce vided, that a trailer may be uncoupled a printed or impressed record of the from a tractor and weighed as a single weight while the load is on the scale unit. Before weighing a vehicle, either and correctly balanced. If the weight is coupled or uncoupled, the weigher shall not printed clearly and correctly, the be assured that the entire vehicle is on ticket shall be marked void and a new the scale platform and that no persons one printed before the load is removed are on the scale platform. from the scale. (i) On a weighbeam scale with a bal- (e) Weigher’s responsibilities. (1) The ance indicator the weight of a vehicle primary responsibility of a weigher is shall be determined by moving the to determine and record the true poises to such positions that the indi- weight of live poultry without preju- cator will come to rest within the dice or favor to any person or agency central target area. and without regard for poultry owner- (ii) On a weighbeam scale without a ship, price, condition, shrink, or other balance indicator the weight shall be considerations. A weigher shall not determined by moving the poises to permit the representations or attitudes such positions that the weighbeam, of any persons or agencies to influence when released from the top or bottom their judgment or action in performing of the trig loop, will swing freely in the his/her duties. trig loop and come to rest at the ap- (2) Scale tickets issued shall be seri- proximate center of the trig loop. ally numbered and used in numerical (iii) On a dial scale the weight of a sequence. Sufficient copies shall be ex- vehicle is indicated automatically ecuted to provide a copy to all parties when the indicator revolves around the to the transaction. Unused scale tick- dial face and comes to rest. ets or those which are partially exe- (iv) On an electronic digital scale the cuted shall not be left exposed or acces- weight of a vehicle is indicated auto- sible to other parties. All such tickets matically when the weight value indi- shall be kept under lock when the cated is stable. weigher is not at his duty station. (2) The correct weight is the value in (3) Accurate weighing and weight re- pounds indicated by a weighbeam, dial cording require that a weigher shall or digital scale when a stable load bal- not permit operations to be hurried to ance is obtained. In any case, the the extent that inaccurate weights or weigher should concentrate on the incorrect weight records may result. beam tip, balance indicator, dial or The gross, tare and net weights must digital indicator while weighing and be determined accurately to the near- not be concerned with reading the visi- est minimum graduation. Manual oper- ble weight indications until a stable ations connected with balancing, load balance is obtained. On electronic weighing, and recording shall be per- digital scales, the weigher should con- formed with the care necessary to pre- centrate on the pulsing or flickering of vent damage to the accurately ma- weight values to assure that the unit chined and adjusted parts of indicates a stable weight before acti- weighbeams, poises, and printing de- vating the print button. vices. Rough handling of these parts (d) Recording the weight. (1) The gross shall be avoided. or tare weight shall be recorded imme- (4) Poultry growers, live poultry diately after the load balance is ob- dealers, sellers, or others having legiti- tained and before any poises are moved mate interest in a load of poultry are or load removed from the scale plat- entitled to observe the balancing, form. The weigher shall make certain weighing, and recording procedures. A that the printed weight record agrees weigher shall not deny such persons with the weight value visibly indicated that right or withhold from them any on the weighbeam, dial or digital indi- information pertaining to the weight. cator when correct load balance is ob- The weigher shall check the zero bal- tained. The weigher shall also assure ance of the scale or reweigh a load of

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poultry when requested by such parties ing or weight recording, the weigher or duly authorized representatives of shall not use the scale until it has been the administrator. tested and inspected and found to be (f) General precautions. (1) The poises accurate. of weighbeam scales are carefully adjusted and sealed to a definite weight [37 FR 4955, Mar. 8, 1972, as amended at 61 FR 36282, July 10, 1996] at the factory and any change in that weight seriously affects weighing accu- § 201.200 Sale of livestock to a packer racy. A weigher, therefore, shall ob- on credit. serve if poise parts are broken, loose or lost or if material is added to a poise (a) No packer whose average annual and shall report any such condition to purchases of livestock exceed $500,000 his/her superior or employer. Balancing shall purchase livestock on credit, and or weighing shall not be performed no dealer or market agency acting as while a scale ticket is in the slot of a an agent for such a packer shall pur- weighbeam poise. chase livestock on credit, unless: (1) (2) Stops are provided on scale Before purchasing such livestock the weighbeams to prevent movement of packer obtains from the seller a writ- poises back of the zero graduation ten acknowledgment as follows: when balancing or weighing. When the On this date I am entering into a written stops become worn or broken and allow agreement for the sale of livestock on credit a poise to be set behind the zero posi- to ————————, a packer, and I under- tion, this condition must be reported stand that in doing so I will have no rights by the weigher to their superior or em- under the trust provisions of section 206 of ployer and corrected without delay. the Packers and Stockyards Act, 1921, as amended (7 U.S.C. 196, Pub. L. 94–410), with (3) Motion detection circuits are a respect to any such credit sale. The written part of electronic scales. They are de- agreement for such selling on credit signed to prevent the printing of weight values if the load has not sta- Covers a single sale. bilized within prescribed limits. The Provides that it will remain in effect until (date). weighmaster’s duty is to print the ac- Provides that it will remain in effect until tual weight of the load within these canceled in writing by either party. limits. This requires printing the ac- (Omit the provisions not applicable.) tual weight of the load, not one of the Date ————————————————————— other weights that may be within the Signature —————————————————— motion detection limits. (4) Foreign objects or loose material (2) Such packer retains such ac- in the form of nuts, bolts, washers, or knowledgment, together with all other other material on any part of the documents, if any, setting forth the weighbeam assembly, including the terms of such credit sales on which the counter-balance hanger or counter-bal- purchaser and seller have agreed, and ance weights, are potential sources of such dealer or market agency retains a weighing error. Loose balancing mate- copy thereof, in his records for such rial must be enclosed in the shot cup of time as is required by any law, or by the counter-balance hanger and written notice served on such person counter-balance weights must not be of by the Administrator, but not less than the slotted type which can readily be two calendar years from the date of ex- removed. piration of the written agreement re- (5) Whenever, for any reason, a ferred to in such acknowledgment; and weigher has reason to believe that a (3) Such seller receives a copy of such scale is not functioning properly or not acknowledgment. yielding correct weight values, the (b) Purchasing livestock for which weigher shall discontinue weighing, re- payment is to be made by a draft which port the facts to the parties responsible is not a check, shall constitute pur- for scale maintenance and request in- chasing such livestock on credit within spection, test or repair of the scale. the meaning of paragraph (a) of this (6) When a scale has been adjusted, section. (See also § 201.43(b)(1).) modified, or repaired in any manner (c) The provisions of this section which can affect the accuracy of weigh- shall not be construed to permit any

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transaction prohibited by § 201.61(a) re- AUTHORITY: 7 U.S.C. 228(a); 7 CFR 2.17(e), lating to financing by market agencies 2.56. selling on a commission basis. SOURCE: 43 FR 30510, July 14, 1978, unless otherwise noted. (Approved by the Office of Management and Budget under control number 0590–0001) RULES OF PRACTICE APPLICABLE TO (Sec. 401, 42 Stat. 168 (7 U.S.C. 221); sec. 409, RATE PROCEEDINGS as added by sec. 7, 90 Stat. 1250 (7 U.S.C 228b); 7 CFR 2.17, 2.54; 42 FR 35625; Pub. L. 96–511, 94 SOURCE: Sections 202.1 through 202.7 appear Stat. 2812 (44 U.S.C. 3501 et seq.); 7 U.S.C. 222 at 53 FR 51236, Dec. 21, 1988, unless otherwise and 228 and 15 U.S.C. 46) noted. [42 FR 49929, Sept. 8, 1977, as amended at 49 FR 39516, Oct. 9, 1984; 54 FR 37094, Sept. 7, § 202.1 Applicability of other rules. 1989] The Rules of Practice Governing For- mal Adjudicatory Proceedings Insti- PART 202—RULES OF PRACTICE tuted by the Secretary Under Various GOVERNING PROCEEDINGS Statutes, 7 CFR part 1, subpart H, are UNDER THE PACKERS AND applicable to all rate proceedings under STOCKYARDS ACT Sections 304, 305, 306, 307 and 310 of the Packers and Stockyards Act, 1921, as

RULES OF PRACTICE APPLICABLE TO RATE amended, 7 U.S.C. 205, 206, 207, 208 and PROCEEDINGS 211, except insofar as those Rules are in conflict with any provision herein. Sec. 202.1 Applicability of other rules. § 202.2 Definitions. 202.2 Definitions. 202.3 Institution of proceedings. As used in these rules: 202.4 Answer and reply. (a) Rate proceeding means a proceed- 202.5 Hearing. ing involving the determination and 202.6 Taking no position on the merits. prescription of any rate or charge made 202.7 Modification or vacation of final or proposed to be made for any stock- order. yard service furnished at a stockyard RULES OF PRACTICE APPLICABLE TO by a stockyard owner or market agen- REPARATION PROCEEDINGS cy, or a proceeding involving any rule, 202.101 Rule 1: Meaning of words. regulation or practice affecting any 202.102 Rule 2: Definitions. such rate or charge; and 202.103 Rule 3: Beginning a reparation pro- (b) Administrator means the Adminis- ceeding. trator of the Grain Inspection, Packers 202.104 Rule 4: Agency action. and Stockyards Administration (Pack- 202.105 Rule 5: Filing; time for filing; serv- ers and Stockyards Programs) ice. (GIPSA), or any officer or employee of 202.106 Rule 6: Answer. 202.107 Rule 7: Reply. GIPSA to whom authority has here- 202.108 Rule 8: Docketing of proceeding. tofore been delegated, or to whom au- 202.109 Rule 9: Depositions. thority may hereafter be delegated, to 202.110 Rule 10: Prehearing conference. act for the Administrator. 202.111 Rule 11: Hearing, oral or written. 202.112 Rule 12: Oral hearing. § 202.3 Institution of proceedings. 202.113 Rule 13: Written hearing. (a) Informal complaint. Any interested 202.114 Rule 14: Post-hearing procedure. 202.115 Rule 15: Submission for final consid- person desiring to complain of the law- eration. fulness of any rate or charge made or 202.116 Rule 16: Issuance of order. proposed to be made for any stockyard 202.117 Rule 17: Petition to reopen a hear- service furnished at a stockyard by a ing; to rehear or reargue a proceeding; to stockyard owner or market agency, or reconsider an order; or to set aside a de- rule, regulation or practice affecting fault order. any such rate or charge, may file an in- 202.118 Rule 18: Presiding officer. formal complaint with the Adminis- 202.119 Rule 19: Fees of witnesses. 202.120 Rule 20: Official notice. trator. 202.121 Rule 21: Intervention. (b) Investigation. If there appears to 202.122 Rule 22: Ex parte communications. be any reasonable ground for doing so, 202.123 Rule 23: Action by Secretary. the Administrator will investigate the

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matter complained of. If the Adminis- modify or vacate a final order at any trator reasonably believes that there time. Any such petition must be filed are not sufficient facts to form the with the Administrator, be based on basis for further proceeding, the mat- matters arising after the issuance of ter may be dropped. If it is dropped, the the final order, and set forth such mat- person filing the informal complaint ters, and the reasons or conditions re- will be informed. lied on, with such particularity as is (c) Status of person filing. A person fil- practicable. Any such informal petition ing an informal complaint will be a will be handled as otherwise provided party to a rate proceeding if the Ad- for an informal complaint. ministrator files such person’s infor- (b) Formal motion. A final order may mal complaint as a formal complaint, be modified or vacated at any time or if the Judge permits such person to only upon filing of a formal motion by intervene upon written application. the Administrator. Such a motion may (d) Formal complaint. A rate proceed- be filed on the initiative of the Admin- ing may be instituted only upon filing istrator, on the basis of an informal pe- of a formal complaint by the Adminis- tition, or by filing of an informal peti- trator. A formal complaint may be tion as a formal motion. filed on the initiative of the Adminis- (c) Publication. If the modification or trator, or on the basis of an informal vacation sought would involve an in- complaint, or by filing the informal crease of a rate or charge lawfully pre- complaint as a formal complaint. A scribed by the Secretary, or involve a formal complaint filed by the Adminis- rate or charge in addition to what is trator, or a summary thereof, will be specified in the final order, or involve a published in the FEDERAL REGISTER, to- regulation or practice so affecting such gether with notice of the time by a rate or charge, the formal motion, or which, and the place where, any inter- a summary thereof, will be published in ested person may file a written request the FEDERAL REGISTER, together with to be heard. notice of the place, and the time by which, any interested person may file a § 202.4 Answer and reply. written request to be heard. Respondent is not required to file an (d) Proceedings. Proceedings upon answer. If an answer is filed, complain- such a formal motion will be as other- ant is not required to file a reply. wise provided for a formal complaint.

§ 202.5 Hearing. RULES OF PRACTICE APPLICABLE TO The hearing will be oral unless all REPARATION PROCEEDINGS parties waive oral hearing. It will be § 202.101 Rule 1: Meaning of words. written if not oral. Notice of the date, time and place of oral hearing, or of In these rules, words in the singular the date and place for filing of written form shall be deemed to import the submissions in a written hearing, will plural, and vice versa, as the case may be served on the Administrator and the demand. respondent, and on such other persons as have requested in writing to be § 202.102 Rule 2: Definitions. heard. Terms defined in the Act shall mean the same in these rules as in the Act. § 202.6 Taking no position on the mer- In addition, and except as may be pro- its. vided otherwise in these rules: The proceeding may be instituted by Act means the Packers and Stock- filing of the informal complaint as a yards Act, 1921, and legislation supple- formal complaint, and the Adminis- mentary thereto and amendatory trator may take no position on the thereof, 7 U.S.C. 181 et seq.; merits of the case. Agency means those divisions and offices of the Grain Inspection, Packers § 202.7 Modification or vacation of and Stockyards Administration (Pack- final order. ers and Stockyards Programs) of the (a) Informal petition. Any interested Department which are charged with ad- person may file an informal petition to ministration of the Act;

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Agency Head means the Adminis- recommended findings of fact and con- trator, Grain Inspection, Packers and clusions with respect to all material is- Stockyards Administration (Packers sues of fact, law or discretion, as well and Stockyards Programs) of the De- as the reasons or basis therefor, and partment, or any officer or employee of order, in a reparation proceeding. the Agency to whom authority is law- Respondent means the party against fully delegated to act for the Adminis- whom a complaint is filed and repara- trator; tion is claimed, in a reparation pro- Complainant means the party who ceeding; files a complaint and claims repara- Secretary means the Secretary of Ag- tion, or on whose behalf a complaint is riculture of the United States, or any filed and reparation is claimed, in a officer or employee of the Department reparation proceeding; to whom authority is lawfully dele- Department means the United States gated to act for the Secretary; Department of Agriculture; Docketing of a reparation proceeding [43 FR 30510, July 14, 1978, as amended at 46 means transmittal of papers to the FR 60414, Dec. 10, 1981; 55 FR 41183, Oct. 10, Hearing Clerk and assignment of a 1990; 60 FR 8465, Feb. 14, 1995] docket number as provided in Rule 8, § 202.108, of these rules; § 202.103 Rule 3: Beginning a repara- Hearing means that part of a reparation proceeding. tion proceeding which involves the sub- (a) Filing. A reparation proceeding is mission of evidence for the record and begun by filing a complaint. Any inter- means either an oral or a written hear- ested person (including any agency of a ing; state or territory having jurisdiction Hearing Clerk means the Hearing over persons subject to the Act in such Clerk of the Department (see 7 CFR state or territory) desiring to complain 2.25(a)(3)); of anything done or omitted to be done Judicial Officer means the official of by any stockyard owner, market agen- the Department delegated authority by cy, or dealer in violation of sections the Secretary, pursuant to the Act of 304, 305, 306, or 307, or of an order of the April 4, 1940 (7 U.S.C. 450c–450g) and Re- Secretary made under title III, of the organization Plan No. 2 of 1953, to per- Act, may file a complaint to begin a form the function involved (see 7 CFR reparation proceeding. 2.35); (b) Form. The complaint must be in Mail means to deposit an item in the writing, state the facts of the matter United States mail with postage af- complained of, identify each person fixed and addressed as necessary to complained against (respondent), and cause it to be delivered to the address identify each person who complains shown by ordinary mail, or by certified against such respondent and claims or registered mail if specified. reparation from such respondent. It Presiding Officer means any attorney may be on a printed form supplied by who is employed in the Office of the the Agency, or may be a formal docu- General Counsel of the Department and ment, or may be a letter, mailgram, or is assigned so to act in a reparation telegram. It may be typewritten or proceeding; Re-mail means to mail by ordinary handwritten. If it is not on a printed mail to an address an item that has form supplied by the Agency, the Agen- been returned after being sent to the cy Head may, prior to docketing of the same address by certified or registered proceeding, recommend to the com- mail. plainant that an amended complaint be Reparation proceeding or Proceeding filed on such a printed form. means a proceeding under the Act be- (c) Contents and attachments. So far as fore the Secretary, in which an order practicable, the complaint should infor the payment of money is claimed clude the following items as applicable: and in which the Secretary is not a (1) Date and place where the alleged party of record; violation occurred; Report means the report to the Judi- (2) Quantity and quality of the live- cial Officer of the presiding officer’s stock involved;

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(3) Whether a sale is involved and, if (2) An amendment cannot state a new so, the date, sale price, and amount ac- and different cause of action if it is tually paid and received; filed more than 90 days after accrual of (4) Whether a consignment is in- such new and different cause of action; volved and, if so the date, reported pro- and ceeds, gross, net; (3) After the first amendment, or (5) Amount of reparation claimed, after the filing of an answer by the re- and method of computation; spondent, an amendment may not be (6) Name and address of each partner filed without the written consent of or member, if a partnership or joint the respondent, or leave of the presid- venture is involved; ing officer, or, prior to docketing of the (7) Name and address of each person proceeding, leave of the Agency Head. involved, including any agent rep- Any such amendment must be filed in resenting the complainant or the re- writing and signed by the complainant spondent in the transaction involved; or the attorney or representative of the (8) Other material facts, including complainant. If any such amendment is terms of contract; and filed before the initial service of the (9) True copies of all available papers complaint on the respondent, it shall relating to the transaction complained be served on the respondent only if the about, including shipping documents, complaint is served as provided in Rule letters, telegrams, invoices, manifests, 4(b), § 202.104(b). If any such amendment accounts of sales, and special contracts is filed after such service, it shall be or agreements, and checks and drafts. served on the respondent in any case. If it appears that any such item has (g) Withdrawal. At any time, a com- been omitted from the complaint, the plainant may withdraw a complaint Agency Head may, prior to docketing filed by or on behalf of the same com- of the proceeding, recommend to the plainant, thus terminating the repara- complainant that such item be supplied tion proceeding on such complaint un- by written amendment to the com- less a counterclaim or another complaint. plaint is pending therein. If a complainant fails to cooperate with the (d) Where to file. The complaint should be transmitted or delivered to Secretary in the disposition of the any area office of the Agency, or to the matter complained of, such complain- headquarters of the Agency in Wash- ant may be presumed to desire to with- ington, DC, or delivered to any full draw the complaint filed by or on be- time employee of the Agency. half of such complainant, after service on the parties of written notice of the (e) Time for filing. The complaint facts of such failure and reasonable op- must be received by the Department portunity for such complainant to within 90 days after accrual of the state whether such presumption is cor- cause of action alleged in it. If a com- rect. plaint is transmitted or delivered to an office of the Department, it shall be [43 FR 30510, July 14, 1978, as amended at 60 deemed to be received by the Depart- FR 8465, Feb. 14, 1995] ment when it reaches such office. If a complaint is delivered to a full time § 202.104 Rule 4: Agency action. employee of the Agency, it shall be (a) Informal disposition. If there ap- deemed to be received by the Depart- pears to be any reasonable ground for ment when it is received by such em- doing so, the Agency Head shall inves- ployee. tigate the matter complained of. If the (f) Amendment. The complaint may be Agency Head reasonably believes that amended at any time prior to the close there are not sufficient facts to form of an oral hearing or the filing of the the basis for further proceeding, the last evidence in a written hearing, ex- matter may be dropped, without preju- cept that: dice to subsequent court action on the (1) An amendment cannot add a re- same cause of action; if it is dropped, spondent if it is filed more than 90 days the person filing the complaint shall be after accrual of the cause of action informed. If the statements in the com- against such respondent; plaint, and information obtained in the

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investigation, seem to warrant such ac- of copies, except an initial complaint, tion, the Agency Head may make an ef- may be returned to the party filing it. fort to obtain the consent of the par- (b) Effective date of filing. Any docu- ties to an amicable or informal adjustment or paper other than an initial ment of the matter by communication complaint, filed in a proceeding under with the parties or their attorneys or these rules, shall be deemed to be filed representatives. Such communication at the time when it reaches the head- may be written or oral or both. quarters of the Department in Wash- (b) Service of complaint. If the matter ington DC, or, if authorized to be filed is not disposed of as provided in para- with an officer or employee of the De- graph (a), the complaint, together with partment at any place outside the Dis- any amendment which has been filed, trict of Columbia, it shall be deemed to shall be served on the respondent with be filed at the time when it reaches the a notice that an answer is required. office of such officer or employee. (c) Service of report of investigation. A (c) Additional time for filing. The time report prepared by the Agency, of its for the filing of any document or paper investigation of the matter complained other than an initial complaint, in a of, and supplements to such a report, proceeding under these rules, may upon may be served on the parties and made request be extended as reasonable, by a part of the record of the proceeding. the agency head prior to docketing of Whether such a report or supplement the proceeding, or by the presiding offi- shall be prepared, and whether it shall cer, or by the judicial officer; notice of be served on the parties and made a any extension of time shall be served part of the record, and its contents, on all parties. After docketing of the shall be in the discretion of the Agency proceeding, in all instances in which Head. The Judicial Officer shall con- time permits, notice of a request for sider information in such a report or extension of time shall be given to par- supplement as part of the evidence in ties other than the one filing such re- the proceeding, to the extent that such quest, with opportunity to submit information is relevant and material to views concerning the request. the proceeding. Any party may submit (d) Computation of time. Saturdays, evidence in rebuttal of such informa- Sundays, and Federal holidays shall be tion as is provided generally in these included in computing the time al- rules for the submission of evidence. lowed for the filing of any document or Oral testimony, to the extent credible, paper: Provided, That, when such time shall be given greater weight as evi- expires on a Saturday, Sunday, or Fed- dence than such information. eral holiday, such time shall be extended to include the next following § 202.105 Rule 5: Filing; time for filing; business day. service. (e) Who shall make service. Copies of (a) Filing; number of copies. Prior to all documents or papers required or au- docketing of a proceeding under these thorized by the rules in this part to be rules, all documents and papers other filed with the Agency shall be served than the initial complaint, filed in the on the parties by the Agency, and cop- proceeding, shall be filed with the ies of all documents or papers required Agency. After such docketing of a pro- or authorized by the rules in this part ceeding, all such documents and papers to be filed with the Hearing Clerk shall shall be filed with the hearing clerk, be served on the parties by the Hearing Provided, That all such documents and Clerk, unless any such document or papers, except a petition for disquali- paper is served by some other employee fication of a presiding officer, shall be of the Department, or by a U.S. mar- filed with the presiding officer if the shal or deputy marshal, or as otherwise parties have been served with written provided herein, or as otherwise di- notice to do so. Each such document or rected by the presiding officer or Judi- paper shall be filed in quadruplicate cial Officer. with an extra copy for each party in (f) Service on party. (1) Any complaint excess of two, except as otherwise pro- or other document initially served on a vided in these rules. Any document or person to make that person a party re- paper not filed in the required number spondent in a proceeding, a final order,

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or other document specifically ordered record of such person, or last known by the presiding officer or Judicial Of- residence of such person if an individ- ficer to be served by certified or reg- ual; istered mail, shall be deemed to be re- (2) Delivery other than by mail to ceived by any party to a proceeding on any responsible individual at, or leav- the date of delivery by certified or reg- ing in a conspicuous place at, any such istered mail to the last known prin- location; or cipal place of business of such party, (3) Delivery to such party if an indi- last known principal place of business vidual, to an officer or director of such of the attorney or representative of party if a partnership, at any location. record of such party, or last known res- (h) Proof of service. Any of the follow- idence of such party if an individual, ing, in the possession of the Depart- provided that, if any such document or ment, showing such service, shall be paper is sent by certified on registered deemed to be accurate: mail but is returned marked by the (1) A certified or registered mail re- postal service as unclaimed or refused, ceipt returned by the postal service it shall be deemed to be received by with a signature; such party on the date of remailing by (2) An official record of the postal ordinary mail to the same address. service; (2) Any document or paper, other (3) An entry on a docket record or a than one specified in paragraph (f)(1) of copy placed in a docket file by the this section or written questions for a Hearing Clerk of the Department or by deposition as provided in § 202.109(c)(3), an employee of the Hearing Clerk in shall be deemed to be received by any the ordinary course of business; party to a proceeding on the date of (4) A certificate of service, which mailing by ordinary mail to the last need not be separate from and may be known principal place of business of incorporated in the document or paper such party, last known principal place of which it certifies service, showing of business of the attorney or rep- the method, place and date of service resentative or record of such party, or in writing and signed by an individual last known residence of such party if with personal knowledge thereof, Pro- an individual. vided that such certificate must be (3) Any document or paper served verified by oath or declaration under other than by mail on any party to a penalty of perjury if the individual cer- proceeding shall be deemed to be re- tifying service is not a party to the ceived by such party on the date of: proceeding in which such document or (i) Delivery to any responsible indi- paper is served, an attorney or rep- vidual at, or leaving in a conspicuous resentative of record for such a party, place at, the last known principal place or an official or employee of the United of business of such party, last known States or of a State of political sub- principal place of business of the attor- division thereof. ney or representative of record of such party, or last known residence of such [43 FR 30510, July 14, 1978, as amended at 55 party if an individual, or FR 41183, Oct. 10, 1990; 60 FR 8465, Feb. 14, (ii) Delivery to such party if an indi- 1995] vidual, to an officer or director of such party if a corporation, or to a member § 202.106 Rule 6: Answer. of such party if a partnership, at any (a) Filing and service. Within 20 days location. after service on a respondent, of a com- (g) Service on another. Any subpoena plaint or amendment of a complaint, or other document or paper served on such person shall file an answer in any person other than a party to a pro- writing, signed by such person or by ceeding shall be deemed to be received the attorney or representative of such by such person on the date of: person. If a respondent desires an oral (1) Delivery by certified mail or reg- hearing, a request for it should be in- istered mail to the last known prin- cluded with the answer of such person. cipal place of business of such person, If any answer or amended answer is last known principal place of business filed, it shall be served on the com- of the attorney or representative of plainant.

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(b) Required contents. If a respondent made a part of the record pursuant to desires to make a defense, the answer rule 4(c), § 202.104(c), and evidence re- of such person shall contain a precise ceived in a hearing, oral or written, statement of the facts which constitute held subsequent to the expiration of the grounds of defense, and shall spe- the time for filing such answer, but cifically admit, deny, or explain each shall not be limited to such informa- of the allegations of the complaint, ex- tion and evidence. Such a respondent cept that, if the respondent is without shall not be entitled to service pro- knowledge, such answer shall state vided in these rules, of any notice or that. If a respondent does not desire to document except the final order in the make a defense, the answer of such per- proceeding. son shall contain an admission of all the allegations of the complaint, or an § 202.107 Rule 7: Reply. admission of liability to the complain- (a) Filing and service. If the answer as- ant in the full amount claimed by the serts a counterclaim or a setoff, the complainant as reparation, or both. An complainant may file a reply in writing answer may be stricken for failure to within 20 days after service of the an- comply with these requirements; no- swer on such person. If any reply or tice of an order so striking an answer amended reply is filed, it shall be shall be served on the parties; within 20 served on the respondent. days after service on a respondent of (b) Contents. The reply shall be con- such a notice, such person shall file an fined strictly to the matters alleged in answer which complies with these re- the counterclaim or setoff asserted in quirements. the answer. It shall contain a precise (c) Setoff, counterclaim or cross-claim. statement of the facts which constitute The answer may assert a setoff, coun- the grounds of defense to the counter- terclaim, or cross-claim, or any com- claim or setoff and shall specifically bination thereof. No counterclaim or admit, deny, or explain each of the al- cross-claim shall be considered unless legations of the answer constituting it is based on a violation for which the such counterclaim or setoff, except act authorizes reparation to be ordered that, if the complainant is without to be paid, and filed within 90 days knowledge, the reply shall state that. after accrual of the cause of action al- (c) Failure to file. If no reply is filed, leged therein: Provided, That a counter- the allegations of the answer shall be claim not filed within such time limit regarded as denied. may be considered if based on a transaction complained of in the complaint. [43 FR 30510, July 14, 1978, as amended at 55 Any cross-claim asserted against a co- FR 41184, Oct. 10, 1990] respondent, based on a violation for which the act authorizes reparation to § 202.108 Rule 8: Docketing of proceed- be ordered to be paid, and filed within ing. 90 days after accrual of the cause of ac- Promptly following receipt of the an- tion alleged therein, shall be served on swer, or the reply (if the answer asserts such person as a complaint; within 20 a counterclaim or a setoff), or follow- days after such service, such person ing the expiration of the period of time shall file an answer thereto in compli- prescribed above for the filing of the ance with the above requirements for answer or of the reply, the agency head an answer to a complaint. shall transmit all of the papers which (d) Failure to file. If a respondent fails have been filed in the proceeding (in- to file an answer as required above, cluding the investigation report if any such persons shall be deemed to have has been served on the parties) to the admitted all the allegations of the hearing clerk, who shall assign a dock- complaint or cross-claim against such et number to the proceeding. There- person, and to have consented to the is- after the proceeding shall be referred suance of a final order in the proceed- to by such number. The hearing clerk ing, based on all evidence in the record. shall promptly transmit all such pa- For this purpose, the evidence in the pers to the Office of the General Coun- record may include information con- sel for assignment of a presiding offi- tained in a report of investigation cer.

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§ 202.109 Rule 9: Depositions. it would constitute an undue hardship (a) Application. Any party may file an on such party to be present or rep- application for an order for the taking resented at an oral examination at of testimony by deposition, at any such place, the deposition, if taken, time after docketing of a proceeding shall be taken by means of written and before the close of an oral hearing questions. In any such case, the presid- or the filing of such party’s evidence in ing officer shall state on the record at a written hearing therein. The applica- the oral hearing that, or shall serve the tion shall set forth: (1) The name and parties with notice that, the deposi- address of the proposed deponent; (2) tion, if taken, shall be taken by means the name and address of the person (re- of written questions. ferred to in this section as the ‘‘offi- (3) If the examination is conducted cer’’) before whom the proposed exam- by means of written questions, copies ination is to be made; (3) the reasons of the applicant’s questions must be re- why such deposition should be taken, ceived by the other party to the pro- which must show that it may be able to ceeding and the officer at least 10 days be used as set forth in paragraph (i) of prior to the date set for the examina- this section; (4) whether the proposed tion unless otherwise agreed, and any examination is to be on interrogatories cross questions of a party other than or oral; and (5) if oral, a suggested time the applicant must be received by the and place where the proposed deposi- applicant and the officer at any time tion is to be made and a suggested prior to the time of the examination. manner in which the proposed deposi- (d) Order. (1) The presiding officer, if tion is to be conducted (telephone, satisfied that good cause for taking the audio-visual telecommunication, or by deposition is present, may order the personal attendance of the individuals who are expected to participate in the taking of the deposition. deposition). The application for an (2) The order shall be served on the order for the taking of testimony by parties and shall include: deposition shall be made in writing, (i) The name and address of the offi- unless it is made orally on the record cer before whom the deposition is to be at an oral hearing. made; (b) Response; service. If any such ap- (ii) The name of the deponent; plication is made orally on the record (iii) Whether the deposition will be at an oral hearing, each party other oral or on written questions; than the applicant, present at such (iv) If the deposition is oral, the man- hearing, may respond to it orally. If ner in which the deposition is to be any such application is in writing it conducted (telephone, audio-visual shall be served on each party other telecommunication, or personal at- than the applicant, and each such tendance of those who are to partici- other party shall have not less than 20 pate in the deposition); and days, from the date of service on such (v) The time, which shall not be less party of the application, to file a writ- than 20 days after the issuance of the ten response to it. order, and place. (c) Written questions (interrogatories). (1) If the examination will be oral, par- (3) The officer, time, place, and man- ties who will not be present or rep- ner of the deposition as stated in the resented at it may file written ques- presiding officer’s order need not be the tions with the officer prior to the time same as the officer, time, place, and of the examination. manner suggested in the application. (2) The presiding officer may direct, (4) The deposition shall be conducted or the parties may agree, that the dep- in the manner (telephone, audio-visual osition, if taken, shall be taken by telecommunication, or personal at- means of written questions. If the pre- tendance of those who are to partici- siding officer finds, upon the protest of pate in the deposition) agreed to by the a party to the proceeding, that such parties. party has a principal place of business (5) If the parties cannot agree on the or residence more than 100 miles from manner in which the deposition is to be the place of the examination and that conducted:

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(i) The deposition shall be conducted present at the examination; the officer by telephone unless the presiding offi- shall propound any interrogatories cer determines that conducting the filed with the officer by parties not deposition by audio-visual tele- present or represented at the examina- communication: tion. (A) Is necessary to prevent prejudice (g) Certification and filing by officer. to a party; The officer shall certify on the tran- (B) Is necessary because of a disabil- script or recording that the deponent ity of any individual expected to par- was duly sworn by the officer and that ticipate in the deposition; or the transcript or recording is a true (C) Would cost less than conducting record of the deponent’s testimony, the deposition by telephone. with such exceptions as the certificate (ii) If the deposition is not conducted shall specify. The officer shall then se- by telephone, the deposition shall be curely seal the transcript or recording, conducted by audio-visual tele- together with three copies of the tran- communication unless the presiding of- script or recording, with an extra copy ficer determines that conducting the for each party in excess of two, in an deposition by personal attendance of envelope, and mail the same by reg- any individual who is expected to par- istered or certified mail to the presid- ticipate in the deposition: ing officer. (A) Is necessary to prevent prejudice (h) Service; correction. After the tran- to a party; script or recording is received by the (B) Is necessary because of a disabil- presiding officer, it shall promptly be ity of any individual expected to par- served on all parties. Any party, within ticipate in the deposition; or 20 days after such service, may file a (C) Would cost less than conducting written motion proposing corrections the deposition by telephone or audio- to the transcript or recording. Any visual telecommunication. such motion shall be served on each (e) Qualifications of officer. No deposi- party other than the one filing it, who tion shall be made except before an of- shall have 10 days to file a written re- ficer authorized by the law of the Unit- sponse to it. Any such response shall be ed States or by the law of the place of served on each party other than the the examination to administer oaths, one filing it. Such documents, if filed, or before an officer authorized by the shall be a part of the record of the pro- Secretary to administer oaths, or be- ceeding if any portion of the transcript fore the presiding officer. No deposi- or recording is made a part of the tion shall be made before an officer record. All portions of the transcript or who is a relative (within the third de- recording which are not referred to in gree by blood or marriage), employee, any such motion shall be presumed to attorney, or representative of any be accurate except for obvious typo- party (or an employee of an attorney graphical errors. or representative of any party), or who (i) Use. If a written hearing is held, a is financially interested in the result of transcript or recording, of a deposition the proceeding. ordered and taken in accord with this (f) Procedure on examination. The de- section, may be made a part of the ponent shall be examined under oath or record as evidence by any party, by affirmation, and the testimony of the written motion filed with such party’s deponent shall be recorded by the offi- evidence. If an oral hearing is held, ex- cer, or by some person under the direc- cept as otherwise provided in these tion and in the presence of the officer. rules, such a transcript or recording If the examination is on interrog- may be made a part of the record as atories, they shall be propounded by evidence, on written motion filed by the officer. If the examination is oral, any party, or oral motion of any party the deponent shall be examined first by made at the oral hearing, if no party the party at whose instance the deposi- objects after reasonable notice and option is taken, or the representative of portunity to do so, or if the presiding such party, and shall be subject to officer finds that the evidence is other- cross-examination by any other party wise admissible and: or the representative thereof who is (1) That the witness is dead;

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(2) That the witness is unable to at- (4) The limitation of the number of tend or testify for any good reason in- expert or other witnesses; cluding age, sickness, infirmity, or im- (5) The negotiation, compromise, or prisonment; settlement of issues; (3) That the party offering the tran- (6) The exchange of copies of pro- script or recording has tried without posed exhibits; success to procure the attendance of (7) The identification of documents the witness by subpena; or or matters of which official notice may (4) That such exceptional cir- be requested; cumstances exist as to make it desirable, in the interests of justice and (8) A schedule to be followed by the with due regard to the importance of parties for completion of the actions presenting the testimony orally before decided at the conference; or the presiding officer, to allow the tran- (9) Such other matters as may expe- script or recording to be used. dite and aid in the disposition of the If any portion of a transcript or record- proceeding. ing of a deposition is made a part of No transcript or recording of such a the record as evidence on motion of conference shall be made, but the pre- any party, any other party may make siding officer shall prepare and file for a part of the record as evidence the re- the record a written summary if any mainder, or any other portion, of the action is taken at the conference, transcript or recording. which shall incorporate any written (j) Expenses. Fees and reimburse- stipulations or agreements made by ments payable to an officer taking a the parties at the conference or as a re- deposition, or other person recording sult of the conference. the testimony in the deposition, shall (b) Manner of the prehearing con- be paid by the party at whose instance ference. (1) The prehearing conference the deposition is taken. shall be conducted by telephone or cor- (k) Subpenas. No subpena can issue, respondence unless the presiding offi- to compel attendance, testimony, or cer determines that conducting the production of documentary evidence, prehearing conference by audio-visual at an examination under this rule 9. telecommunication: (l) Agreement of parties. In any case, (i) Is necessary to prevent prejudice any transcript or recording of any deposition, or any part of such a transcript to a party; or recording, may be made a part of the (ii) Is necessary because of a disabil- record as evidence by agreement of the ity of any individual expected to par- parties other than a party failing to ticipate in the prehearing conference; file an answer as required in these or rules. (iii) Would cost less than conducting the prehearing conference by telephone [43 FR 30510, July 14, 1978, as amended at 55 or correspondence. If the presiding offi- FR 41184, Oct. 10, 1990; 60 FR 8465, Feb. 14, 1995] cer determines that a prehearing conference conducted by audio-visual tele- § 202.110 Rule 10: Prehearing con- communication would measurably in- ference. crease the United States Department (a) The presiding officer, at any time of Agriculture’s cost of conducting the prior to the commencement of the prehearing conference, the prehearing hearing, may request the parties or conference shall be conducted by per- their counsel to appear at a conference sonal attendance of any individual who before the presiding officer to consider: is expected to participate in the pre- (1) The simplification of issues; hearing conference, by telephone, or by (2) The necessity of amendments to correspondence. pleadings; (2) If the prehearing conference is not (3) The possibility of obtaining stipu- conducted by telephone or correspond- lations of fact and of the authenticity, ence, the prehearing conference shall accuracy, and admissibility of docu- be conducted by audio-visual tele- ments, which will avoid unnecessary communication unless the presiding of- proof; ficer determines that conducting the

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prehearing conference by personal at- troversy. The hearing shall be written tendance of any individual who is ex- if not oral. pected to participate in the prehearing (c) Withdrawal of request. If $10,000 or conference: more is in controversy and a party has (i) Is necessary to prevent prejudice timely filed a request for oral hearing, to a party; such party may withdraw such request (ii) Is necessary because of a disabil- at any time prior to completion of an ity of any individual expected to par- oral hearing. If such a withdrawal ticipate in the prehearing conference; leaves no pending request for oral hear- or ing in the proceeding, and if the presid- (iii) Would cost less than conducting ing officer has not decided that the the prehearing conference by audio-vis- hearing should be oral, each other ual telecommunication. party shall be served with notice of [43 FR 30510, July 14, 1978, as amended at 60 this and shall be given 20 days to re- FR 8466, Feb. 14, 1995] quest an oral hearing. If any party files a request for oral hearing in such time, § 202.111 Rule 11: Hearing, oral or the hearing shall be oral in accordance written. with paragraph (b) of this section. (a) When held. A hearing, oral or (d) Presiding Officer’s recommendation. written, shall be held unless: The presiding officer may recommend (1) Each respondent admits or is voluntary withdrawal of a request for deemed to admit sufficient allegations oral hearing, timely filed. Declining to of the complaint to support the full make such withdrawal shall not affect amount claimed by the complainant as the rights or interests of any party. reparation; (e) Representation. Any party may ap- (2) Each respondent admits liability pear in an oral hearing, or file evidence to the complainant in the full amount in a written hearing, in person or by claimed by the complainant as repara- counsel or other representative. For tion; unethical or contumacious conduct in (3) Before a hearing has been com- or in connection with a proceeding, the pleted the parties agree in writing that presiding officer may preclude a person the proceeding may be decided on the from further acting as attorney or rep- basis of the record as it stands at the resentative for any party to the pro- time such agreement is filed; or ceeding; any such order of the presid- (4) Before a hearing has been coming officer shall be served on the par- pleted the parties settle their dispute ties; an appeal to the Judicial Officer or the complainant withdraws the com- may be taken from any such order im- plaint. mediately. (b) Whether oral or written. The hearing provided for in paragraph (a) of this [51 FR 42083, Nov. 21, 1986, as amended at 55 section shall be oral if: FR 41184, Oct. 10, 1990] (1) $10,000 or more is in controversy § 202.112 Rule 12: Oral hearing. and any respondent files a written request for an oral hearing with such re- (a) Time, place, and manner. (1) If and spondent’s answer; or when the proceeding has reached the (2) $10,000 or more is in controversy stage where an oral hearing is to be and any complainant files a written re- held, the presiding officer shall set a quest for an oral hearing on or before time, place, and manner for oral hear- the 20th day after service on such coming. The time shall be set based upon plainant of notice that no respondent careful consideration to the conven- has filed a timely request for an oral ience of the parties. The place shall be hearing; or set in accordance with paragraph (a)(2) (3) Less than $10,000 is in controversy of this section and careful consider- and the presiding officer determines, ation to the convenience of the parties. upon written request by any party The manner in which the hearing is to thereto, that an oral hearing is nec- be conducted shall be determined in ac- essary to establish the facts and cir- cordance with paragraphs (a)(3) and cumstances giving rise to the con- (a)(4) of this section.

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(2) The place shall be set in accord- (b) Notice. (1) A notice stating the ance with paragraphs (e) and (f) of sec- time, place, and manner of oral hearing tion 407 of the Act, if applicable. In es- shall be served on each party prior to sence, under paragraphs (e) and (f) of the time of the oral hearing. The no- section 407 of the Act, if the complain- tice shall state whether the oral hear- ant and the respondent, or all of the ing will be conducted by telephone, parties, if there are more than two, audio-visual telecommunication, or have their principal places of business personal attendance of any individual or residence within a single unit of expected to participate in the hearing. local government, a single geographi- If any change is made in the time, cal area within a State, or a single place, or manner of the oral hearing, a State, the oral hearing is to be held as notice of the change shall be served on near as possible to such places of busi- each party prior to the time of the oral ness or residence, depending on the hearing as changed, unless the change availability of an appropriate location is made during the course of an oral for conducting the hearing. If the par- hearing and shown in the transcript or ties have such places of business or res- on the recording. Any party may waive idence distant from each other, then such notice, in writing, or orally on the paragraphs (e) and (f) of section 407 of record at an oral hearing and shown in the Act are not applicable. the transcript or on the recording. (3) The oral hearing shall be con- (2) If the presiding officer orders an ducted by audio-visual telecommuni- oral hearing, any party may move that cation unless the presiding officer de- the hearing be conducted by telephone termines that conducting the oral or personal attendance of any individ- hearing by personal attendance of any ual expected to attend the hearing individual who is expected to partici- rather than by audio-visual tele- pate in the hearing: communication. Any motion that the (i) Is necessary to prevent prejudice hearing be conducted by telephone or to a party; personal attendance of any individual (ii) Is necessary because of a disabil- expected to attend the hearing must be ity of any individual expected to par- accompanied by a memorandum in sup- ticipate in the hearing; or port of the motion stating the basis for (iii) Would cost less than conducting the motion and the circumstances that the hearing by audio-visual tele- require the hearing to be conducted communication. If the presiding officer other than by audio-visual tele- determines that a hearing conducted communication. by audio-visual telecommunication (3) Within 10 days after the presiding would measurably increase the United officer issues a notice stating the man- States Department of Agriculture’s ner in which the hearing is to be con- cost of conducting the hearing, the ducted, any party may move that the hearing shall be conducted by personal presiding officer reconsider the manner attendance of any individual who is ex- in which the hearing is to be con- pected to participate in the hearing or ducted. Any motion for reconsideration by telephone. must be accompanied by a memoran- (4) The presiding officer may, in his dum in support of the motion stating or her sole discretion or in response to the basis for the motion and the cir- a motion by a party to the proceeding, cumstances that require the hearing to conduct the hearing by telephone if the be conducted other than in accordance presiding officer finds that a hearing with the presiding officer’s notice. conducted by telephone: (c) Failure to appear. If any party to (i) Would provide a full and fair evi- the proceeding, after being duly noti- dentiary hearing; fied, fails to appear at the oral hearing (ii) Would not prejudice any party; in person or by counsel or other rep- and resentative, such party shall be deemed (iii) Would cost less than conducting to have waived the right to add any the hearing by audio-visual tele- further evidence to the record in the communication or personal attendance proceeding, or to object to the admis- of any individual who is expected to sion of any evidence; if the parties who participate in the hearing. are present are all adverse to such

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party, they shall have an election to other ruling of the presiding officer, present evidence, in whole or in part, such party shall state briefly the in the form of oral testimony before grounds of such objection, and the pre- the presiding officer, affidavits, or siding officer shall rule on it. The tran- depositions. script or recording shall include argu- (d) Order of proceeding. Complainant ment or debates on objections, except shall proceed first, if present at the as ordered by the presiding officer, and commencement of the oral hearing. shall include the ruling of the presiding (e) Written statements of direct testi- officer. Objections not made before the mony. (1) Except as provided in para- presiding officer may not subsequently graph (e)(2) of this section, each party be relied on in the proceeding. must exchange with all other parties a (3) Offer of proof. Whenever evidence written narrative verified statement of is excluded by the presiding officer, the the oral direct testimony that the party offering such evidence may make party will provide at any hearing to be an offer of proof. The offer of proof conducted by telephone; the direct tes- shall consist of a brief statement, timony of each employee or agent of the party that the party will call to which shall be included in the tran- provide oral direct testimony at any script or recording, describing the evi- hearing to be conducted by telephone; dence excluded. If the evidence consists and the direct testimony of each expert of a brief oral statement, it shall be in- witness that the party will call to pro- cluded in full in the transcript or re- vide oral direct testimony at any hear- cording. If the evidence consists of an ing to be conducted by telephone. The exhibit, it shall be marked for identi- written direct testimony of witnesses fication and inserted in the record. In shall be exchanged by the parties at either such event, if the judicial officer least 10 days prior to the hearing. The decides that the presiding officer’s rul- oral direct testimony provided by a ing in excluding the evidence was erro- witness at a hearing conducted by tele- neous and prejudicial, such evidence phone will be limited to the presen- shall be considered a part of the record. tation of the written direct testimony, If the taking of such evidence will unless the presiding officer finds that consume a considerable length of time oral direct testimony which is supple- at the hearing, the presiding officer mental to the written direct testimony shall not allow the insertion of such would further the public interest and evidence in full and, if the judicial offi- would not constitute surprise. cer decides that the presiding officer’s (2) The parties shall not be required ruling in excluding the evidence was to exchange testimony in accordance erroneous and prejudicial, the hearing with this paragraph if the hearing is shall be reopened to permit the taking scheduled to begin less than 20 days of such evidence. after the presiding officer’s notice stat- (4) Depositions and affidavits. Except ing the time of the hearing. as is otherwise provided in these rules, (f) Evidence—(1) In general. The testi- admission of the deposition of any wit- mony of witnesses at an oral hearing ness shall be subject to the provisions shall be on oath or affirmation and of rule 9, § 202.109, and affidavits, and subject to cross-examination. Any witness other than a party may be exam- statements under penalty of perjury as ined separately and apart from all provided in 28 U.S.C. 1746, Pub. L. 94– other witnesses, in the discretion of 550, may be admitted only if the evi- the presiding officer. The presiding of- dence is otherwise admissible and no ficer shall exclude evidence which is party objects. immaterial, irrelevant, or unduly rep- (5) Department records. A true copy of etitious, or which is not of the sort on any written entry in any record of the which responsible persons are accus- Department, made by an officer or em- tomed to rely, insofar as practicable. ployee of the Department in the course (2) Objections. If a party objects to of the official duty of such officer or the admission of any evidence or to the employee, and relevant to the issues limitation of the scope of any examina- involved in the hearing, shall be admis- tion or cross-examination or to any sible as prima facie evidence of the

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facts stated in the record of the De- limit such argument to any extent that partment, without the production of the presiding officer finds necessary for such officer or employee. the expeditious or proper disposition of (6) Exhibits. (i) For each exhibit of- the case. fered by a party, copies in addition to (i) Transcript or recording. (1) Hearings the original shall be filed with the pre- to be conducted by telephone shall be siding officer for the use of all other recorded verbatim by electronic re- parties to the proceeding, except where cording device. Hearings conducted by the presiding officer finds that the fur- audio-visual telecommunication or the nishing of copies is impracticable. The personal attendance of any individual presiding officer shall tell the parties who is expected to participate in the the number of copies required to be hearing shall be transcribed, unless the filed, make the proper distribution of presiding officer finds that recording the copies, and have this noted on the the hearing verbatim would expedite record. the proceeding and the presiding offi- (ii) If the testimony of a witness re- cer orders the hearing to be recorded fers to any document, the presiding of- verbatim. The presiding officer shall ficer shall determine whether it shall certify that to the best of his or her be produced at the hearing and made a knowledge and belief any recording part of the record as an exhibit, or made pursuant to this paragraph with whether it shall be incorporated in the exhibits that were accepted into evi- record by reference. dence is the record of the hearing. (iii) If relevant and material matter (2) If a hearing is recorded verbatim, is embraced in a document containing a party requests the transcript of a irrelevant or immaterial matter, such hearing or part of a hearing, and the irrelevant or immaterial matter shall presiding officer determines that the be designated by the party offering the disposition of the proceeding would be document in evidence, and shall be seg- expedited by a transcript of the hear- regated and excluded, insofar as prac- ing or part of a hearing, the presiding ticable. officer shall order the verbatim tran- (g) Subpenas—(1) Issuance. The at- scription of the recording as requested tendance and testimony of witnesses by the party. and the production of documentary evi- (3) Parties to the proceeding who de- dence, from any place in the United sire copies of the transcript or record- States, on behalf of any party to the ing of the oral hearing may make ar- proceeding, may be required by sub- rangements with the reporter, who will pena at any designated place for oral furnish and deliver such copies direct hearing. Subpenas may be issued by to such parties, upon receipt from such the presiding officer, on a written ap- parties of payment for the transcript plication filed by a party, showing the or recording, at the rate provided by grounds and necessity thereof, and, the contract between the reporter and with respect to subpenas for the pro- the Department for such reporting duction of documentary evidence, service. showing their competency, relevancy, (j) Filing, and presiding officer’s certifi- and materiality and the necessity for cate, of the transcript or recording. As their production. Subpenas may be is- soon as practicable after the close of sued on the motion of the presiding of- the oral hearing, the reporter shall ficer. transmit to the presiding officer the (2) Service; proof of service. A subpena original transcript or recording of the may be served by any natural person testimony, and as many copies of the over the age of 18 years. The party at transcript or recording as may be re- whose instance a subpena is issued quired by paragraph (j) of this section shall be responsible for serving it, how- for the area offices of the Agency and ever, at the request of such party the as may be required for the Washington Secretary will attempt to serve it. office of the Agency. At the same time (h) Oral argument. The presiding offi- the reporter shall also transmit a copy cer shall permit oral argument by the of the transcript or recording to each parties or their counsel who are party who shall have arranged and paid present at an oral hearing, but may for it, as provided in paragraph (h) of

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this section. Upon receipt of the tran- § 202.113 Rule 13: Written hearing. script or recording, the presiding offi- (a) Evidence. As used in this section, cer shall attach to the original tran- the term ‘‘evidence’’ shall mean deposi- script or recording a certificate stating tions, affidavits, or statements under that, to the best of the presiding offi- penalty of perjury as provided in 28 cer’s knowledge and belief, the tran- U.S.C. 1746, Pub. L. 94–550, of persons script or recording is a true, correct, having knowledge of the facts, or docu- and complete transcript or recording of ments properly identified by such depo- the testimony given at the hearing and sition, affidavit, or statement, or oth- that the exhibits mentioned in it are erwise authenticated in such a manner all the exhibits received in evidence at that they would be admissible in evi- the hearing, with such exceptions as dence at an oral hearing, except as pro- the certificate shall specify. Such cer- vided hereinafter. Testimony on depo- tificate shall be served on each party sition, to the extent credible, shall be and a copy thereof shall be attached to given greater weight as evidence, than each copy of the transcript or record- such affidavits or statements. In a case ing received by the presiding officer. In in which a party, entitled to oral hear- accordance with such certificate the ing as provided in rule 11, § 202.111, presiding officer shall note, on the withdraws such party’s request for oral original transcript or recording, each hearing on condition that only deposi- correction detailed in such certificate tions be used if a written hearing is by adding or crossing out (but without held, only depositions, and documents obscuring the texts as orginally tran- properly identified therein, shall be scribed or recorded) at the appropriate made a part of the record as evidence places any words necessary to make by the parties if a written hearing is the text conform to the correct mean- held. ing, as certified by the presiding offi- (b) Verification. Any facts must be cer. The presiding officer shall send the verified, by oath or affirmation before copies of the transcript or recording to a person legally authorized to administer oaths or before a person des- the hearing clerk who shall send them ignated by the Secretary for the pur- to the Agency. pose (except in the case of a statement (k) Keeping of copies of the transcript under penalty of perjury as provided in or recording. During the period in which 28 U.S.C. 1746, Pub. L. 94–550), by a per- the proceeding has an active status in son who states, in the deposition, affi- the Department, a copy of the tran- davit, or statement, that such person script or recording shall be kept at the has actual knowledge of the facts. Ex- area office of the Agency most conven- cept under unusual circumstances, ient to the respondent; however, if which shall be set forth in the deposi- there are two or more respondents and tion, affidavit, or statement, any such they are located in different regions, person shall be one who would appear such copy of the transcript or record- as a witness if an oral hearing were ing shall be kept at the area office of held. the Agency nearest to the place where (c) Complainant’s evidence. The com- the hearing was held. In addition, a plainant shall be served with notice of copy of the transcript or recording an opportunity to file evidence. Within shall be kept at the area office of the 20 days after such service, the com- Agency most convenient to the complainant may file evidence. What the plainant. Any such copy shall be avail- complainant files in response to that able for examination during official notice shall be served promptly on the hours of business at the area office, but respondent. shall remain the property of the De- (d) Respondent’s evidence. After expi- partment and shall not be removed ration of the time for the filing of com- from such office. plainant’s evidence, the respondent shall be served with notice of an oppor- [43 FR 30510, July 14, 1978, as amended at 55 tunity to file evidence. Within 20 days FR 41184, Oct. 10, 1990; 60 FR 8466, Feb. 14, after such service, the respondent may 1995] file evidence. What the respondent files

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in response to that notice shall be (c) Service; delay in preparation of reserved promptly on the complainant. port. If any such document is filed by (e) Complainant’s rebuttal. If the re- any party, it shall be served on all spondent files anything pursuant to other parties. The report shall not be paragraph (d) of this section, the com- prepared before expiration of such time plainant shall be served with notice of for filing. an opportunity to file evidence in rebuttal of what the respondent has filed. [43 FR 30510, July 14, 1978, as amended at 55 Within 20 days after such service, the FR 41184, Oct. 10, 1990] complainant may file such evidence, § 202.115 Rule 15: Submission for final which shall be confined strictly to reconsideration. buttal of what the respondent has filed. What the complainant files in response (a) Report. The presiding officer, with to that notice shall be served promptly the assistance and collaboration of on the respondent. such employees of the Department as (f) Failure to file. Failure to file any may be assigned for the purpose, shall evidence authorized under this section, prepare a report. The report shall be within the time prescribed, shall con- prepared on the basis of the evidence in stitute a waiver of the right to file the record, including the investigation such evidence. report if one is prepared by the agency (g) Extension of time for depositions. If head and served on the parties, and any any party timely files an application allegations admitted or deemed to be for an order for the taking of testi- admitted, and any stipulations. The re- mony by deposition pursuant to rule 9, port shall be prepared in the form of a § 202.109, time for the filing of such par- final order for signature by the judicial ty’s evidence shall be extended as rea- officer, and shall be filed with the hear- sonable, to permit consideration of the ing clerk. The report shall not be application, and taking of depositions served on the parties unless and until if ordered. it is signed by the judicial officer. (h) Investigation report. No provision (b) Record. At the same time as the of this rule 13 shall change the status report is filed with the hearing clerk, of an investigation report served on the the record shall also be filed with the parties and made a part of the record hearing clerk. The record shall include: pursuant to rule 4, § 202.104. Pleadings; motions and requests filed [43 FR 30510, July 14, 1978, as amended at 55 and rulings thereon; the investigation FR 41184, Oct. 10, 1990] report if one is prepared by the agency head and served on the parties; the § 202.114 Rule 14: Post-hearing proce- transcript or recording of an oral hear- dure. ing, and exhibits received, if an oral (a) Oral hearing. Any party present or hearing was held; evidence filed by the represented at an oral hearing, desiring parties if a written hearing was held; to file any written argument or brief, documents filed in connection with proposed findings of fact, conclusions, pre-hearing conferences; any proposed and order, or statement of objections findings of fact, conclusions and orders, to rulings made by the presiding offi- statements of objections, and briefs; cer, must so inform the presiding offi- any stipulations; and proof of service. cer at the oral hearing; upon being so (c) Submission to judicial officer. Un- informed, the presiding officer shall set less the hearing clerk reasonably be- a reasonable time for the filing of such lieves that the record is not complete documents, and state it on the record and in proper order, the record and the at the oral hearing. report shall be submitted to the judi- (b) Written hearing. After filing of the cial officer for decision. last evidence in a written hearing, no- (d) Oral argument. There shall be no tice shall be served on each party that right to oral argument other than that such party may file, within 20 days provided in rule 12(h), § 202.112(h). after such service on such party, written argument of brief, proposed find- [43 FR 30510, July 14, 1978, as amended at 60 ings or fact, conclusions, and order. FR 8467, Feb. 14, 1995]

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§ 202.116 Rule 16: Issuance of order. on such respondent of such order. Such (a) As soon as practicable after the a petition must state a good reason receipt of the record and report from why an answer was not filed as re- the hearing clerk, the judicial officer, quired. on the basis of and after due consider- (b) Brief or memorandum of law. If ation of the record, shall issue an order such a petitioner wishes to file a brief in the proceeding, which shall be or memorandum of law in support of served on the parties. such a petition, it must be filed with (b) If the judicial officer deems it ad- such petition. visable to do so, the order may be made (c) Procedure. A presiding officer a tentative order. In such event, a pre- shall be assigned upon the filing of any siding officer shall be assigned and the such petition, or upon notice to the tentative order shall be served on each hearing clerk (which may be written or party, and each party shall have 20 oral, or by telephone) that any party days in which to file written exceptions intends to file any such petition. The to it, and arguments or briefs in sup- party filing any such petition shall be port of such exceptions. If no party referred to as the complainant or re- timely files exceptions, the tentative spondent, depending on the original order shall automatically become the designation of such party in the pro- final order in the proceeding, and no- ceeding; such party shall have the bur- tice of such fact shall be served on the den of establishing that such petition parties. If any party timely files such should be granted. If a petition to re- exceptions, they shall be handled in the open is timely filed, the order shall not same manner as a petition filed under be issued pending decision whether to rule 17, § 202.117. grant or deny the petition. If a petition to rehear or reargue or reconsider, or § 202.117 Rule 17: Petition to reopen a to set aside a default order, is timely hearing; to rehear or reargue a pro- filed, operation of the order shall be ceeding; to reconsider an order; or stayed automatically pending decision to set aside a default order. whether to grant or deny it; if such a (a) Filing of petition—(1) To reopen a petition is not timely filed, operation hearing. Any party may file a petition of the order shall not be stayed unless to reopen a hearing to take further evi- the Judicial Officer shall determine dence, at any time prior to the issu- otherwise. ance of the final order, or prior to a (d) Service; answer. No such petition tentative order becoming final. Such a shall be granted unless it, with the petition must state the nature and pur- brief or memorandum of law in support pose of the evidence to be offered, show of it, if any, is first served on each that it is not merely cumulative, and party to the proceeding other than the state a good reason why it was not of- one filing it. Each such other party, fered at the hearing if oral, or filed in within 20 days after such service on the hearing if written. such party, may file an answer to such (2) To rehear or reargue a proceeding or petition. If any such party wishes to reconsider an order. Any party may file file a brief or memorandum of law in a petition to rehear or reargue a pro- support of such an answer, it must be ceeding or reconsider an order of the filed with such answer. Any such an- judicial officer, at any time within 20 swer, with the brief or memorandum of days after service on such party of such law in support of it, if any, shall be order. Such a petition must specify the served on each party to the proceeding matters claimed to have been erro- other than the one filing it. Any such neously decided, and the basis for the petition may be denied without such petitioner’s claim that such matters service. were erroneously decided. (e) Submission for decision; service of (3) To set aside a default order. Any re- order. The presiding officer shall pre- spondent against whom an order is is- pare a recommendation with respect to sued by the judicial officer, upon fail- the petition, and submit it to the judi- ure to file an answer as required, may cial officer for decision. Such a rec- file a petition to set aside such order, ommendation shall be prepared in the at any time within 20 days after service form of a final order for signature by

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the judicial officer. It shall not be telecommunication be conducted at lo- served on the parties unless and until cations at which the parties are able to it is signed by the judicial officer. The transmit and receive documents during order of the judicial officer shall be the deposition; and served on the parties. (12) Do all acts and take all measures (f) Practice upon decision. If the judi- necessary for the maintenance of order cial officer decides to reopen a hearing, and the efficient conduct of the pro- or to rehear or permit reargument of a ceeding, including the exclusion of con- proceeding, or to set aside a default tumacious counsel or other persons. order, a presiding officer shall be as- (b) Motions and requests. The presid- signed and the rules of practice shall be ing officer is authorized to rule on all followed thereafter as applicable. motions and requests filed in the proceeding prior to submission of the pre- § 202.118 Rule 18: Presiding officer. siding officer’s report to the judicial (a) Powers. Subject to review as pro- officer, Provided, That a presiding offi- vided elsewhere in these rules, the pre- cer is not authorized to dismiss a com- siding officer assigned to any proceed- plaint. Submission or certification of ing shall have power to: any question to the judicial officer, (1) Set the time, place, and manner of prior to submission of the report, shall a prehearing conference and an oral be in the discretion of the presiding of- hearing, adjourn the oral hearing from ficer. time to time, and change the time, (c) Reassignment. For any good rea- place, and manner of oral hearing; son, including absence, illness, resigna- (2) Administer oaths and affirmation, death, or inability to act, of the tions; attorney assigned to act as a presiding (3) Issue subpenas requiring the at- officer in any proceeding under these tendance and testimony of witnesses rules, the powers and duties of such at- and the production of documentary evi- torney in the proceeding may be as- dence at an oral hearing; signed to any other attorney who is (4) Summon and examine witnesses employed in the Office of the General and receive evidence at an oral hear- Counsel of the Department, without ing; abatement of the proceeding. (5) Take or order the taking of depo- (d) Disqualification. No person shall be sitions; assigned to act as a presiding officer in (6) Admit or exclude evidence; any proceeding who (1) has any mate- (7) Hear oral argument on facts or rial pecuniary interest in any matter law; or business involved in the proceeding; (8) Require each party to provide all (2) is related within the third degree by other parties and the presiding officer blood or marriage to any party to the with a copy of any exhibit that the proceeding; or (3) has any conflict of party intends to introduce into evi- interest which might impair such per- dence prior to any oral hearing to be son’s objectivity in the proceeding. A conducted by telephone or audio-visual person assigned to act as a presiding telecommunication; officer shall ask to be replaced, in any (9) Require each party to provide all proceeding in which such person be- other parties with a copy of any docu- lieves that reason exists for disquali- ment that the party intends to use to fication of such person. examine a deponent prior to any depo- (e) Procedure on petition for disquali- sition to be conducted by telephone or fication. Any party may file a petition audio-visual telecommunication; for disqualification of the presiding of- (10) Require that any hearing to be ficer, which shall set forth with par- conducted by telephone or audio-visual ticularity the grounds of alleged dis- telecommunication be conducted at lo- qualification. Any such petition shall cations at which the parties and the be filed with the hearing clerk, who presiding officer are able to transmit shall immediately transmit it to the and receive documents during the hear- judicial officer and inform the presiding; ing officer. The record of the proceed- (11) Require that any deposition to be ing also shall immediately be trans- conducted by telephone or audio-visual mitted to the judicial officer. After

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such investigation or hearing as the ju- § 202.122 Rule 22: Ex parte commu- dicial officer deems necessary, the judi- nications. cial officer shall either deny the peti- (a) At no stage of the proceeding be- tion or direct that another presiding tween its docketing and the issuance of officer be assigned to the proceeding. the final decision shall the presiding The petition, and notice of the order of officer or judicial officer discuss ex the judicial officer, shall be made a parte the merits of the proceeding with part of the record and served on the any party, or attorney or representa- parties; if any record is made on such a tive of a party: Provided, That proce- petition, it shall be a part of the record dural matters shall not be included of the proceeding. within this limitation; and Provided [43 FR 30510, July 14, 1978, as amended at 60 further, That the presiding officer or ju- FR 8467, Feb. 14, 1995] dicial officer may discuss the merits of the case with such a person if all par- § 202.119 Rule 19: Fees of witnesses. ties to the proceeding or their attor- Witnesses subpenaed before the pre- neys or representatives have been siding officer, and witnesses whose served with notice and an opportunity depositions are taken, shall be entitled to participate. A memorandum of any to the same fees and mileage as are such discussion shall be included in the paid for like services in the courts of record. the United States. Fees and mileage (b) No party, or attorney or rep- shall be paid by the party at whose in- resentative of a party, or other person stance the witness appears or the depo- not an employee of the Department, sition is taken. shall make or knowingly cause to be made to the presiding officer or judi- § 202.120 Rule 20: Official notice. cial officer an ex parte communication Official notice shall be taken of such relevant to the merits of the proceed- matters as are judicially noticed by the ing. courts of the United States and of any (c) If the presiding officer or judicial other matter of technical or scientific officer receives an ex parte commu- fact of established character: Provided, nication in violation of this section, That the parties shall be given notice the one who receives the communica- of matters so noticed, and shall be tion shall place in the public record of given adequate opportunity to show the proceeding: that such facts are erroneously no- (1) Such communication if written, ticed. or a memorandum stating the substance of such communication if oral; § 202.121 Rule 21: Intervention. and At any time after docketing of a pro- (2) A copy of any written response or ceeding and before commencement of a a memorandum stating the substance hearing, oral or written, therein, the of any oral response thereto. presiding officer may, upon petition, (d) Copies of all such items placed or and for good cause shown, permit any included in the record, as provided in person to intervene therein. The peti- this section, shall be served on all par- tion shall state with preciseness and ties. particularity: (a) The petitioner’s rela- (e) For purposes of this section ‘‘ex tionship to the matters involved in the parte communication’’ means an oral proceeding; (b) the nature of the mate- or written communication not on the rial the petitioner intends to present in public record with respect to which evidence; (c) the nature of the argu- reasonable prior notice to all parties is ment the petitioner intends to make; not given, but it shall not include a re- and (d) the reasons why the petitioner quest for a status report on any matter should be allowed to intervene. Any or the proceeding. such petition, and notice of the order thereon, shall be served on the parties § 202.123 Rule 23: Action by Secretary. and made a part of the record in the The Secretary may act in the place proceeding. and stead of a presiding officer or the

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judicial officer in any proceeding here- yards Act have made gifts of meat to under, or any matter in connection Government employees responsible for therewith. conducting service activities of the De- partment. Such gifts have the implica- PART 203—STATEMENTS OF GEN- tions of fraud, even if not made specifi- ERAL POLICY UNDER THE PACK- cally for the purpose of influencing ERS AND STOCKYARDS ACT these employees in the performance of their duties. Sec. (b) It is a violation of the Meat In- 203.1 [Reserved] spection Act for any person, firm, or 203.2 Statement of general policy with re- corporation to give to any employee of spect to the giving by meat packers of the Department performing duties meat and other gifts to Government employees. under such act anything of value with 203.3 [Reserved] intent to influence such employee in 203.4 Statement with respect to the disposi- the discharge of his duties, or for such tion of records by packers, live poultry employee to receive from any person, dealers, stockyard owners, market agen- firm, or corporation engaged in inter- cies and dealers. state or foreign commerce any gift 203.5 Statement with respect to market given with any intent or purpose what- agencies paying the expenses of livestock buyers. soever (21 U.S.C. 90). Under the Federal 203.6 [Reserved] meat grading regulations, the giving or 203.7 Statement with respect to meat pack- attempting to give by a packer of any- er sales and purchase contracts. thing of value to any employee of the 203.8—203.9 [Reserved] Department authorized to perform any 203.10 Statement with respect to insol- function under such regulations is a vency; definition of current assets and current liabilities. basis for the withdrawal of Federal 203.11 [Reserved] meat grading service (7 CFR 53.13). The 203.12 Statement with respect to providing receiving by an employee of the De- services and facilities at stockyards on a partment of any gift from any person reasonable and nondiscriminatory basis. for whom grading, inspection, or other 203.13 [Reserved] service work is performed is specifi- 203.14 Statement with respect to advertising allowances and other merchandising cally prohibited by Departmental regu- payments and services. lations. 203.15 Trust benefits under sections 206 and (c) Upon the basis of paragraphs (a) 207 of the Act. and (b) of this section, it is the view of 203.16 Mailing of checks in payment for live- the Department that it is an unfair and stock purchased for slaughter, for cash and not on credit. deceptive practice in violation of sec- 203.17 Statement of general policy with re- tion 202(a) of the Packers and Stock- spect to rates and charges at posted yards Act (7 U.S.C. 192(a)) for any per- stockyards. son subject to the provisions of Title II 203.18 Statement with respect to packers of said Act to give or offer to give engaging in the business of custom feed- meat, money, or anything of value to ing livestock. 203.19 Statement with respect to packers any Government employee who per- engaging in the business of livestock forms inspection, grading, reporting, or dealers or buying agencies. regulatory duties directly relating to

AUTHORITY: 7 CFR 2.17(e), 2.56 the purchase or sale of livestock or the preparation or distribution of meats, § 203.1 [Reserved] meat food products, livestock products in unmanufactured form, poultry or § 203.2 Statement of general policy poultry products. with respect to the giving by meat packers of meat and other gifts to (Sec. 407, 42 Stat. 169; 7 U.S.C. 228; 9 CFR Government employees. 201.3) (a) In recent months, the Department [26 FR 710, Jan. 25, 1961; 29 FR 4081, Mar. 28, has received information, confirmed by 1964] investigation, that a number of packers subject to the Packers and Stock-

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§ 203.3 [Reserved] etc.); buying or selling pricing instructions and price lists; correspondence; § 203.4 Statement with respect to the telegrams; teletype communications disposition of records by packers, and memoranda relating to matters live poultry dealers, stockyard own- other than contracts, agreements, pur- ers, market agencies and dealers. chase or sales invoices, or claims or (a) Records to be kept. Section 401 of credit memoranda; and Provided fur- the Packers and Stockyards Act (7 ther, That microfilm copies of records U.S.C. 221) provides, in part, that every may be substituted for and retained in packer, live poultry dealer, stockyard lieu of the actual records. owner, market agency, and dealer shall (c) Retention for longer periods may be keep such accounts, records, and required. The periods specified in para- memoranda as fully and correctly dis- graph (b) of this section shall be ex- close all transactions involved in his tended if the packer, live poultry deal- business, including the true ownership er, stockyard owner, market agency, or of such business by stockholding or dealer is notified in writing by the Ad- otherwise. In order to properly admin- ministrator that specified records ister the P&S Act, it is necessary that should be retained for a longer period records be retained for such periods of pending the completion of any inves- time as may be required to permit the tigation or proceedings under the Act. Grain Inspection, Packers and Stock- (d) Unauthorized disposal of records. If yards Administration (Packers and it is found that any person subject to Stockyards Programs) a reasonable op- the Act has disposed of accounts, portunity to examine such records. records, and memoranda which are nec- Section 401 of the Act does not, how- essary to fully and correctly disclose ever, provide for the destruction or dis- all transactions in its business prior to posal of records. Therefore, the Grain the periods specified in this statement, Inspection, Packers and Stockyards consideration will be given to the issu- Administration (Packers and Stock- ance of a complaint charging a viola- yards Programs) has formulated this tion of section 401 of the Act and seek- policy statement to provide guidance ing an appropriate order. The adminis- as to the periods of time after which trative proceeding initiated will be records may be disposed of or de- conducted in accordance with the stroyed. Rules of Practice Governing Formal (b) Records may be disposed of after two Adjudicatory Proceedings Instituted by years except as otherwise provided. Ex- the Secretary (7 CFR 1.130 et seq.). cept as provided in paragraph (c) of (Approved by the Office of Management and this section, each packer, live poultry Budget under control number 0590–0001) dealer, stockyard owner, market agen- (7 U.S.C. 228, 7 U.S.C. 222, and 15 U.S.C. 46) cy, and dealer may destroy or dispose [49 FR 6085, Feb. 17, 1984, as amended at 54 of accounts, records, and memoranda FR 16357, Apr. 24, 1989] which contain, explain, or modify transactions in its business subject to § 203.5 Statement with respect to mar- the Act after such accounts, records, ket agencies paying the expenses of and memoranda have been retained for livestock buyers. a period of two full years; Provided, It has become a practice in certain That the following records made or areas of the country for market agen- kept by a packer may be disposed of cies, engaged in the business of selling after one year: cutting tests; depart- consigned livestock on a commission mental transfers; buyers’ estimates; basis, to pay certain of the business or drive sheets; scale tickets received personal expenses incurred by buyers from others; inventory and products in attending livestock sales conducted by storage; receiving records; trial bal- such market agencies, such as, ex- ances; departmental overhead or expenses for meals, lodging, travel, enter- pense recapitulations; bank state- tainment and long distance telephone ments, reconciliations and deposit calls. Investigation by the Grain In- slips; production or sale tonnage re- spection, Packers and Stockyards Ad- ports (including recapitulations and ministration (Packers and Stockyards summaries of routes, branches, plants, Programs), discloses that this practice

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tends to become a method of competi- putes concerning condition, grade, tion between similarly engaged market weight, or shipping instructions. agencies and results in undue and un- (b) It is believed that both seller and reasonable cost burdens on such mar- buyer should take the following points ket agencies and the livestock produc- into consideration when selling and ers who sell their livestock through buying meat and meat food products: such market agencies. (1) Terms of shipment and time of arriv- It is the view of the Grain Inspection, al. Terms and conditions of shipment Packers and Stockyards Administra- and delivery should be specified in the tion (Packers and Stockyards Pro- contract and both parties should un- grams) that it constitutes violations of derstand fully all terms and conditions the Packers and Stockyards Act, 1921, of the contract. Any deviation from as amended (7 U.S.C. 181 et seq.), for normal practices, such as a guaranty any market agency engaged in the by the shipper as to the date of arrival business of selling consigned livestock at destination, or a deviation from the on a commission basis, to pay, directly normal meaning of terms, should also or indirectly, any personal or business be fully understood and made a part of expenses of livestock buyers attending the contract. sales conducted by such market agen- (2) Quality and condition. (i) A seller cy. In the future, if any market agency has the responsibility of making cer- engages in such practice, consideration tain that the meat and meat food prod- will be given by the Grain Inspection, ucts shipped are in accordance with the Packers and Stockyards Administra- terms of the contract specifications. tion (Packers and Stockyards Pro- (ii) When a buyer believes that the grams) to the issuance of a complaint shipment does not meet the terms of charging the market agency with vio- the contract, he should immediately lation of the Act. In the formal admin- contact the seller or the seller’s agent istrative proceeding initiated by any and advise him of the nature of the such complaint, the Judicial Officer of complaint. This affords the seller an the Department will determine, after opportunity to renegotiate the con- full hearing, whether the market agen- tract, to personally inspect the meat or meat food products, or to have an im- cy has violated the Act and should be partial party inspect or examine the ordered to cease and desist from con- meat or meat food products. Inspection tinuing such violation, and whether and examination service of this type is the registration of such market agency available nationally through the USDA should be suspended for a reasonable meat grading service and locally period of time. through various impartial persons or (Secs. 407, 4, 42 Stat. 169, 72 Stat. 1750; 7 agencies. U.S.C. 228. Interprets or applies secs. 304, 307, (iii) All terms of a transaction should 312, 42 Stat. 164, 165, 167; 7 U.S.C. 205, 208, 213) be made clear in the contract, whether [29 FR 311, Jan. 14, 1964; 29 FR 3304, Mar. 12, written or verbal. If there is any 1964, as amended at 32 FR 7700, May 26, 1967] chance of misunderstanding, a written confirmation should be exchanged be- § 203.6 [Reserved] tween the parties. In any case where a contract dispute cannot be settled be- § 203.7 Statement with respect to meat tween the parties and either party in- packer sales and purchase con- tends to file a complaint, such com- tracts. plaint should be brought to the atten- (a) The Grain Inspection, Packers tion of the nearest Grain Inspection, and Stockyards Administration (Pack- Packers and Stockyards Administra- ers and Stockyards Programs) receives tion (Packers and Stockyards Pro- numerous complaints concerning the grams) area office as soon as possible. failure or refusal of buyers to pay the However, a concerted effort on the part full purchase price for, or to accept de- of both buyer and seller to negotiate livery of, their purchases of meat and clear and complete contracts will meat food products and sellers failing greatly reduce misunderstandings to meet contractual specifications. which can result in the filing of com- Most such complaints arise out of dis- plaints with the Administration.

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(c) If the Grain Inspection, Packers resources principally classifiable as and Stockyards Administration (Pack- current assets or the creation of other ers and Stockyards Programs) has rea- current liabilities during the one year son to believe that any packer operating cycle of the business. unjustifiably (1) has refused to pay the (c) The term current assets generally contractual price for meat or meat includes: (1) Cash in bank or on hand; food products purchased, (2) has refused (2) sums due a market agency from a to accept a shipment of meat or meat custodial account for shippers’ pro- food products, or (3) has failed to ship ceeds; (3) accounts receivable, if col- meat or meat food products in accord- lectable; (4) notes receivable and por- ance with the terms of the contract tions of long-term notes receivable specifications, consideration will be within one year from date of balance given to the issuance of a complaint sheet, if collectable; (5) inventories of charging the packer with violation of livestock acquired for purposes of re- section 202 of the Act. In the formal ad- sale or for purposes of market support; ministrative proceeding initiated by (6) feed inventories and other inven- any such complaint, the Judicial Offi- tories which are intended to be sold or cer of the Department will determine, consumed in the normal operating upon the basis of the record in the pro- cycle of the business; (7) accounts due ceeding, whether the packer has vio- from employees, if collectable; (8) ac- lated the Act and should be ordered to counts due from officers of a corpora- cease and desist from continuing such tion, if collectable; (9) accounts due violation. from affiliates and subsidiaries of corporations if the financial position of (Secs. 407(a), 4, 42 Stat. 169, 72 Stat. 1750; 7 U.S.C. 228(a). Interprets or applies sec. 202, 42 such subsidiaries and affiliates justifies Stat. 161 et seq., as amended; 7 U.S.C. 192) such classification; (10) marketable se- [30 FR 14966, Dec. 3, 1965, as amended at 32 curities representing cash available for FR 7701, May 26, 1967] current operations and not otherwise pledged as security; (11) accured inter- §§ 203.8—203.9 [Reserved] est receivable; and (12) prepaid expenses. § 203.10 Statement with respect to in- (d) The term current assets generally solvency; definition of current as- excludes: (1) Cash and claims to cash sets and current liabilities. which are restricted as to withdrawal, (a) Under the Packers and Stock- such as custodial funds for shippers’ yards Act, 1921, as amended and supple- proceeds and current proceeds receiv- mented (7 U.S.C. 181 et seq.), the prin- able from the sale of livestock sold on cipal test of insolvency is to determine a commission basis; (2) investments in whether a person’s current liabilities securities (whether marketable or not) exceed his current assets. This current or advances which have been made for ratio test of insolvency under the Act the purposes of control, affiliation, or has been reviewed and affirmed by a other continuing business advantage; United States Court of Appeals. Bow- (3) receivables which are not expected man v. United States Department of Agri- to be collected within 12 months; (4) culture, 363 F. 2d 81 (5th Cir. 1966). cash surrender value of life insurance (b) For the purposes of the adminis- policies; (5) land and other natural re- tration of the Packers and Stockyards sources; and (6) depreciable assets. Act, 1921, the following terms shall be (e) The term current liabilities gen- construed, respectively, to mean: erally includes: (1) Bank overdrafts (1) Current assets means cash and (per books); (2) amounts due a custo- other assets or resources commonly dial account for shippers’ proceeds; (3) identified as those which are reason- accounts payable within one year from ably expected to be realized in cash or date of balance sheet; (4) notes payable sold or consumed during the normal or portions thereof due and payable operating cycle of the business, which within one year from date of balance is considered to be one year. sheet; (5) accruals such as taxes, wages, (2) Current liabilities means obliga- social security, unemployment com- tions whose liquidation is reasonably pensation, etc., due and payable as of expected to require the use of existing the date of the balance sheet; and (6)

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all other liabilities whose regular and mission basis or otherwise, marketing, ordinary liquidation is expected to feeding, watering, holding, delivery, occur within one year. shipment, weighing, or handling, in commerce, of livestock.’’ (Sec. 407(a), 42 Stat. 169, 72 Stat. 1750; 7 (f) It is the view of the Grain Inspec- U.S.C. 228(a). Interprets or applies secs. 202, 307, 312, 502, 505; 42 Stat. 161 et seq., as tion, Packers and Stockyards Adminis- amended; 7 U.S.C. 192, 208, 213, 218a, 218d) tration (Packers and Stockyards Pro- [32 FR 6901, May 5, 1967] grams) that it is a violation of sections 304, 307, and 312(a) of the Act for a § 203.11 [Reserved] stockyard owner or market agency to discriminate, in the furnishing of § 203.12 Statement with respect to pro- stockyard services or facilities or in es- viding services and facilities at tablishing rules or regulations at the stockyards on a reasonable and stockyard, because of race, religion, nondiscriminatory basis. color, or national origin of those per- (a) Section 304 of the Packers and sons using the stockyard services or fa- Stockyards Act (7 U.S.C. 205) provides cilities. Such services and facilities in- that: ‘‘All stockyard services furnished clude, but are not limited to, the res- pursuant to reasonable request made to taurant, restrooms, drinking fountains, a stockyard owner or market agency at lounge accommodations, those fur- such stockyard shall be reasonable and nished for the selling, weighing, or nondiscriminatory and stockyard serv- other handling of the livestock, and fa- ices which are furnished shall not be cilities for observing such services. refused on any basis that is un- (g) If the Grain Inspection, Packers reasonable or unjustly discriminatory and Stockyards Administration (Pack- * * *.’’ ers and Stockyards Programs) has rea- (b) Section 305 of the Act (7 U.S.C. son to believe that any stockyard 206) states that: ‘‘All rates or charges owner or market agency has so dis- made for any stockyard services fur- criminated in the furnishing of stock- nished at a stockyard by a stockyard yard services or facilities, consider- owner or market agency shall be just, ation will be given to the issuance of a reasonable, and nondiscriminatory complaint charging the stockyard or * * *.’’ market agency with violations of the (c) Section 307 (7 U.S.C. 208) provides Act. that: ‘‘It shall be the duty of every (Sec. 407(a), 42 Stat. 159, 72 Stat. 1750; 7 stockyard owner and market agency to U.S.C. 228(a). Interprets or applies secs. 304, establish, observe, and enforce just, 307, 312, 42 Stat. 161 et seq., as amended, 7 reasonable, and nondiscriminatory reg- U.S.C. 205, 208, 213) ulations and practices in respect to the [33 FR 17621, Nov. 26, 1968] furnishing of stockyard services * * *.’’ (d) Section 312(a) (7 U.S.C. 213(a)) pro- § 203.13 [Reserved] vides that: ‘‘It shall be unlawful for § 203.14 Statement with respect to ad- any stockyard owner, market agency, vertising allowances and other mer- or dealer to engage in or use any un- chandising payments and services. fair, unjustly discriminatory, or deceptive practice or device in connection The Guidelines with determining whether persons 1. Who is a customer? (a) A customer is a per- should be authorized to operate at the son who buys for resale directly from the stockyards, or with the receiving, mar- packer, or through the packer’s agent or keting, buying, or selling on a commis- broker; and in addition, a customer is any sion basis or otherwise, feeding, water- buyer of the packer’s product for resale who ing, holding, delivery, shipment, weigh- purchases from or through a wholesaler or other intermediate reseller. ing or handling, in commerce, of livestock.’’ (NOTE: In determining whether a packer (e) Section 301(b) (7 U.S.C. 201(b)) de- has fulfilled its obligations toward its customers, the Grain Inspection, Packers and fines ‘‘stockyard services’’ as any Stockyards Administration (Packers and ‘‘services or facilities furnished at a Stockyards Programs) will recognize that stockyard in connection with the re- there may be some exceptions to this general ceiving, buying, or selling on a com- definition of ‘‘customer.’’ For example, the

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purchaser of distress merchandise would not of the dollar volume of such purchases dur- be considered a ‘‘customer’’ simply on the ing a specified time. basis of such purchase. Similarly, a retailer Example 2: A packer may properly place in who purchases solely from other retailers or reserve for each customer a specified amount one who makes only sporadic purchases, or of money for each unit purchased and use it one who does not regularly sell the packer’s to reimburse those customers for the cost of product or who is a type of retail outlet not advertising and promoting the packer’s prod- usually selling such products will not be con- uct during a specified time. sidered a ‘‘customer’’ of the packer unless Example 3: A packer’s plan should not pro- the packer has been put on notice that such vide an allowance on a basis that has rates retailer is selling its product.) graduated with the amount of goods purchased, as for instance, 1 percent of the first (b) Competing customers are all businesses $1,000 purchases per month, 2 percent on sec- that compete in the resale of the packer’s ond $1,000 per month, and 3 percent on all products of like grade and quality at the over that. same functional level of distribution, regard- (b) Packer’s duty to inform—The packer less of whether they purchase direct from should take reasonable action, in good faith, the packer or through some intermediary. to inform all its competing customers of the Example: A packer sells directly to some availability of its promotional program. independent retailers, sells to the head- Such notification should include all the rel- quarters of chains and of retailer-owned co- evant details of the offer in time to enable operatives, and also sells to wholesalers. The customers to make an informed judgment direct-buying independent retailers, the whether to participate. Where such one-step headquarters of chains and of retailer-owned notification is impracticable, the packer cooperatives, and the wholesalers’ independ- may, in lieu thereof, maintain a continuing ent retailer customers are customers of the program of first notifying all competing cus- packer. Individual retail outlets which are tomers of the types of promotions offered by part of the chains or members of the re- the packer and a specific source for the cus- tailer-owned cooperatives are not customers tomer to contact in order to receive full and of the packer. timely notice of all relevant details of the 2. Definition of services. Services are any packer’s promotions. Such notice should also kind of advertising or promotion of a pack- inform all competing customers that the er’s product, including but not limited to, packer offers advertising allowances and/or cooperative advertising, handbills, window other promotional assistance that are usable and floor displays, demonstrators and dem- in a practical business sense by all retailers onstrations, customer coupons, and point of regardless of size. When a customer indicates purchase activity. its desire to be put on the notification list, the packer should keep that customer ad- 3. Need for a plan. If a packer makes pay- vised of all promotions available in its area ments or furnishes services, it should do so as long as the customer so desires. The pack- under a plan that meets several require- er may make the required notification by ments. If there are many competing cus- any means it chooses; but in order to show tomers to be considered, or if the plan is at later that it gave notice to a certain cus- all complex, the packer would be well ad- tomer, it is in a better position to do so if it vised to put its plan in writing. The require- was given in writing or a record was pre- ments are: pared at the time of notification showing (a) Proportionally equal terms—The pay- date, person notified, and contents of notifi- ments or services under the plan should be cation. made available to all competing customers If more direct methods of notification are on proportionally equal terms. This means impracticable, a packer may employ one or that payments or services should be made more of the following methods, the suffi- proportionately on some basis that is fair to ciency of which will depend upon the com- all customers who compete in the resale of plexity of its own distribution system. Dif- the packer’s products. No single way to ferent packers may find that different notifi- achieve the proper proportion is prescribed, cation methods are most effective for them: and any method that treats competing cus- (1) The packer may enter into contracts tomers on proportionally equal terms may with its wholesaler, distributors or other be used. Generally, this can best be done by third parties which conform to the require- basing the payments made or the services ments of item 5, infra. furnished on the dollar volume or on the (2) The packer may place appropriate an- quantity of goods purchased during a speci- nouncements on product containers or inside fied period. Other methods which are fair to thereof with conspicuous notice of such en- all competing customers are also acceptable. closure on the outside. Example 1: A packer may properly offer to (3) The packer may publish notice of the pay a specified part (say 50 percent) of the availability and essential features of a pro- cost of local advertising up to an amount motional plan in a publication of general dis- equal to a set percentage (such as 5 percent) tribution in the trade.

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Example 1: A packer has a wholesaler-ori- When a packer, in good faith, offers a basic ented plan directed to wholesalers distribut- plan, including alternatives, which is reason- ing its products to retailing customers. It ably fair and nondiscriminatory and refrains should notify all the competing wholesalers from taking any steps which would prevent distributing its products of the availability any customer, or class of customers, from of this plan, but the packer is not required to participating in its program, it shall be notify retailing customers. deemed to have satisfied its obligation to Example 2: A packer who sells on a direct make its plan functionally available to all basis to some retailers in an area, and to customers, and the failure of any customer other retailers in the area through wholesalers, has a plan for the promotion of its or customers to participate in the program products at the retail level. If the packer di- shall not be deemed to place the packer in rectly notifies not only all competing direct violation of the provisions of the Packers purchasing retailers but also all competing and Stockyards Act. retailers purchasing through the wholesalers Example 1: A packer offers a plan of short as to the availability, terms and conditions term store displays of varying sizes, includ- of the plan, the packer is not required to no- ing some which are suitable for each of its tify its wholesalers. competing customers and at the same time Example 3: A packer regularly engages in are small enough so that each customer may promotional programs and the competing make use of the promotion in a practical customers include large direct purchasing business sense. The plan also calls for uni- retailers and smaller customers who pur- form, reasonable certification of perform- chase through wholesalers. The packer may ance by the retailer. Because they are reluc- encourage, but not coerce, the retailer pur- tant to process a reasonable amount of pa- chasing through a wholesaler to designate a perwork, some small retailers do not partici- wholesaler as its agent for receiving notice of, collecting, and using promotional allow- pate. This fact is not deemed to place a pack- ances for the customer. If a wholesaler or er in violation of Item 3(c) and it is under no other intermediary by written agreement obligation to provide additional alternatives. with a retailer is actually authorized to col- Example 2: A packer offers a plan for coop- lect promotional payments from suppliers, erative advertising on radio, television, or in the packer may assume that notice of and newspapers of general circulation.1 Because payment under a promotional plan to such the purchases of some of its customers are wholesaler or intermediary constitutes no- too small, this offer is not ‘‘functionally tice and payment to the retailer. available’’ to them. The packer should offer (A packer should not rely on a written them alternative(s) on proportionally equal agreement authorizing an intermediary to terms that are usable by them and suitable receive notice of and/or payment under a for their business. promotional plan for a retailer if the packer (d) Need to understand terms—In inform- knows, or should know, that the retailer was ing customers of the details of a plan, the coerced into signing the agreement. In addition, a packer should assume that an packer should provide them sufficient infor- intermediary is not authorized to receive no- mation to give a clear understanding of the tice of and/or payment under a promotional exact terms of the offer, including all alter- plan for a retailer unless there is a written natives, and the conditions upon which pay- authorization signed by such retailer.) ment will be made or services furnished. (c) Availability to all competing cus- (e) Checking customer’s use of payments— tomers—The plan should be such that all The packer should take reasonable pre- types of competing customers may partici- cautions to see that services it is paying for pate. It should not be tailored to favor or are furnished and also that it is not overpay- discriminate against a particular customer ing for them. Moreover, the customer should or class of customers but should, in its expend the allowance solely for the purpose terms, be usable in a practical business sense for which it was given. If the packer knows by all competing customers. This may re- or should know that what it pays or fur- quire offering all such customers more than nishes is not being properly used by some one way to participate in the plan or offering alternative terms and conditions to customers for whom the basic plan is not usable 1 In order to avoid the tailoring of pro- and suitable. The packer should not, either motional programs that discriminate against expressly or by the way the plan operates, particular customers or class of customers, eliminate some competing customers, al- the packer in offering to pay allowances for though it may offer alternative plans de- newspaper advertising should offer to pay signed for different customer classes. If it of- the same percentage of the cost of newspaper fers alternative plans, all of the plans offered advertising for all competing customers in a should provide the same proportionate equal- newspaper of the customer’s choice, or at ity and the packer should inform competing least in those newspapers that meet the re- customers of the various alternative plans. quirements for second class mail privileges.

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customers, the improper payments or serv- any such agreement provisions that the ices should be discontinued.2 intermediary will: A packer who, in good faith, takes reason- (1) Give notice to the packer’s customers able and prudent measures to verify the per- in conformity with the standards set forth in formance of its competing customers will be items 3(b) and (d), supra; deemed to have satisfied its obligations (2) Check customer performance in con- under the Act. Also, a packer who, in good formity with the standards set forth in item faith, concludes a promotional agreement 3(e), supra; with wholesalers or other intermediaries and (3) Implement the plan in a manner which who otherwise conforms to the standards of will insure its functional availability to the Item 5 shall be deemed to have satisfied this packer’s customers in conformity with the obligation. If a packer has taken such steps, standards set forth in item 3(c), supra (This the fact that a particular customer has re- must be done whether the plan is one devised tained an allowance in excess of the cost, or by the packer itself or by the intermediary approximate cost if the actual cost is not for use by the packer’s customers.); and known, of services performed by the cus- (4) Provide certification in writing and at tomer shall not alone be deemed to place a reasonable intervals that the packer’s cus- packer in violation of the Act. tomers have been and are being treated in (When customers may have different but conformity with the agreement. closely related costs in furnishing services A packer who negotiates such agreements that are difficult to determine such as the with its wholesalers, distributors or third cost for distributing coupons from a bulletin party promoters will be considered by the board or using a window banner, the packer Administration to have justified its ‘‘good may furnish to each customer the same pay- faith’’ obligations under this section only if ment if it has a reasonable relationship to it accompanies such agreements with the fol- the cost of providing the service or is not lowing supplementary measures: At regular grossly in excess thereof.) intervals the packer takes affirmative steps 4. Competing customers. The packer is re- to verify that its customers are receiving the quired to provide in its plan only for those proportionally equal treatment to which customers who compete with each other in they are entitled by making spot checks de- the resale of the packer’s products of like signed to reach a representative cross section of its customers. Whenever such spot grade and quality. Therefore a packer should checks indicate that the agreements are not make available to all competing wholesalers being implemented in such a way that its any plan providing promotional payments or customers are receiving such proportionally services to wholesalers, and similarly should equal treatment, the packer takes imme- make available to all competing retailers diate steps to expand or to supplement such any plan providing promotional payments or agreements in a manner reasonably designed services to retailers. With these require- to eliminate the repetition or continuation ments met, a packer can limit the area of its of any such discriminations in the future. promotion. However, this section is not in- Intermediaries, subject to the Packers and tended to deal with the question of a pack- Stockyards Act, administering promotional er’s liability for use of an area promotion assistance programs on behalf of a packer where the effect may be to injure the pack- may be in violation of the provisions of the er’s competition. Packers and Stockyards Act, if they have 5. Wholesaler or third party performance of agreed to perform the packer’s obligations packer’s obligations. A packer may, in good under the Act with respect to a program faith, enter into written agreements with which they have represented to be usable and intermediaries, such as wholesalers, distribu- suitable for all the packer’s competing cus- tors or other third parties, including promot- tomers if it should later develop that the ers of tripartite promotional plans, which program was not offered to all or, if offered, provide that such intermediaries will per- was not usable or suitable, or was otherwise form all or part of the packer’s obligations administered in a discriminatory manner. under this part. However, the interposition 6. Customer’s liability. A customer, subject of intermediaries between the packer and its to the Packers and Stockyards Act, who customers does not relieve the packer of its knows, or should know, that it is receiving ultimate responsibility of compliance with payments or services which are not available the provisions of the Packers and Stock- on proportionally equal terms to its com- yards Act. The packer, in order to dem- petitors engaged in the resale of the same onstrate its good faith effort to discharge its packer’s products may be in violation of the obligations under this part, should include in provisions of the Act. Also, customers (subject to the Packers and Stockyards Act) that 2 The granting of allowances or payments make unauthorized deductions from pur- that have little or no relationship to cost or chase invoices for alleged advertising or approximate cost of the service provided by other promotional allowances may be pro- the retailer may be considered a violation of ceeded against under the provisions of the section 202 of the Act. Act.

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Example: A customer subject to the Act (6) Amount of money due; and to should not induce or receive an allowance in make certain that a copy of such let- excess of that offered in the packer’s adver- ter, mailgram, or telegram is filed with tising plan by billing the packer at ‘‘vendor a GIPSA Regional Office or with rates’’ or for any other amount in excess of that authorized in the packer’s promotion GIPSA, USDA, Washington, DC 20250, program. within the prescribed time. 7. Meeting competition. A packer charged (b) While the above information is with discrimination under the provisions of desirable, any written notice which in- the Packers and Stockyards Act may defend forms the packer or live poultry dealer its actions by showing that the payments and the Secretary that the packer or were made or the services were furnished in live poultry dealer has failed to pay is good faith to meet equally high payments sufficient to meet the above-mentioned made by a competing packer to the particu- statutory requirement if it is given lar customer, or to meet equivalent services furnished by a competing packer to the par- within the prescribed time. ticular customer. This defense, however, is subject to important limitations. For in- (Approved by the Office of Management and stance, it is insufficient to defend solely on Budget under control number 0590–0001) the basis that competition in a particular [54 FR 16357, Apr. 24, 1989] market is very keen, requiring that special allowances be given to some customers if a § 203.16 Mailing of checks in payment packer is ‘‘to be competitive.’’ for livestock purchased for slaugh- 8. Cost justification. It is no defense to a ter, for cash and not on credit. charge of unlawful discrimination in the (a) The Grain Inspection, Packers payment of an allowance or the furnishing of and Stockyards Administration (Pack- a service for a packer to show that such payment or service could be justified through ers and Stockyards Programs) recog- savings in the cost of manufacture, sale, or nizes that one who sells livestock to a delivery. packer, market agency, or dealer, who is purchasing for slaughter, may not (Approved by the Office of Management and Budget under control number 0590–0001) intend to be present at the point of transfer of possession of the livestock, [58 FR 52886, Oct. 13, 1993; 58 FR 58902, Nov. 4, to receive payment, at the time a 1993] check in payment for such livestock § 203.15 Trust benefits under sections may be delivered by the purchaser, and 206 and 207 of the Act. may not wish to authorize a representative to receive such a check; or for (a) Within the times specified under other reasons such a seller may prefer sections 206(b) and 207(d) of the Act, that such a purchaser make payment any livestock seller, live poultry seller by mailing a check within the time or grower, to preserve his interest in limit as prescribed in section 409(a) of the statutory trust, must give written the Act. In cases when the seller does notice to the appropriate packer or live not intend to be present, he may use poultry dealer and file such notice with the following form of notification to the Secretary. One of the ways to sat- the purchaser: isfy the notification requirement under these provisions is to make certain I do not intend to be present at the point that notice is given to the packer or of transfer of possession of livestock sold by live poultry dealer within the pre- me to (name of packer, market agency, or scribed time by letter, mailgram, or dealer) for the purpose of receiving a check in payment for such livestock. telegram stating: I hereby direct (name of packer, market (1) Notification to preserve trust ben- agency, or dealer) to make payment for live- efits: stock purchased from me, by mailing a (2) Identification of packer or live check for the full amount of the purchase poultry dealer; price before the close of the next business (3) Identification of seller or poultry day following the purchase of livestock and grower; transfer of possession thereof or, in the case (4) Date of the transaction; of a purchase on a ‘‘carcass’’ or ‘‘grade and yield’’ basis, not later than the close of the (5) Date of seller’s or poultry grow- first business day following determination of er’s receipt of notice that payment in- the purchase price. strument has been dishonored (if appli- This does not constitute an extension of cable); and credit to (name of packer, market agency or

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dealer). This is subject to cancellation by me Stockyard owners and market agencies at any time, and if not cancelled by (date), it will have substantial flexibility in set- shall terminate on that date. ting their own rates and charges. If the seller, for reasons other than not (c) Complaints filed about the rea- being present to receive payment, pre- sonableness of rates and charges will be fers to have the packer, market agen- investigated to determine the validity cy, or dealer make payment by mailing of such complaints and appropriate ac- a check within the time limit as pro- tion taken if warranted. vided in section 409(a), he may use the (d) Grain Inspection, Packers and above form but should not include the Stockyards Administration (Packers statement in the first sentence that he and Stockyards Programs) will con- does not intend to be present. tinue to insure that the schedules of (b) The Grain Inspection, Packers rates and charges filed with the De- and Stockyards Administration (Pack- partment are applied uniformly and in ers and Stockyards Programs) believes a nondiscriminatory manner. that such an agreement would not con- (Approved by the Office of Management and stitute an extension of credit within Budget under control number 0590–0001) the meaning of section 206 of the Act (7 U.S.C. 203, 204, 207, 217a, 222 and 228) because it would not give the purchaser [49 FR 33004, Aug. 20, 1984] any more time to issue a check than is provided in section 409(a). § 203.18 Statement with respect to packers engaging in the business of (Approved by the Office of Management and custom feeding livestock. Budget under control number 0590–0001) (a) In its administration of the Pack- (Sec. 401, 42 Stat. 168 (7 U.S.C 221); sec. 407, 42 Stat. 169 (7 U.S.C. 228); sec. 409, as added by ers and Stockyards Act, the Grain In- sec. 7, 90 Stat. 1250 (7 U.S.C. 228b); 7 CFR 2.17, spection, Packers and Stockyards Ad- 2.54; 42 FR 35625; Pub. L. 96–511, 94 Stat. 2812 ministration (Packers and Stockyards (44 U.S.C. 3501 et seq.); 7 U.S.C. 222 and 228 Programs) has sought to promote and and 15 U.S.C. 46) maintain open and fair competition in [42 FR 49929, Sept. 28, 1977, as amended at 49 the livestock and packing industries, FR 39516, Oct. 9, 1984] and to prevent unfair or anticompeti- tive practices when they are found to § 203.17 Statement of general policy exist. It is the opinion of the Adminis- with respect to rates and charges at tration that the ownership or oper- posted stockyards. ation of custom feedlots by packers (a) Requests have been received from presents problems which may, under stockyard operators, market agencies, some circumstances, result in viola- and livestock producers urging a reduc- tions of the Packers and Stockyards tion of rate regulation at posted stock- Act. yards. Their requests are based on the (b) Packers contemplating entering belief that competition among markets into such arrangements with custom will set a level of rates and charges fair feedlots are encouraged to consult with to both the market operator and to the the Administration prior to the com- livestock producer. Grain Inspection, mencement of such activities. Custom Packers and Stockyards Administra- feedlots are not only places of production (Packers and Stockyards Pro- tion, but are also important marketing grams) will accept for filing tariffs con- centers, and in connection with the op- taining any level of charges after 10 eration of a custom feedlot, it is cus- days’ notice to the public and to the tomary for the feedlot operator to as- Secretary as required by the Act. sume responsibility for marketing fed (b) Grain Inspection, Packers and livestock for the accounts of feedlot Stockyards Administration (Packers customers. When a custom feedlot is and Stockyards Programs) will not in- owned or operated by a packer, and vestigate the level of rates and charges when such packer purchases fed live- established by stockyard owners and stock from the feedlot, this method of market agencies for reasonableness ex- operation potentially gives rise to a cept upon receipt of a valid complaint conflict of interest. In such situations, or under compelling circumstances the packer’s interest in the fed live- warranting such an investigation. stock as a buyer is in conflict with its

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obligations to feedlot customers to some circumstances, may result in vio- market their livestock to the cus- lations of the Packers and Stockyards tomer’s best advantage. Under these Act. circumstances, the packer should take (b) Traditionally, livestock dealers appropriate measures to eliminate any and buying agencies purchase livestock conflict of interest. At a minimum, for resale or to fill orders for farmers, such measures should insure: ranchers, producers, other livestock (1) That feedlot customers are fully firms and packers. When a livestock advised of the common ties between dealer or buying agency is owned or op- the feedlot and the packer, and of their erated by a packer, and when such rights and options with respect to the packer is also buying livestock for its marketing of their livestock; own operational requirements, there is (2) That all feedlot customers are a potential conflict of interest. Fur- treated equally by the packer/custom thermore, the purchase and sale of live- feedlot in connection with the market- stock by meat packers may result in ing of fed livestock; and control of markets and prices which (3) That marketing decisions rest could adversely affect both livestock solely with the feedlot customer unless producers, competing packers, and con- otherwise expressly agreed. sumers. (c) Packer ownership or operation of (c) Arrangements between packers custom feedlots may also give rise to and dealers or buying agencies which competitive problems in some situa- do not normally create a conflict of in- tions. Packers contemplating or engag- terest or result in a restraint of coming in the business of operating a cus- petition include: tom feedlot should carefully review (1) Operations utilizing different spe- their operations to assure that no re- cies or classes of livestock; (2) oper- striction of competition exists or is ations where the business activities are likely to occur. widely separated geographically; and (d) The Grain Inspection, Packers (3) operations where tie-in purchases or and Stockyards Administration (Pack- sales are not involved. Packers con- ers and Stockyards Programs) does not templating engaging in the business of consider the existence of packer/cus- a livestock dealer or a buying agency tom feedlot relationships, by itself, to are encouraged to consult with the constitute a violation of the Act. In Grain Inspection, Packers and Stock- the event it appears that a packer/cus- yards Administration (Packers and tom feedlot arrangement gives rise to a Stockyards Programs) prior to the violation of the Act, an investigation commencement of such activities. will be made on a case-by-case basis, (d) In the event a packer/dealer or a and, where warranted, appropriate ac- packer/buying agency arrangement ap- tion will be taken. pears to give rise to a violation of the Act, an investigation will be made on a (Approved by the Office of Management and case-by-case basis and, where war- Budget under control number 0590–0001) ranted, appropriate action will be (7 U.S.C. 203, 204, 207, 217a, 222 and 228) taken. [49 FR 33004, Aug. 20, 1984] (Approved by the Office of Management and § 203.19 Statement with respect to Budget under control number 0590–0001) packers engaging in the business of (7 U.S.C. 228, 228b, 222, 15 U.S.C. 46) livestock dealers or buying agen- [49 FR 32845, Aug. 17, 1984; 54 FR 26349, June cies. 23, 1989] (a) In its administration of the Pack- ers and Stockyards Act, the Grain In- PART 204—ORGANIZATION AND spection, Packers and Stockyards Ad- FUNCTIONS ministration (Packers and Stockyards Programs) has sought to prevent con- PUBLIC INFORMATION flicts of interest and to maintain open Sec. and fair competition in the livestock 204.1 Introduction. and meat packing industries. The own- 204.2 Organization. ership or operation of livestock dealers 204.3 Delegation of authority. or buying agencies by packers, under 204.4 Public inspection and copying.

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204.5 Indexes. maintenance of relations and commu- 204.6 Requests for records. nications with producer and industry 204.7 Appeals. groups. AUTHORITY: 5 U.S.C. 552. (1) Administrator. The Secretary of SOURCE: 49 FR 46528, Nov. 27, 1984, unless Agriculture has delegated responsibil- otherwise noted. ity for administration of the Packers and Stockyards Act to the Adminis- PUBLIC INFORMATION trator who is responsible for the general direction and supervision of pro- § 204.1 Introduction. grams and activities assigned to the The Grain Inspection, Packers and Grain Inspection, Packers and Stock- Stockyards Administration (Packers yards Administration (Packers and and Stockyards Programs) hereby de- Stockyards Programs) except such ac- scribes its central and field organiza- tivities as are reserved to the Judicial tion; indicates the established places at Officer (32 FR 7468). The Administrator which, and methods whereby, the pub- reports to the Assistant Secretary for lic may secure information; directs at- Marketing and Inspection Services. tention to the general course and (2) Deputy Administrator. The Deputy method by which its functions are Administrator assists the Adminis- channeled; and sets forth the proce- trator in the overall responsibility for dures governing the availability of the general direction and supervision opinions, orders, and other records in of programs and activities assigned to the files of said Administration. the Grain Inspection, Packers and Stockyards Administration (Packers § 204.2 Organization. and Stockyards Programs). (a) The Grain Inspection, Packers (3) Assistant to the Administrator. The and Stockyards Administration (Pack- Assistant to the Administrator partici- ers and Stockyards Programs) consists pates with the Administrator and Dep- of a headquarters office located in the uty Administrator in the development South Building of the U.S. Department and analysis of policies and programs, of Agriculture in Washington, DC, and and directs the management support 12 regional offices. The Washington services and related activities of the headquarters office is organized to in- Grain Inspection, Packers and Stock- clude the Office of the Administrator yards Administration (Packers and and two Divisions, the Packer and Stockyards Programs). Poultry Division and the Livestock (4) Director, Industry Analysis Staff. Marketing Division. The Director of the Industry Analysis (b) Office of the Administrator. This of- Staff participates with the Adminis- fice has overall responsibility for ad- trator and Deputy Administrator in ministering the provisions of the Pack- the development and analysis of poli- ers and Stockyards Act, 1921, as cies and programs and directs eco- amended and supplemented (7 U.S.C. nomic studies of structure and per- 181 et seq.), for enforcement of the formance of the livestock, meat, and Truth-in-Lending Act (15 U.S.C. 1601– poultry marketing, processing, and 1665) with respect to any activities sub- wholesaling industries. The results of ject to the Packers and Stockyards Act these studies are used to provide eco- and for executing assigned civil defense nomic advice to the Administrator in and defense mobilization activities. developing overall policy on antitrust These responsibilities include formula- matters and effects of practices or im- tion of current and long-range pro- pediments in the marketing system. grams relating to assigned functions; The Director works closely with the execution of the policies and programs Directors of the Packer and Poultry administered by the Grain Inspection, and the Livestock Marketing Divisions Packers and Stockyards Administra- in connection with investigations to tion (Packers and Stockyards Pro- provide economic advice and expert grams); review and evaluation of pro- testimony in trials and administrative gram operations for uniform, effective, hearings. The Director also coordinates and efficient administration of the activities and works closely with the Packers and Stockyards Act; and Federal Trade Commission and Justice

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Department in studying the effects of the development and evaluation of mergers and antitrust matters in the policies and programs to fulfill the livestock, meat packing and poultry Agency’s responsibilities and func- industries. tions. The Director implements and di- (c) Packer and Poultry Division. This rects the policies and programs per- Division carries out the enforcement of taining to the Livestock Marketing Di- the provisions of the Packers and vision through the three branches. Stockyards Act relating to packers and (e) Field Services. (1) The field services live poultry dealers and handlers. The of the Grain Inspection, Packers and responsibilities and functions include: Stockyards Administration (Packers Determination of applicability of the and Stockyards Programs) is divided provisions of the Act to individual into 12 regional offices. These offices packer and poultry operations; surveil- are responsible for supervision of oper- lance of these operations; investigation ations of stockyard companies, market of complaints; initiation of formal pro- agencies, dealers, packers and live ceedings, when warranted, to correct poultry dealers and handlers to assure illegal practices; and maintenance of compliance with the Act. They formu- working relationships with the meat late recommendations relating to the packer and poultry industries. These enforcement of the Act; receive and in- responsibilities and functions are ac- vestigate complaints, including repara- complished with programs and activi- tion complaints; audit books, records, ties directed through the Livestock and reports of persons subject to the Procurement Branch, Meat Mer- chandising Branch, and Poultry Act; conduct investigations to deter- Branch. The Division Director partici- mine the existence of and develop evi- pates with the Administrator and Dep- dence of unfair, deceptive, and dis- uty Administrator in the development criminatory trade practices; prepare and evaluation of policies and pro- investigative reports and recommend grams to fulfill the Agency’s respon- corrective action; assist in the prosecu- sibilities and functions. The Director tion of cases; review applications for implements and directs the policies registration and rate changes for accu- and programs pertaining to the Packer racy and compliance; and maintain re- and Poultry Division through the three lationships with producers, the trade, branches. States and other groups interested in (d) Livestock Marketing Division. This the welfare of the livestock, meat Division enforces those provisions of packing, and poultry industries con- the Packers and Stockyards Act relat- cerning enforcement of the Act. ing to stockyard owners, market agen- (2) The addresses and the States cov- cies, and dealers. The responsibilities ered by these offices, which are under and functions include: determination of regional supervisors, are as follows: the applicability of the jurisdiction, Atlanta—Room 338, 1720 Peachtree Street, bonding, financial and trade practice NW., Atlanta, Georgia 30309 (Alabama, provisions of the Act to individual op- Florida, Georgia, South Carolina) erations; supervision of the installa- Bedford—Turnpike Road, Box 101E, Bedford, tion, maintenance, and testing of Virginia 25423 (District of Columbia, Dela- scales; surveillance and investigations ware, Maryland, North Carolina, Virginia, of stockyards, market agencies, and West Virginia) dealers; initiation of formal proceed- Denver—208 Livestock Exchange Building, ings, when warranted, to correct illegal Denver, Colorado 80216 (Colorado, Mon- practices; and maintenance of working tana, New Mexico, Utah, Wyoming) relationships with producer and indus- Fort Worth—Room 8A36, Federal Building, try groups. These responsibilities and 819 Taylor Street, Fort Worth, Texas 76102 functions are accomplished with pro- (Oklahoma, Texas) grams and activities directed through Indianapolis—Room 434 Federal Building and U.S. Courthouse, 46 E. Ohio Street, Indian- the Financial Protection Branch, Mar- apolis, Indiana 46204 (Illinois, Indiana, Ken- keting Practices Branch, and Scales tucky, Michigan, Ohio) and Weighing Branch. The Division Di- Kansas City—828 Livestock Exchange Build- rector participates with the Adminis- ing, Kansas City, Missouri 64102 (Kansas, trator and Deputy Administrator in Missouri)

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Lawndale—15000 Aviation Boulevard, Room Federal Trade Commission Act (15 2W6, P.O. Box 6102, Lawndale, California U.S.C. 46(b)), and, with respect thereto, 90261 (Arizona, California, Hawaii, Nevada) to issue notices of default provided for Memphis—Room 459, Federal Building, 167 in section 10 of the Federal Trade Com- Main Street, Memphis, Tennessee 38103 (Arkansas, Louisiana, Mississippi, Ten- mission Act (15 U.S.C. 50); to notify nessee) persons deemed to be subject to the North Brunswick—825 Georges Road, Room bonding requirements in 7 U.S.C. 204 of 303, North Brunswick, New Jersey 08902 their obligations to file bonds or trust (Connecticut, Maine, Massachusetts, New fund agreements in conformity with Hampshire, New Jersey, New York, Penn- regulations issued under this chapter sylvania, Rhode Island, Vermont) including authority to determine that Omaha—909 Livestock Exchange Building, Omaha, Nebraska 68107 (Iowa, Nebraska) a bond is inadequate under § 201.30(f) of Portland—9370 S.W. Greenburg Road, Suite this chapter and to give notice to the E, Portland, Oregon 97223 (Alaska, Idaho, person of the amount of bond required; Oregon, Washington) to notify persons deemed to be subject South St. Paul—208 Post Office Building, to the reporting requirements in Box 8, South St. Paul, Minnesota 55075 § 201.97 of this chapter of their obliga- (Minnesota, North Dakota, South Dakota, tions to file annual reports; and to Wisconsin) grant reasonable requests for exten- § 204.3 Delegation of authority. sions of 30 days or less for the filing of such annual reports. (a) Deputy Administrator. Under the (2) The Regional Supervisors are direction of the Administrator, the hereby individually delegated author- Deputy Administrator is hereby dele- ity, when there is reason to believe gated authority to perform all the du- that there is a question as to the true ties and exercise all the functions and ownership of livestock sold by any per- powers which are now or which may son, to disclose information relating to hereafter be, vested in the Adminis- trator (including the power of redelega- such questionable ownership to any in- tion). terested person. (b) Division Directors. The Directors of (d) Investigative employees. All em- the Industry Analysis Staff, the Live- ployees of the Grain Inspection, Pack- stock Marketing Division, and the ers and Stockyards Administration Packer and Poultry Division, under ad- (Packers and Stockyards Programs) as- ministrative and technical direction of signed to or responsible for investiga- the Administrator and the Deputy Ad- tions in the enforcement of the Pack- ministrator, are hereby individually ers and Stockyards Act, 1921, as delegated authority, in connection amended (7 U.S.C. 181 et seq.), or the en- with the respective functions assigned forcement of the Truth-in-Lending Act to each of said organizational units in (15 U.S.C. 1601–1665), with respect to § 204.2 to perform all the duties and to any activities subject to the Packers exercise all the functions and powers and Stockyards Act, are hereby indi- which are now, or which may hereafter vidually delegated authority under the be, vested in the Administrator (in- Act of January 31, 1925, 43 Stat. 803, 7 cluding the power of redelegation) ex- U.S.C. 2217, to administer to or take cept such authority as is reserved to from any person an oath, affirmation, the Administrator and Deputy Admin- or affidavit whenever such oath, affir- istrator under paragraph (g) of this sec- mation, or affidavit is for use in any tion. prosecution or proceeding under or in (c) Regional Supervisors. (1) The Re- the enforcement of the aforementioned gional Supervisors of the Grain Inspec- Acts. This authority may not be re- tion, Packers and Stockyards Adminis- delegated and will automatically ex- tration (Packers and Stockyards Pro- pire upon the termination of the em- grams) are hereby individually dele- ployment of such employees with the gated authority under the provisions of Grain Inspection, Packers and Stock- section 402 of the Packers and Stock- yards Administration (Packers and yards Act, 1921, as amended (7 U.S.C. Stockyards Programs). 222), to issue special orders pursuant to (e) Concurrent authority. No delega- the provisions of section 6(b) of the tion prescribed herein shall preclude

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the Administrator or Deputy Adminis- Grain Inspection, Packers and Stock- trator from exercising any of the pow- yards Administration (Packers and ers or functions or from performing Stockyards Programs, United States any of the duties conferred upon them, Department of Agriculture, Washing- and any such delegation is subject at ton, DC 20250. all times to withdrawal or amendment (b) Copies of such materials may be by the Administrator or Deputy Ad- obtained in person or by mail. Applica- ministrator or the Division Director ble fees for copies will be charged in ac- responsible for the function involved. cordance with the regulations pre- (f) Prior delegations. All prior delega- scribed by the Director of Information, tions and redelegations of authority re- Office of Governmental and Public Af- lating to any function or activity cov- fairs, USDA. ered by these delegations of authority shall remain in effect except as they § 204.5 Indexes. are inconsistent herewith or are here- Pursuant to the regulations in 7 CFR after amended or revoked. Nothing 1.4(b), the Grain Inspection, Packers herein shall affect the validity of any action heretofore taken under prior and Stockyards Administration (Pack- delegations or redelegations of author- ers and Stockyards Programs) will ity or assignment of functions. maintain and make available for public (g) Reservations of authority. It is inspection and copying current indexes hereby reserved to the Administrator of all material required to be made and Deputy Administrator authority available in 7 CFR 1.2(a). Notice is with respect to proposed rulemaking hereby given that publication of these and final action for the issuance of reg- indexes is unnecessary and impractical, ulations (§ 201.1 of this chapter et seq.), since the material is voluminous and rules of practice governing proceedings does not change often enough to justify (§ 202.1 of this chapter et seq.), and the expense of publication. statements of general policy (§ 203.1 of § 204.6 Requests for records. this chapter et seq.), and the issuance of moving papers as prescribed in the (a) Requests for records under 5 rules of practice governing formal ad- U.S.C. 552(a)(3) shall be made in accord- judicatory administrative proceedings ance with 7 CFR 1.3(a). Authority to instituted by the Secretary (7 CFR part make determinations regarding initial 1, subpart H, § 1.133); and the authority requests in accordance with 7 CFR to make final determinations in ac- 1.4(c) is delegated to the Freedom of In- cordance with the provisions of 7 CFR formation Act Officer of the Grain In- Part 1, Subpart A, as to the availabil- spection, Packers and Stockyards Ad- ity of official records and information ministration (Packers and Stockyards made or obtained in connection with Programs). Requests should be submit- the administration of the Packers and ted to the FOIA Officer at the follow- Stockyards Act which are considered ing address: Freedom of Information exempt from disclosure under § 204.7 of Act Officer (FOIA Request), Grain In- this part. Further, authority to issue spection, Packers and Stockyards Ad- subpenas (7 U.S.C. 222 and 15 U.S.C. 49) ministration (Packers and Stockyards is reserved to the Administrator and Programs), United States Department Deputy Administrator. of Agriculture, Washington, DC 20250. (b) The request shall identify each § 204.4 Public inspection and copying. record with reasonable specificity as (a) Facilities for public inspection prescribed in 7 CFR 1.3. and copying of the indexes and mate- (c) The FOIA Officer is authorized to rials required to be made available receive requests and to exercise the au- under 7 CFR 1.2(a) will be provided by thority to (1) make determination to the Grain Inspection, Packers and grant requests or deny initial requests; Stockyards Administration (Packers (2) extend the administrative deadline; and Stockyards Programs) during nor- (3) make discretionary release of ex- mal hours of operation. Requests for empt records; and (4) make determina- this information should be made to the tions regarding charges pursuant to Freedom of Information Act Officer, the fee schedule.

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§ 204.7 Appeals. 2.56(a)(3), as amended June 17, 1986, 51 FR 22795; Sections 662 and 663, Pub. L. 104–127. Any person whose request under § 204.6 of this part is denied shall have SOURCE: 51 FR 29451, Aug. 18, 1986, unless the right to appeal such denial in ac- otherwise noted. cordance with 7 CFR 1.3(e). Appeals DEFINITIONS shall be addressed to the Adminis- trator, Grain Inspection, Packers and § 205.1 Definitions. Stockyards Administration (Packers Terms defined in section 1324 of the and Stockyards Programs), U.S. De- Food Security Act of 1985, Pub. L. 99– partment of Agriculture, Washington, 198, 99 Stat. 1535, 7 U.S.C. 1631, shall DC 20250. mean the same in this part as therein. In addition, except as otherwise speci- PART 205—CLEAR TITLE—PROTEC- fied, as used in this part: TION FOR PURCHASERS OF FARM (a) The Secretary means the Secretary PRODUCTS of Agriculture of the United States; (b) The Section means section 1324 of DEFINITIONS the above-cited Act, and ‘‘subsection’’ means a subsection of that Section; Sec. (c) SYSTEM means central filing system 205.1 Definitions. as defined in subsection (c)(2); REGULATIONS (d) EFS means effective financing 205.101 Certification—request and process- statement as defined in subsection (c)(4); ing. (e) System operator means Secretary 205.102 Name of person subjecting a farm of State or other person designated by product to a security interest, on EFS a State to operate a system; and master list—format. (f) Registrant means any buyer of 205.103 EFS—minimum information. farm products, commission merchant, 205.104 Registration of buyer, commission or selling agent, as referred-to in the merchant, or selling agent—minimum in- Section, registered with a system formation. under subsection (c)(2)(D); 205.105 Master list and portion thereof distributed to registrants—format. (g) Master list means the accumula- 205.106 Farm products. tion of data in paper, electronic, or 205.107 Crop year. other form, described in subsection (c)(2)(C); INTERPRETIVE OPINIONS (h) Portion means portion of the mas- 205.201 System operator. ter list distributed to registrants under 205.202 ‘‘Effective financing statement’’ or subsection (c)(2)(E); EFS. (i) UCC or Uniform Commercial Code 205.203 Place of filing EFS. means the Uniform Commercial Code 205.204 Filing ‘‘notice’’ of EFS. prepared under the joint sponsorship of 205.205 Fees. 205.206 Farm products. the American Law Institute and the 205.207 ‘‘Amount’’ and ‘‘reasonable descrip- National Conference of Commissioners tion of the property.’’ on Uniform State Laws, and in effect in 205.208 Distribution of portions of master most States of the United States at the list—registration—information to non- time of enactment of Pub. L. 99–198. registrants on request. 205.209 Amendment or continuation of EFS. REGULATIONS 205.210 Effect of EFS outside State in which filed. § 205.101 Certification—request and 205.211 Applicability of court decisions processing. under the UCC. (a) To obtain certification of a sys- 205.212 ‘‘Buyer in ordinary course of business’’ and ‘‘security interest.’’ tem, a written request for certification 205.213 Obligations subject—‘‘person in- must be filed together with such docu- debted’’—‘‘debtor.’’ ments as show that the system com- 205.214 Litigation as to whether a system is plies with the Section. If such material operating in compliance with the Sec- is voluminous, a summary, table of tion. contents, and index must accompany it AUTHORITY: Section 1324(I), Pub. L. 99–198, as necessary to facilitate review. 99 Stat. 1535, 7 U.S.C. 1631; 7 CFR 2.17 (e)(3), (b) The request must:

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(1) Include an introductory expla- (i) All State legislation or other legal nation of how the system will operate; authority under which the system is (2) Identify the information which created and operated, and the system will be required to be supplied on an operator is designated; EFS; (ii) All regulations, rules and require- (3) Identify where an EFS, amendments issued under such legislation or ment thereto, or continuation thereof, other legal authority and governing op- will be filed and, if elsewhere than with eration of the system, designation of the system operator, explain how and the system operator, and use of the in what form the system operator will system by members of the public; and receive information needed to compile (iii) All printed and electronic forms and update the master list; required to be used in connection with (4) Explain the method for recording the system. the date and hour of filing of an EFS, (c) Any such request and attach- amendment thereto, or continuation ments must be filed in triplicate (one thereof; copy for public inspection, a second copy for use in GIPSA, and a third (5) Explain how the master list will copy for use in the Office of the Gen- be compiled, including the method and eral Counsel, USDA). All three copies form of storage and arrangement of in- must be received in the headquarters of formation, explain the method and the Grain Inspection, Packers and form of retrieval of information from Stockyards Administration Packers the master list, the method and form of and Stockyards Programs), USDA, distribution of portions of the master Washington, DC 20250. list to registrants as required by sub- (d) A refusal to certify such a system, section (c)(2)(E), and the method and if any, will be explained in writing. Re- form of furnishing of information oral- consideration of such a refusal must be ly with written confirmation as re- requested in writing with specification quired by subsection (c)(2)(F) (details of errors believed to have been made. of computer hardware and software (e) To make changes to an existing need not be furnished but the results it certified central filing system, includ- will produce must be explained); ing changes necessitated or made pos- (6) Explain how the list of registrants sible by amendments to the Act, a will be compiled, including identifica- written request to amend the existing tion of where and how they will reg- certified central filing system must be ister, what information they must sup- filed together with such documents as ply in connection with registration, are necessary to show that the system and the method and form of storage complies with the Act. The request and retrieval of such information (de- must contain relevant new information tails of computer hardware and soft- consistent with the requirements speci- ware need not be furnished but the re- fied elsewhere in this section. sults it will produce must be explained); [51 FR 29451, Aug. 18, 1986, as amended at 61 (7) Show how frequently portions of FR 54728, Oct. 22, 1996] the master list will be distributed regu- § 205.102 Name of person subjecting a larly to registrants; farm product to a security interest, (8) Show the farm products according on EFS and master list—format. to which the master list will be orga- On an EFS, and on a master list, the nized; name of the person subjecting a farm (9) Show how the system will inter- product to a security interest must ap- pret the term ‘‘crop year’’ and how it pear as follows: will classify as to crop year an EFS not (a) In the case of a natural person, showing crop year; the surname (last name or family (10) Show what fee will be charged name) must appear first; and explain how the costs of the sys- (b) In the case of a corporation or tem will be covered if not by such fee other entity not a natural person, the and the general revenue of the State; name must appear beginning with the and first word or character not an article (11) Include copies of: or punctuation mark.

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§ 205.103 EFS—minimum information. (c) A requirement of additional infor- (a) The minimum information nec- mation on a registration form is discre- essary on an EFS is as follows: tionary with the State. (1) Crop year unless every crop of the farm product in question, for the dura- § 205.105 Master list and portion thereof distributed to registrants—for- tion of the EFS, is to be subject to the mat. particular security interest; (2) Farm product name (see §§ 205.106, (a) The master list must contain all 205.206); the information on all the EFS’s filed (3) Each county or parish in the same in the system, so arranged that it is State where the farm product is pro- possible to deliver to any registrant all duced or to be produced; such information relating to any prod- (4) Name and address of each person uct, produced in any county or parish subjecting the farm product to the se- (or all counties or parishes), for any curity interest, whether or not a debt- crop year, covered by the system. The or (see § 205.102); system must be able to deliver all such (5) Social security number or, if information to any registrant, either other than a natural person, IRS tax- in alphabetical order by the word ap- payer identification number, of each pearing first in the name of each per- such person; son subjecting a product to a security (6) Further details of the farm prod- interest (see § 205.102), in numerical uct subject to the security interest if needed to distinguish it from other order by social security number (or, if such product owned by the same person other than a natural person, IRS tax- or persons but not subject to the par- payer identification number) of each ticular security interest (see § 205.207); such person, or in both alphabetical and and numerical orders, as requested by (7) Secured party name and address. the registrant. (b) A requirement of additional infor- (b) Section (c)(2)(E) requires the por- mation on an EFS is discretionary tion to be distributed in ‘‘written or with the State. printed form.’’ This means recording (c) Whether to permit one EFS to re- on paper by any technology in a form flect multiple products, or products in that can be read by humans without multiple counties, is discretionary special equipment. The system may, with the State. however, honor requests from registrants to substitute recordings on § 205.104 Registration of buyer, commission merchant, or selling any medium by any technology includ- agent—minimum information. ing, but not limited to, electronic re- (a) The minimum information nec- cording on tapes or discs in machine- essary on a registration of a buyer, readable form, and on photographic re- commission merchant, or selling agent cording on microfiche. It also includes, is as follows: if requested by registrants, electronic (1) Buyer, commission merchant, or transmissions whereby registrants can selling agent name and address; print their own paper copies. (2) Farm product or products (see (c) After distribution of a portion of §§ 205.106, 205.206) in which registrant is a master list, there can be supple- interested; and mentary distribution of a portion (3) If registrant is interested only in showing only changes from the pre- such product or products produced in a vious one. However, if this is done, cu- certain county or parish, or certain mulative supplements must be distrib- counties or parishes, in the same State, uted often enough that readers can find the name of each such county or par- all the information given to them for ish. any one crop year in no more than (b) A registrant, if not registered for three distributions. any specified county or parish, or counties or parishes, must be deemed to [51 FR 29451, Aug. 18, 1986, as amended at 61 have registered for all counties and FR 54728, Oct. 22, 1996] parishes shown on the master list.

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§ 205.106 Farm products. ment by which a security interest is The farm products, according to created or perfected. Note also the which the master list must be orga- House Committee Report on Pub. L. 99– nized as required by subsection (c)(2), 198, No. 99–271, Part 1, September 13, and which must be identified on an 1985, at page 110: ‘‘[T]he bill would not EFS as required by subsection preempt basic state-law rules on the (c)(4)(D)(iv), must be specific commod- creation, perfection, or priority of se- ities, species of livestock, and specific curity interests.’’ products of crops or livestock. The Sec- (b) An EFS may be filed electroni- tion does not permit miscellaneous cally provided a State allows elec- categories. tronic filing of financing statements without the signature of the debtor § 205.107 Crop year. under applicable State law under provi- (a) The crop year, according to which sions of the Uniform Commercial Code subsection (c)(2)(C)(ii)(IV) requires the or may be a paper document. An elec- master list to be arranged ‘‘within each tronically filed EFS need not be a such product,’’ must be: paper document and need not be (1) For a crop grown in soil, the cal- signed. If an original or reproduced endar year in which it is harvested or paper document of an EFS is filed with to be harvested; (2) For animals, the calendar year in the State, it must be signed by both which they are born or acquired; the secured party and the debtor, and (3) For poultry or eggs, the calendar be filed by the secured party. year in which they are sold or to be (c) Countermeasures against mis- sold. handling after filing, such as a require- (b) An EFS or notice thereof which ment that a copy be date stamped and does not show crop year (the Section returned to the secured party, are dis- does not require it to do so) must be re- cretionary with the State. If a State garded as applicable to the crop or chooses to adopt such counter- product in question for every year for measures, it is responsible for estab- which subsection (c)(4)(F) makes the lishing procedures for recording the EFS effective. date and time when an EFS is received, and for meeting all legal requirements INTERPRETIVE OPINIONS associated with filing and distributing § 205.201 System operator. information about security interests as The system operator can be the Sec- required by § 205.101. retary of State of a State, or any des- [51 FR 29451, Aug. 18, 1986, as amended at 61 ignee of the State pursuant to its laws. FR 54728, Oct. 22, 1996] Note that the provision in subsection (c)(2) for a system refers to operation § 205.203 Place of filing EFS. by the Secretary of State of a State, The place of filing an EFS is wher- but the definition in (c)(11) of ‘‘Sec- ever State law requires, which need not retary of State’’ includes ‘‘designee of be with the system operator so long as the State.’’ the system operator receives the infor- § 205.202 ‘‘Effective financing state- mation needed for the master list, in- ment’’ or EFS. cluding the information required in (a) An EFS under subsection (c)(4) subsection (c)(4)(D). Note that the re- need not be the same as a financing quirements in subsection (c)(4) for an statement or security agreement under EFS include the requirement that it be the Uniform Commercial Code (or ‘‘filed with the Secretary of State,’’ equivalent document under future suc- but the definition in (c)(11) of ‘‘Sec- cessor State law), but can be an en- retary of State’’ includes ’’designee of tirely separate document meeting the the State,’’ and the requirements in definition in (c)(4). Note that (c)(4) con- (c)(2) for a system refer in (A) to filing tains a comprehensive definition of the with the system operator of ‘‘effective term which does not include any re- financing statements or notice of such quirement that the EFS be the instru- financing statements.’’ (emphasis added)

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§ 205.204 Filing ‘‘notice’’ of EFS. Artichokes, asparagus, beans lima, beans snap, beets, Brussels sprouts, broccoli, cab- (a) If an EFS is filed somewhere bage, carrots, cauliflower, celery, corn sweet, other than with the system operator, cucumbers, eggplant, escarole, garlic, let- and if notice of it is filed with the sys- tuce, onions, peas green, peppers, spinach, tem operator, such notice could be tomatoes, other truck crops (system must electronic filing, telephoned informa- specify by name) tion, or any other form of notice which Melons (system must specify by name) gives the system operator the informa- Grapefruit, lemons, limes, oranges, tan- gelos, tangerines, other citrus fruits (system tion needed for the master list. Such must specify by name) notice need not be signed. Note that Apples, apricots, avocados, bananas, cher- the Section does not contain any re- ries, coffee, dates, figs, grapes (& raisins), quirement for such notice except the nectarines, olives, papayas, peaches, pears, one in subsection (c)(4)(B) that an EFS persimmons, pineapples, plums (& prunes), must be filed somewhere pursuant to pomegranates, other noncitrus fruits (sys- State law as discussed above. tem must specify by name) Berries (system must specify by name) (b) Countermeasures against fal- Tree nuts (system must specify by name) sifications, errors or omissions in such Bees wax, honey, maple syrup, sugar beets, notices or in the handling of them by sugar cane, other sugar crops (system must the system operator, such as require- specify by name) ments that the notices be on paper and Grass seeds, legume seeds, other seed crops signed, with copies date-stamped and (system must specify by name) returned to the persons filing them, Hops, mint, popcorn, other miscellaneous crops (system must specify by name) however advisable they might be from Greenhouse & nursery products produced other standpoints, are discretionary on farms (system must specify by name) with the State and not required by the Mushrooms, trees, other forest products Section. (system must specify by name) Chickens, ducks, eggs, geese, turkeys, § 205.205 Fees. other poultry or poultry products (system The Section provides at subsection must specify by name) Cattle & calves, goats, horses, hogs, mules, (c)(4)(H) for a fee for filing an EFS. The sheep & lambs, other livestock (system must fee can be set in any manner provided specify by name) by the law of the State in which such Milk, other dairy products produced on EFS is filed. The basis for this is that farms (system must specify by name) (c)(4)(H) provides for the fee to be set Wool, mohair, other miscellaneous live- by the ‘‘Secretary of State’’ but (c)(11) stock products produced on farms (system defines the latter term to include ‘‘des- must specify by name) Fish, shellfish ignee of the State.’’ The fee structure Other farm products (system must specify is discretionary with the State. by name). § 205.206 Farm products. (b) Note the definition of the term (a) The master list must be organized ‘‘farm product’’ at subsection (c)(5), by farm product as required by sub- and the Conference Report on Pub. L. section (c)(2), and the farm product 99–198, No. 99–447, December 17, 1985, at must be identified on an EFS as re- page 486. quired by subsection (c)(4)(D)(iv). The (c) A State may establish a system following is a list of such farm prod- for specified products and not for all. A ucts. State establishing a system for speci- Rice, rye, wheat, other food grains (system fied products and not for all will be must specify by name) deemed to be ‘‘a State that has estab- Barley, corn, hay, oats, sorghum grain, lished a central filing system’’ as to other feed crops (system must specify by the specified products, and will be name) deemed not to be such a State as to Cotton other products. Tobacco Flaxseed, peanuts, soybeans, sunflower § 205.207 ‘‘Amount’’ and ‘‘reasonable seeds, other oil crops (system must specify description of the property.’’ by name) Dry beans, dry peas, potatoes, sweet pota- (a) The ‘‘amount’’ of farm products toes, taro, other vegetables (system must and ‘‘reasonable description of the specify by name) property including county or parish,’’

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on an EFS and on the master list under the effect, under subsections (e)(2) and subsections (c)(4)(D)(iv) and (2)(C)(iii), (g)(2)(C), of making such persons, need not be shown on every EFS and whether they are inside or outside the master list entry. State covered by that system, subject (b) Any EFS and master list entry to security interests shown on that will identify a product. If they do not system’s master list whether or not show an amount, this constitutes a rep- such persons know about them, so that resentation that all of such product such persons for their own protection owned by the person in question is sub- will need to query the system operator ject to the security interest in ques- about any seller ‘‘engaged in farming tion. operations,’’ of a farm product pro- (c) Any EFS and master list entry duced in the State covered by that sys- will identify each county or parish in tem, with whom they deal. the same State where the product is or (c) The effect of registration by such is to be produced. If they do not show persons with a particular system is to any further identification of the loca- get them on the list for regular dis- tion of the product, this constitutes a tribution of portions of that system’s representation that all such product master list, the portions to be deter- produced in each such county or par- mined by the registration. They are ish, owned by such person, is subject to subject only to security interests the security interest. shown on the portions which they re- (d) The need to supply additional in- ceive, and are not subject to such information arises only where some of terests as are shown on the master list that product owned by that person is but not shown on portions which they subject to the security interest and receive. Also, if a particular security some is not. interest is shown on the master list, (e) The additional information about but has been placed on it since the last amount and property must be suffi- regular distribution of portions of that cient to enable a reader of the informa- list to registrants, registrants would tion to identify what product owned by not be subject to that security inter- that person is subject, as distinguished est. These conclusions are based on the from what of the same product owned provisions in subsections (e)(3)(A) and by the same person is not subject. The (g)(2)(D)(i) that such persons are sub- precision needed, in the description of ject to a security interest only if they the amount and location, would vary receive ‘‘written notice * * * that from case to case. specifies both the seller and the farm (f) The basis for this is the purpose of product.’’ the entire exercise, to make informa- (d) A question arises as to the length tion available as necessary to enable of time for which a registration is ef- an identification of what product is fective, and whether a registrant, wish- subject to a security interest as distin- ing to change registration as to county guished from what is not. or product, can amend an existing registration or must file a new one. This is § 205.208 Distribution of portions of discretionary with the State since the master list—registration—informa- Section is silent about it. tion to non-registrants on request. (e) A question arises whether persons (a) The provisions in the Section re- can register to receive only portions of garding registration of ‘‘buyers of farm the list for products in which they do products, commission merchants, and not deal, and thus not be subject to se- selling agents,’’ ‘‘regular’’ distribution curity interests in products in which of ‘‘portions’’ of the master list, fur- they deal because they are registrants nishing of ‘‘oral confirmation * * * on but do not receive written notice of request,’’ and the effect of all this, that them. For example, can cattle dealers is, subsections (c)(2) (D), (E) and (F), (e) register to receive portions of the mas- (2) and (3), and (g)(2) (C) and (D), must ter list only for oranges, and thus take be read together. cattle free and clear of security inter- (b) The Section does not require such ests shown on the master list, but as to persons to register. Not registering which they do not receive written no- with a particular system operator has tice because they have not registered

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to receive the portion for cattle? Reg- (j) In the matter of receiving queries istrants will be deemed to be registered and giving oral replies to them, sub- only as to those portions of the master section (c)(2)(F) will be complied with list for which they register, and will be if a system operator maintains an of- deemed to have failed to register as to fice and staff where a query can be re- those portions for which they do not ceived on business days and during register. business hours such as are regular in (f) The Section requires ‘‘regular’’ the State, and where an oral reply will distribution, to registrants, of portions be available on the regular business of the master list as amended from day following the day on which the time to time by the filing of EFS’s and query is received, at or before the time amendments to EFS’s. The require- of day when it was received. ment that the distribution be ‘‘regu- (k) Written confirmation is required, lar’’ necessarily refers to an interval by subsection (c)(2)(F), to be given to specified in advance. The interval may any non-registered buyer, commission vary according to product and region. merchant, or selling agent. The frequency of such distribution (l) Such a written confirmation pur- must be a consideration in review for suant to subsection (c)(2)(F) does not certification since distribution must be alter the liability of the non-registrant timely to serve its purpose. While subsection (c)(2)(E) (providing that dis- querying the system and receiving in- tribution be made ‘‘regularly as pre- formation about a security interest re- scribed by the State’’) gives each State corded in it. The basis of this, as above, discretion to choose the interval be- is that non-registrants are subject to tween distributions, whatever interval security interests recorded in a system a State chooses will inevitably make whether or not they know about them, possible some transactions in which se- and must query the system for their curity interests are filed in the system own protection. but registrants are not subject to (m) The Section does not specify them. when or how the written confirmation (g) Legislative history of the Section must be furnished, but provides only shows that buyers, commission mer- that it must follow the oral informa- chants, and selling agents are not in- tion. Thus the time and method of fur- tended to be liable for errors or other nishing written confirmation is discre- inaccuracies generated by the system. tionary with the State. See Nov. 22, 1985 Cong. Rec., Senate, pg. S16300, and Dec. 18, 1985 Cong. Rec., § 205.209 Amendment or continuation House, pg. H12523. of EFS. (h) In furnishing to non-registrants (a) The ‘‘material change,’’ required ‘‘oral confirmation within 24 hours of by subsection (c)(4)(E) to be reflected any [EFS] on request followed by writ- in an amendment to an EFS and mas- ten confirmation,’’ by a system opera- ter list entry, is whatever change tor pursuant to subsection (c)(2)(F), would render the master list entry no any failure in use of a telephone caused longer informative as to what is sub- by a ‘‘busy signal’’ could not be the ject to the security interest in ques- basis of liability of the system operation. That will vary from case to case. tor. The basis for this is that sub- The basis for this is the purpose for section (c)(2)(F) does not mention tele- which the information is supplied, that phones. Also, while it mentions furnish- is, to make information available, to a ing information orally, it does not con- buyer, commission merchant, or selling tain any provision as to how queries agent who proposes to enter into a are to be received, that is, orally, in transaction in a product, whether it is writing, or otherwise. subject to a security interest. The re- (i) Of course it is to be expected that quirement to amend arises when the telephones would be used in most cases, but use of them is not required information already made available no by the legislation and is discretionary longer serves the purpose and other in- with the State. formation is needed in order to do so.

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(b) Where an owner of a product written notice of it even if they are out- makes a change, such as planting a dif- side that State. All of these provisions ferent crop or purchasing different ani- apply only where an EFS is filed in the mals from what was represented, with- system for the State in which the prod- out informing the secured party, so uct is produced. They do not apply to a that the master list entry is rendered filing in another system. not informative, but the EFS and mas- (c) What constitutes ‘‘receipt’’ of no- ter list are not amended through no tice is determined by the law of the fault of the secured party, the Section State in which the intended recipient is silent as to the consequences. How- of notice resides. This is based on sub- ever, see the legislative history cited section (f) which follows provisions for in § 205.208(f). notice to buyers, and (g)(3) which fol- (c) The amendment must be filed in lows provisions for notice to commis- the same manner as the original filing. sion merchants and selling agents. Note the requirement of section Each of those provisions uses the word (c)(4)(E). The amendment may be filed ‘‘buyer’’ but it means ‘‘intended recipi- electronically provided a State allows ent of notice.’’ electronic filing of financing statements without the signature of the § 205.211 Applicability of court deci- debtor under applicable State law sions under the UCC. under provisions of the Uniform Com- (a) Court decisions under the Uni- mercial Code. An electronically filed form Commercial Code (UCC), about amendment need not be signed. How- the scope of the ‘‘farm products’’ ex- ever, if an original or reproduced paper ception in Section 9–307(1) thereof, and document is filed, the amendment interpreting the terms therein, par- must be signed by the secured party ticularly ‘‘person engaged in farming and the debtor, and be filed by the se- operations’’ which is not defined in the cured party. Section, are applicable to an extent in (d) A continuation of an EFS is sub- interpreting the Section. The basis of ject to the same requirement as an this is the legislative intent of the Sec- amendment. The EFS as first filed ex- tion to pre-empt State laws reflecting pires in a given time. A continuation that ‘‘farm products’’ exception, as modifies it as to its expiration date and shown in the House Committee Report thus is an amendment. on Pub. L. 99–198, No. 99–271, Part 1, September 13, 1985, at pages 108 et seq. [51 FR 29451, Aug. 18, 1986, as amended at 61 (b) That UCC Section 9–307(1) reads as FR 54728, Oct. 22, 1996] follows: § 205.210 Effect of EFS outside State in (1) A buyer in ordinary course of business which filed. (subsection (9) of Section 1–201) other than a (a) A question arises whether, if an person buying farm products from a person en- EFS is filed in one State, a notice of it gaged in farming operations takes free of a security interest created by his seller even can be filed in another State and shown though the security interest is perfected and on the master list for the second State. even though the buyer knows of its exist- There is nothing in the Section to pre- ence. (emphasis added) vent this, but it would serve no purpose. § 205.212 ‘‘Buyer in ordinary course of (b) The Section provides only for fil- business’’ and ‘‘security interest.’’ ing an EFS, covering a given product, The terms ‘‘buyer in ordinary course in the system for the State in which it of business’’ and ‘‘security interest’’ is produced. Upon such filing in such are defined in subsections (c) (1) and system, subsections (e)(2) and (g)(2)(C) (7). There are differences between those make buyers, commission merchants definitions and the UCC definitions of and selling agents not registered with the same terms. In interpreting those that system subject to the security in- differences, the following would be per- terest in that product whether or not tinent: they know about it, even if they are out- (a) The legislative intent discussed side that State. Subsections (e)(3) and above in § 205.211, to pre-empt State (g)(2)(D) make persons registered with laws reflecting the ‘‘farm products’’ ex- that system subject if they receive ception; and

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(b) The legislative intent shown in wherever State law requires, and if the subsections (a) and (b) that certain per- system operator receives the informa- sons take free and clear of certain in- tion about them needed for the master terests of a ‘‘secured lender’’ ‘‘when the list. seller fails to repay the lender,’’ unless (d) A system can be in compliance such persons have information about with the Section, although it reflects such interests made available to them security interests not supported by as provided in the Section. EFS’s as defined in the legislation, and although it reflects security interests § 205.213 Obligations subject—‘‘person on items other than farm products. indebted’’—‘‘debtor.’’ However, subsections (e) (2) and (3), and (a) A debt need not exist at the time (g)(2) (C) and (D), will apply only as to of filing of an EFS. The basis for this is entries reflecting farm products and that subsection (c)(4) does not require supported by EFS’s as defined in the the EFS, and subsection (c)(2)(C) does Section, and it must be possible to dis- not require the master list, to show tinguish the entries to which these pro- any amount of debt. visions apply from the other entries. (b) The Section does not provide for the transaction in which one person § 205.214 Litigation as to whether a subjects a product to a security inter- system is operating in compliance est for another’s debt. However the with the Section. terms ‘‘person indebted’’ and ‘‘debtor’’ (a) The requirements for a system in in the Section refer to the person who subsection (c) are written as the defini- owns a product and subjects it to a se- tion of the term ‘‘central filing sys- curity interest, whether or not that tem,’’ so that failure of a system to person owes a debt to the secured meet any such requirement, either at party. The basis for this is the purpose the time of its establishment or later, for which the information is supplied. will mean that it is not a ‘‘central fil- Any buyer of a farm product, commis- ing system’’ as defined. sion merchant, or selling agent (b) The issue whether a system, after querying a master list or system opera- certification, is operating in compli- tor about a prospective seller of a farm ance, thus whether it is a ‘‘central fil- product is interested in whether that ing system’’ as defined, could be liti- seller has subjected that product to a gated and ruled on in a case involving security interest, not in whether the only private parties, such as a lender debt is owed by that seller or by an- and a buyer of a farm product. The other. only immediate effect of a finding in (c) Security interests existing prior such a case, that a system is not a to establishment of a system can be ‘‘central filing system’’ as defined, filed in such a system and reflected in would be that the rights of the secured the master list if documents are in ex- party in the case would be as if the istence or are created which meet the State had no system. However, others requirements of subsection (c)(4) be- would be in doubt as to whether they sides filing, if such documents are filed could safely rely on the same system.

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SUBCHAPTER A—MANDATORY MEAT INSPECTION

Part Page 301 Definitions ...... 75 302 Application of inspection and other requirements .. 81 303 Exemptions ...... 82 304 Application for inspection; grant or refusal of inspection ...... 90 305 Official numbers; inauguration of inspection; withdrawal of inspection; reports of violation ...... 92 306 Assignment and authorities of program employees 93 307 Facilities for inspection ...... 94 308 Sanitation ...... 99 309 Ante-mortem inspection ...... 105 310 Post-mortem inspection ...... 113 311 Disposal of diseased or otherwise adulterated carcasses and parts ...... 129 312 Official marks, devices and certificates ...... 138 313 Humane slaughter of livestock ...... 143 314 Handling and disposal of condemned or other inedible products at official establishments ...... 149 315 Rendering or other disposal of carcasses and parts passed for cooking ...... 152 316 Marking products and their containers ...... 152 317 Labeling, marking devices, and containers ...... 158 318 Entry into official establishments; reinspection and preparation of products ...... 233 319 Definitions and standards of identity or composition ...... 317 320 Records, registration, and reports ...... 336 321 Cooperation with States and territories ...... 339

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Part Page 322 Exports ...... 339 325 Transportation ...... 341 327 Imported products ...... 352 329 Detention; seizure and condemnation; criminal offenses ...... 370 331 Special provisions for designated States and Terri- tories; and for designation of establishments which endanger public health and for such designated establishments ...... 372 335 Rules of practice governing proceedings under the Federal Meat Inspection Act ...... 378

SUBCHAPTER B—VOLUNTARY INSPECTION AND CERTIFICATION SERVICE

350 Special services relating to meat and other products ...... 383 351 Certification of technical animal fats for export .... 385 352 Exotic animals; voluntary inspection ...... 392 354 Voluntary inspection of rabbits and edible products thereof ...... 399 355 Certified products for dogs, cats, and other carnivora; inspection, certification, and identification as to class, quality, quantity, and condition ...... 424 362 Voluntary poultry inspection regulations ...... 436

SUBCHAPTER C—MANDATORY POULTRY PRODUCTS INSPECTION

381 Poultry products inspection regulations ...... 441

SUBCHAPTER D—FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS

390 Freedom of information ...... 670 391 Fees and charges for inspection services and laboratory accreditation ...... 672

SUBCHAPTER E—REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT

416 Sanitation ...... 673 417 Hazard Analysis and Critical Control Point (HACCP) Systems ...... 674

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PART 301—DEFINITIONS make such article unfit for human food; Sec. (ii) If it is, in whole or in part, a raw 301.1 Meaning of terms. agricultural commodity and such com- 301.2 Definitions. modity bears or contains a pesticide AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. chemical which is unsafe within the 601–695; 7 CFR 2.17, 2.55. meaning of section 408 of the Federal Food, Drug, and Cosmetic Act; § 301.1 Meaning of terms. (iii) If it bears or contains any food As used in this subchapter, unless additive which is unsafe within the otherwise required by the context, the meaning of section 409 of the Federal singular form shall also import the plu- Food, Drug, and Cosmetic Act; ral and the masculine form shall also (iv) If it bears or contains any color import the feminine, and vice versa. additive which is unsafe within the meaning of section 706 of the Federal [35 FR 15554, Oct. 3, 1970] Food, Drug, and Cosmetic Act: Pro- vided, That an article which is not § 301.2 Definitions. deemed adulterated under paragraphs As used in this subchapter, unless (aa)(2) (ii), (iii), or (iv) of this section otherwise required by the context, the shall nevertheless be deemed adulter- following terms shall be construed, re- ated if use of the pesticide chemical spectively, to mean: food additive, or color additive in or on (a) The Act. The Federal Meat Inspec- such article is prohibited by the regu- tion Act, as amended, (34 Stat. 1260, as lations in this subchapter in official es- amended, 81 Stat. 584, 84 Stat. 438, 92 tablishments; Stat. 1069, 21 U.S.C., sec. 601 et seq.). (3) If it consists in whole or in part of (b) Administrator. The Administrator any filthy, putrid, or decomposed sub- of the Food Safety and Inspection stance or is for any other reason un- Service or any officer or employee of sound, unhealthful, unwholesome, or the Department to whom authority has otherwise unfit for human food; heretofore been delegated or may here- (4) If it has been prepared, packed, or after be delegated to act in his/her held under unsanitary conditions stead. whereby it may have become contami- (c) Adulterated. This term applies to nated with filth, or whereby it may any carcass, part thereof, meat or meat have been rendered injurious to health; food product under one or more of the (5) If it is, in whole or in part, the following circumstances: product of an animal which has died (1) If it bears or contains any such otherwise than by slaughter; poisonous or deleterious substance (6) If its container is composed, in which may render it injurious to whole or in part, of any poisonous or health; but in case the substance is not deleterious substance which may an added substance, such article shall render the contents injurious to not be considered adulterated under health; this clause if the quantity of such sub- (7) If it has been intentionally substance in or on such article does not jected to radiation, unless the use of ordinarily render it injurious to health; the radiation was in conformity with a (2)(i) If it bears or contains (by rea- regulation or exemption in effect pur- son of administration of any substance suant to section 409 of the Federal to the live animal or otherwise) any Food, Drug, and Cosmetic Act; added poisonous or added deleterious (8) If any valuable constituent has substance (other than one which is: been in whole or in part omitted or ab- (A) A pesticide chemical in or on a stracted therefrom; or if any substance raw agricultural commodity; has been substituted, wholly or in part (B) A food additive; or therefor; or if damage or inferiority (C) A color additive) which may, in has been concealed in any manner; or if the judgment of the Administrator, any substance has been added thereto

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or mixed or packed therewith so as to (l) Capable of use as human food. This increase its bulk or weight, or reduce term applies to any carcass, or part or its quality or strength, or make it ap- product of a carcass, of any livestock, pear better or of greater value than it unless it is denatured or otherwise is; or, identified as required by the applicable (9) If it is margarine containing ani- provisions of §§ 314.3, 314.10, 325.11, and mal fat and any of the raw material 325.13 of this subchapter to deter its use used therein consisted in whole or in as a human food, or it is naturally in- part of any filthy, putrid, or decom- edible by humans; e.g., hoofs or horns posed substance, or is otherwise adul- in their natural state. terated. (m) Captive bolt. A stunning instru- (d) Anesthesia. Loss of sensation or ment which when activated drives a feeling. bolt out of a barrel for a limited dis- (e) Animal food. Any article intended tance. for use as food for dogs, cats, or other (n) Carbon dioxide. A gaseous form of animals derived wholly, or in part, the chemical formula CO2. from the carcass or parts or products of (o) Carbon dioxide concentration. Ratio the carcass of any livestock, except of carbon dioxide gas and atmospheric that the term animal food as used here- air. in does not include: (p) Carcass. All parts, including (1) Processed dry animal food or viscera, of any slaughtered livestock. (2) Livestock or poultry feeds manu- (q) Chemical preservative. Any chemi- factured from processed livestock by- cal that, when added to a meat or meat products (such as meatmeal tankage, food product, tends to prevent or re- meat and bonemeal, bloodmeal, and tard deterioration thereof, but does not feed grade animal fat). include common salt, sugars, vinegars, (f) Animal food manufacturer. Any per- spices, or oils extracted from spices or son engaged in the business of manu- substances added to meat and meat facturing or processing animal food. food products by exposure to wood (g) Area. One or more circuits under smoke. the supervision of an area supervisor. Other definitions, if any, that are ap- (h) Area Supervisor. The official in plicable only for purposes of a specific charge of an area. part of the regulations in this sub- (i) Artificial coloring. A coloring con- chapter, are set forth in such part. taining any dye or pigment, which dye (r) Circuit. One or more official estab- or pigment was manufactured by a lishments included under the super- process of synthesis or other similar vision of a circuit supervisor. artifice, or a coloring which was manu- (s) Circuit supervisor. The supervisor factured by extracting a natural dye or of a circuit. natural pigment from a plant or other (t) Commerce. Commerce between any material in which such dye or pigment State, any Territory, or the District of was naturally produced. Columbia, and any place outside there- (j) Artificial flavoring. A flavoring of; or within any Territory not orga- containing any sapid or aromatic con- nized with a legislative body, or the stituent, which constituent was manu- District of Columbia. factured by a process of synthesis or (u) Consciousness. Responsiveness of other similar artifice. the brain to the impressions made by (k) Biological residue. Any substance, the senses. including metabolites, remaining in (v) Cutting up. Any division of any livestock at time of slaughter or in any carcass or part thereof, except that the of its tissues after slaughter as the re- trimming of carcasses or parts thereof sult of treatment or exposure of the to remove surface contaminants is not livestock to a pesticide, organic or in- considered as cutting up. organic compound, hormone, hormone- (w) Dead livestock. The body (cadaver) like substance, growth promoter, anti- of livestock which has died otherwise biotic, anthelmintic, tranquilizer, or than by slaughter. other therapeutic or prophylactic (x) The Department. The United agent. States Department of Agriculture.

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(y) Dying, diseased, or disabled live- York City), Connecticut, Rhode Island, Ver- stock. Livestock which has or displays mont, New Hampshire and Maine. symptoms of having any of the follow- IFO #2. New York, NY—Covering the areas of New York City and northern New Jersey. ing: IFO #3. Philadelphia, PA—Covering the (1) Central nervous system disorder; State of Pennsylvania and the area of south- (2) Abnormal temperature (high or ern New Jersey. low); IFO #4. Baltimore, MD—Covering the (3) Difficult breathing; States of Maryland, Delaware, West Vir- (4) Abnormal swellings; ginia, Virginia and Kentucky. IFO #5. Charleston, SC—Covering the (5) Lack of muscular coordination; States of Tennessee, North Carolina, South (6) Inability to walk normally or Carolina, Georgia and Florida (excluding stand; south Florida). (7) Any of the conditions for which 1IFO #6. Miami, FL—Covering the areas of livestock is required to be condemned southern Florida, Puerto Rico and the Virgin on ante-mortem inspection in accord- Islands. 1IFO #7. New Orleans, LA—Covering the ance with the regulations in Part 309 of States of Louisiana, Mississippi, Alabama, this subchapter. Arkansas, Texas, Oklahoma, Kansas, New (z) Edible. Intended for use as human Mexico and Colorado. food. 1IFO #8. San Pedro, CA—Covering the (aa) Experimental animal. Any animal States of Hawaii, Arizona, Utah, Nevada, the used in any research investigation in- area of southern California, American Samoa, Guam, and the Northern Marianas. volving the feeding or other adminis- 1IFO #9. Tacoma, WA—Covering the States tration of, or subjection to, an experi- of Washington, Oregon, Idaho, Montana, Wy- mental biological product, drug, or oming, North Dakota, South Dakota, Alas- chemical or any nonexperimental bio- ka, and Nebraska, and the area of northern logical product, drug, or chemical used California. in a manner for which it was not in- 1IFO #10. Detroit, MI—Covering the States tended. of Michigan, Wisconsin, Minnesota, Iowa, Missouri, Illinois, Indiana and Ohio. (bb) Exposure time. The period of time an animal is exposed to an anesthesia- (ii) Import Supervisor. The official in producing carbon dioxide concentra- charge of import inspection activities tion. within each of the import field offices. (cc) Federal Food, Drug, and Cosmetic (jj) Inedible. Adulterated, Act. The Act so entitled, approved June uninspected, or not intended for use as 25, 1938 (52 Stat. 1040), and Acts amend- human food. atory thereof or supplementary there- (kk) Inhumane slaughter or handling to. in connection with slaughter. Slaughter (dd) Firm. Any partnership, associa- or handling in connection with slaugh- tion, or other unincorporated business ter not in accordance with the Act of organization. August 27, 1958 (72 Stat. 862; 7 U.S.C. (ee) Food Safety and Inspection Service. 1901 through 1906, as amended by the The Food Safety and Inspection Serv- Humane Methods of Slaughter Act of ice of the Department. 1978, 92 Stat. 1069) and Part 313 of this subchapter. (ff) Further processing. Smoking, (ll) ‘‘Inspected and passed’’ or ‘‘U.S. cooking, canning, curing, refining, or Inspected and Passed’’ or ‘‘U.S. Inspected rendering in an official establishment and Passed by Department of Agri- of product previously prepared in offi- culture’’ (or any authorized abbreviation cial establishments. thereof). This term means that the (gg) Immediate container. The recep- product so identified has been in- tacle or other covering in which any spected and passed under the regula- product is directly contained or wholly tions in this subchapter, and at the or partially enclosed. time it was inspected, passed, and iden- (hh) Import Field Office (IFO). The of- tified, it was found to be not adulter- fice of the supervisor of import inspec- ated. tion activities for a particular import- (mm) Inspector. An inspector of the ing field area. The areas are as follows: Program. IFO #1. Boston, MA—Covering the States (nn) Inspector in charge. A designated of Massachusetts, New York (excluding New program employee who is in charge of

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one or more official establishments (tt) Meat byproduct. Any part capable within a circuit and is responsible to of use as human food, other than meat, the circuit supervisor or his/her des- which has been derived from one or ignee. more cattle, sheep, swine, or goats. (oo) Label. A display of written, This term, as applied to products of printed, or graphic matter upon the equines, shall have a meaning com- immediate container (not including parable to that provided in this para- package liners) of any article. graph with respect to cattle, sheep, (pp) Labeling. All labels and other swine, and goats. written, printed, or graphic matter: (uu) Meat food product. Any article (1) Upon any article or any of its con- capable of use as human food which is tainers or wrappers, or made wholly or in part from any meat (2) Accompanying such article. or other portion of the carcass of any (qq) Livestock. Cattle, sheep, swine, cattle, sheep, swine, or goats, except goat, horse, mule, or other equine. those exempted from definition as a (rr) Meat. (1) The part of the muscle meat food product by the Adminis- of any cattle, sheep, swine, or goats, trator in specific cases or by the regu- which is skeletal or which is found in lations in part 317 of this subchapter, the tongue, in the diaphragm, in the upon a determination that they con- heart, or in the esophagus, with or tain meat or other portions of such without the accompanying and over- carcasses only in a relatively small lying fat, and the portions of bone, proportion or historically have not skin, sinew, nerve, and blood vessels been considered by consumers as prod- which normally accompany the muscle ucts of the meat food industry, and tissue and which are not separated provided that they comply with any re- from it in the process of dressing. It quirements that are imposed in such does not include the muscle found in cases or regulations as conditions of the lips, snout, or ears. This term, as such exemptions to assure that the applied to products of equines, shall meat or other portions of such car- have a meaning comparable to that casses contained in such articles are provided in this paragraph with respect not adulterated and that such articles to cattle, sheep, swine, and goats. are not represented as meat food prod- (2) The product derived from the me- ucts. This term, as applied to food chanical separation of the skeletal products of equines, shall have a mean- muscle tissue from the bones of live- ing comparable to that provided in this stock using the advances in mechanical paragraph with respect to cattle, meat/bone separation machinery and sheep, swine, and goats. meat recovery systems that do not (vv) Misbranded. This term applies to crush, grind, or pulverize bones, and any carcass, part thereof, meat or meat from which the bones emerge com- food product under one or more of the parable to those resulting from hand- following circumstances: deboning (i.e., essentially intact and in (1) If its labeling is false or mislead- natural physical conformation such ing in any particular; that they are recognizable, such as loin (2) If it is offered for sale under the bones and rib bones, when they emerge name of another food; from the machinery) which meets the (3) If it is an imitation of another criteria of no more than 0.15 percent or food, unless its label bears, in type of 150 mg/100 gm of product for calcium uniform size and prominence, the word (as a measure of bone solids content) ‘‘imitation’’ and immediately there- within a tolerance of 0.03 percent or 30 after, the name of the food imitated; mg. (4) If its container is so made, (ss) Meat broker. Any person engaged formed, or filled as to be misleading; in the business of buying or selling car- (5) If in a package or other container casses, parts of carcasses, meat or unless it bears a label showing: meat food products of livestock on (i) The name and place of business of commission, or otherwise negotiating the manufacturer, packer, or distribu- purchases or sales of such articles tor; and other than for his/her own account or (ii) An accurate statement of the as an employee of another person. quantity of the contents in terms of

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weight, measure, or numerical count; (11) If it bears or contains any artifi- except as otherwise provided in part 317 cial flavoring, artificial coloring, or of this subchapter with respect to the chemical preservative, unless it bears a quantity of contents; label stating that fact; except as other- (6) If any word, statement, or other wise provided by the regulations in information required by or under au- part 317 of this subchapter; or thority of the Act to appear on the (12) If it fails to bear, directly there- label or other labeling is not promi- on or on its containers, when required nently placed thereon with such con- by the regulations in part 316 or 317 of spicuousness (as compared with other this subchapter, the inspection legend words, statements, designs, or devices, and, unrestricted by any of the fore- in the labeling) and in such terms as to going, such other information as the render it likely to be read and under- Administrator may require in such reg- stood by the ordinary individual under ulations to assure that it will not have customary conditions of purchase and false or misleading labeling and that use; the public will be informed of the man- (7) If it purports to be or is rep- ner of handling required to maintain resented as a food for which a defini- the article in a wholesome condition. tion and standard of identity or com- (ww) Nonfood compound. Any sub- position has been prescribed by the reg- stance proposed for use in official es- ulations in part 319 of this subchapter tablishments, the intended use of unless: which will not result, directly or indi- (i) It conforms to such definition and rectly, in the substance becoming a standard, and component or otherwise affecting the (ii) Its label bears the name of the characteristics of meat food and meat food specified in the definition and products, excluding labeling and pack- standard and, insofar as may be re- aging materials as covered in part 317 quired by such regulations, the com- of the subchapter. mon names of optional ingredients (xx) Official certificate. Any certifi- (other than spices, flavoring, and color- cate prescribed by the regulations in ing) present in such food; this subchapter for issuance by an in- (8) If it purports to be or is rep- spector or other person performing offi- resented as a food for which a standard cial functions under the Act. or standards of fill of container have (yy) Official device. Any device pre- been prescribed by the regulations in scribed by the regulations in part 312 of part 319 of this subchapter, and it falls this subchapter for use in applying any below the standard of fill of container official mark. applicable thereto, unless its label (zz) Official establishment. Any slaugh- bears, in such manner and form as such tering, cutting, boning, meat canning, regulations specify, a statement that it curing, smoking, salting, packing, ren- falls below such standard; dering, or similar establishment at (9) If it is not subject to the provi- which inspection is maintained under sions of paragraph (vv)(7)(ii) of this the regulations in this subchapter. section unless its label bears: (aaa) Official import inspection estab- (i) The common or usual name of the lishment. This term means any estab- food, if any there be, and lishment, other than an official estab- (ii) In case it is fabricated from two lishment as defined in paragraph (zz) of or more ingredients, the common or this section, where inspections are au- usual name of each such ingredient, ex- thorized to be conducted as prescribed cept as otherwise provided in Part 317 in § 327.6 of this subchapter. of this subchapter; (bbb) Official inspection legend. Any (10) If it purports to be or is rep- symbol prescribed by the regulations in resented for special dietary uses, unless this subchapter showing that an article its label bears such information con- was inspected and passed in accordance cerning its vitamin, mineral, and other with the Act. dietary properties as is required by the (ccc) Official mark. The official in- regulations in part 317 of this sub- spection legend or any other symbol chapter. prescribed by the regulations in this

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subchapter to identify the status of Southwestern Region—Arkansas, Kansas, any article or animal under the Act. Louisiana, Missouri, Nebraska, New Mexico, (ddd) Packaging material. Any cloth, Oklahoma, and Texas. paper, plastic, metal, or other material Western Region—Alaska, Arizona, Califor- used to form a container, wrapper, nia, Colorado, Hawaii, Idaho, Montana, Ne- label, or cover for meat products. vada, North Dakota, Oregon, South Dakota, (eee) Person. Any individual, firm, or Utah, Washington, and Wyoming, American corporation. Samoa, Guam, and the Northern Mariana Is- (fff) Pesticide chemical, food additive, lands. color additive, raw agricultural commod- (lll) Renderer. Any person engaged in ity. These terms shall have the same the business of rendering carcasses or meanings for purposes of the Act and parts or products of the carcasses of the regulations in this subchapter as any livestock except rendering con- under the Federal Food, Drug, and Cos- ducted under inspection or exemption metic Act. under Title I of the Act. (ggg) Prepared. Slaughtered, canned, (mmm) Secretary. The Secretary of salted, rendered, boned, cut up, or oth- Agriculture of the United States or his/ erwise manufactured or processed. (hhh) Product. Any carcass, meat, her delegate. meat byproduct, or meat food product, (nnn) Shipping container. The outside capable of use as human food. container (box, bag, barrel, crate, or (iii) Program. The organizational unit other receptacle or covering) contain- within the Department having the re- ing or wholly or partly enclosing any sponsibility for carrying out the provi- product packed in one or more imme- sions of the Act. diate containers. (jjj) Program employee. Any inspector (ooo) State. Any State of the United or other individual employed by the States or the Commonwealth of Puerto Department or any cooperating agency Rico. who is authorized by the Secretary to (ppp) Supervision. The controls, as do any work or perform any duty in prescribed in instructions to Program connection with the Program. employees, to be exercised by them 1 (kkk) Regional Director. The official over particular operations to insure in charge of the program within each of that such operations are conducted in the following regions: compliance with the Act and the regu- Northeastern Region—Connecticut, Dela- lations in this subchapter. ware, District of Columbia, Maine, Mary- (qqq) Surgical anesthesia. A state of land, Massachusetts, New Hampshire, New unconsciousness measured in conform- Jersey, New York, Pennsylvania, Rhode Is- land, Vermont, and Virginia (except for ity with accepted surgical practices. Northwestern part). (rrr) Territory. Guam, the Virgin Is- Southeastern Region—Alabama, Florida, lands of the United States, American Georgia, Kentucky, Mississippi, North Caro- Samoa, and any other territory or pos- lina, South Carolina, Tennessee, Virginia session of the United States, excluding (Northwestern), West Virginia, Puerto Rico, and the Virgin Islands. the Canal Zone. North Central Region—Illinois, Indiana, (sss) U.S. Condemned. This term Iowa, Michigan, Minnesota, Ohio, and Wis- means that the livestock so identified consin. has been inspected and found to be in a dying condition, or to be affected with 1 The addresses of the Regional Directors any other condition or disease that are as follows: would require condemnation of its car- Northeastern Region—Seventh Floor, 1421 cass. Cherry Street, Philadelphia, PA 19102. Southeastern Region—Room 299 South, (ttt) U.S. Inspected and Condemned (or 1718 Peachtree Street, NW., Atlanta, GA any authorized abbreviation thereof). 30309. This term means that the carcass, North Central Region—607 East Second viscera, other part of carcass, or other Street, Des Moines, IA 50309. product so identified has been in- Southwestern Region—Room 5–F41, 1100 Commerce Street, Dallas, TX 75201. spected, found to be adulterated, and Western Region—Room 620 Central Ave- condemned under the regulations in nue, Building 2C, Alameda, CA 94501. this subchapter.

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(uuu) U.S. Passed for Cooking. This are slaughtered for transportation or term means that the meat or meat by- sale as articles of commerce, or in product so identified has been in- which any products of, or derived from, spected and passed on condition that it carcasses of livestock are, wholly or in be cooked or rendered as prescribed by part, prepared for transportation or the regulations in part 315 of this chap- sale as articles of commerce, which are ter. intended for use as human food; (vvv) U.S. Passed for Refrigeration. (2) Every establishment, except as This term means that the meat or provided in § 303.1 (a) and (b), or (d) of meat byproduct so identified has been this subchapter, within any State or inspected and passed on condition that organized Territory which is des- it be refrigerated or otherwise handled ignated pursuant to paragraph 301(c) of as prescribed by the regulations in the Act, at which any livestock are Part 311 of this subchapter. slaughtered or any products of any (www) U.S. Retained. This term livestock are prepared, for use as means that the carcass, viscera, other human food solely for distribution part of carcass, or other product, or ar- within such jurisdiction; and ticle so identified is held for further ex- (3) Every establishment, except as amination by an inspector to deter- provided in § 303.1(a) and (b) of this sub- mine its disposal. (xxx) U.S. Suspect. This term means chapter, that is designated by the Ad- that the livestock so identified is sus- ministrator pursuant to paragraph pected of being affected with a disease 301(c) of the Act as one producing adul- or condition which may require its con- terated products which would clearly demnation, in whole or in part, when endanger the public health. slaughtered, and is subject to further [35 FR 15556, Oct. 3, 1970, as amended at 36 FR examination by an inspector to deter- 12002, June 24, 1971] mine its disposal. (yyy) United States. The States, the § 302.2 Application of requirements in District of Columbia, and the Terri- designated States or Territories; tories of the United States. and to designated plants endangering public health. [35 FR 15554, Oct. 3, 1970] Special provisions with respect to es- EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 301.2, see the List of CFR tablishments and their operations and Sections Affected in the Finding Aids sec- transactions by any persons in des- tion of this volume. ignated States and Territories and with respect to establishments des- PART 302—APPLICATION OF IN- ignated as producing adulterated prod- SPECTION AND OTHER REQUIRE- ucts which clearly endanger public MENTS health, and the operators thereof, in any State or Territory appear in part Sec. 331 of this subchapter, and apply to 302.1 Establishments requiring inspection. such establishments, operations and 302.2 Application of requirements in des- transactions in lieu of the regulations ignated States or Territories; and to des- elsewhere in this subchapter except in- ignated plants endangering public sofar as such regulations are made ap- health. plicable by the provisions in part 331 of 302.3 Livestock and products entering offi- this subchapter. cial establishments.

AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, [35 FR 15556, Oct. 3, 1970, as amended at 51 FR 2.55. 29909, Aug. 21, 1986]

§ 302.1 Establishments requiring in- § 302.3 Livestock and products enter- spection. ing official establishments. (a) Inspection under the regulations All livestock and all products enter- in this subchapter is required at: ing any official establishment and all (1) Every establishment, except as products prepared, in whole or in part, provided in § 303.1(a) and (b), or (c) of therein, shall be inspected, handled, this subchapter, in which any livestock stored, prepared, packaged, marked,

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and labeled as required by the regula- Provided, That the provisions of said tions in this subchapter. sections relating to inspection or supervision of specified activities or [35 FR 15556, Oct. 3, 1970] other action by a Program employee shall not apply to the preparation and PART 303—EXEMPTIONS handling of such exempted products: Provided, further, That the requirement Sec. of § 308.4 for separate facilities for men 303.1 Exemptions. 303.2 Experimentation: Intensity of inspec- and women workers shall not apply to tion coverage. such establishments when the majority of the workers in the establishment are AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. related by blood or marriage and this arrangement will not conflict with mu- § 303.1 Exemptions. nicipal or State requirements, and the requirement of § 308.4 for separation of (a) The requirements of the Act and toilet soil lines from house drainage the regulations in this subchapter for inspection of the preparation of prod- lines to a point outside the buildings ucts do not apply to: will not apply to such establishments (1) The slaughtering by any individ- when positive acting backflow devices ual of livestock of his own raising, and are installed: And provided, further, the preparation by him and transpor- That the requirements of § 308.13 for tation in commerce of the carcasses, paved driveways, approaches, yards, parts thereof, meat and meat food pens, and alleys shall not apply to such products of such livestock exclusively establishments. However, if custom op- for use by him and members of his erations are conducted in an official es- household and his nonpaying guests tablishment, all of the provisions of and employees; part 308 shall apply to such establish- (2) The custom slaughter by any per- ment. son of cattle, sheep, swine, or goats de- (ii) If the custom operator prepares livered by the owner thereof for such or handles any products for sale, they slaughter, and the preparation by such are kept separate and apart from the slaughterer and transportation in com- custom prepared products at all times merce of the carcasses, parts thereof, while the latter are in his custody; meat and meat food products of such (iii) The custom prepared products livestock, exclusively for use, in the are plainly marked ‘‘Not for Sale’’ as household of such owner, by him and provided in § 316.16 of this subchapter, members of his household and his non- immediately after being prepared and paying guests and employees; nor to are kept so identified until delivered to the custom preparation by any person the owner; and of carcasses, parts thereof, meat or (iv) If exempted custom slaughtering meat food products derived from the or other preparation of products is con- slaughter by any individual of cattle, ducted in an official establishment, all sheep, swine, or goats of his own rais- facilities and equipment in the official ing or from game animals, delivered by establishment used for such custom op- the owner thereof for such custom erations shall be thoroughly cleaned preparation, and transportation in and sanitized before they are used for commerce of such custom prepared ar- preparing any products for sale. ticles, exclusively for use in the house- (b)(1) The exempted custom prepared hold of such owner, by him and mem- products shall be prepared and handled bers of his household and his nonpay- in accordance with the provisions of ing guests and employees: Provided, §§ 318.5, 318.6, 318.7, 318.10, and 318.300 That the following requirements are through 318.311 of this subchapter and met by such custom operator; shall not be adulterated as defined in (i) The establishment in which the paragraph 1(m) of the Act: Provided, custom operations are conducted is That the provisions of §§ 318.5, 318.6, maintained and operated in accordance 318.10, and 318.300 through 318.311 relat- with the provisions of §§ 308.4 through ing to inspection or supervision of 308.11, 308.13, 308.14, and 308.3 (except specified activities or other action by a § 308.3(d) (2) and (3), of this subchapter: Program inspector, and the provisions

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of § 318.6(b)(9) and (10), shall not apply products do not apply to operations of to the preparation and handling of such types traditionally and usually con- exempted products. ducted at retail stores and restaurants, (2) The exempted custom prepared when conducted at any retail store or products shall comply with the require- restaurant or similar retail-type estab- ments of §§ 316.16 and 317.16 of this sub- lishment for sale in normal retail chapter. quantities or service of such articles to (3) The custom operators claiming consumers at such establishments. exemption under paragraph (a)(2) of (2) For purposes of paragraph (d)(1) of this section shall keep records, in addi- this section: tion to records otherwise required by (i) Operations of types traditionally part 320 of this subchapter, showing the and usually conducted at retail stores numbers and kinds of livestock slaugh- and restaurants are the following: tered on a custom basis, the quantities (a) Cutting up, slicing, and trimming and types of products prepared on a carcasses, halves, quarters, or whole- custom basis, and the names and ad- sale cuts into retail cuts such as dresses of the owners of the livestock steaks, chops, and roasts, and freezing and products. such cuts; (4) Articles capable of use as human (b) Grinding and freezing products food, resulting from the exempted cus- made from meat; tom slaughter or other preparation of (c) CuRing, cooking, smoking, ren- products shall be promptly denatured dering or refining of livestock fat, or or otherwise identified in accordance other preparation of products, except with § 325.13 of this subchapter and not slaughtering or the retort processing of removed from the establishment where canned products; the custom operations are conducted (d) Breaking bulk shipments of prod- until so identified, unless they are de- ucts; livered to the owner of the articles for (e) Wrapping or rewrapping products. use in accordance with paragraph (a)(2) (ii) Any quantity or product pur- of this section. chased by a consumer from a particular (c) It has been determined that it is retail supplier shall be deemed to be a impracticable to provide inspection of normal retail quantity if the quantity the preparation of products at estab- so purchased does not in the aggregate lishments in any unorganized Territory exceed one-half carcass. The following at which livestock are slaughtered or amounts of product will be accepted as their products are prepared for dis- representing one-half carcass of the tribution solely within such jurisdic- species identified: tion and that exempting such estab- One-half lishments from requirements of the carcass Act for such inspections under the con- pounds ditions stated in this section will oth- Cattle ...... 300 erwise facilitate enforcement of the Calves ...... 37.5 Act. Therefore, such inspection re- Sheep ...... 27.5 Swine ...... 100 quirements of the Act and of the regu- Goats ...... 25 lations in this subchapter shall not apply at such establishments if they (iii) A retail store is any place of are operated in accordance with the business where: regulations in part 308 of this sub- (a) The sales of product are made to chapter, except §§ 308.1, 308.2, and 308.15. consumers only; However, the Administrator may (b) At least 75 percent, in terms of refuse, withdraw, or modify any exemp- dollar value, of total sales of product tion under this paragraph when he de- represents sales to household consum- termines in any specific case in accord- ers and the total dollar value of sales ance with the applicable rules of prac- of product to consumers other than tice that such action is necessary to ef- household consumers does not exceed fectuate the purposes of this Act. the dollar limitation per calendar year (d)(1) The requirements of the Act set by the Administrator. This dollar and the regulations in this subchapter limitation is a figure which will auto- for inspection of the preparation of matically be adjusted during the first

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quarter of each calendar year, upward (4) The preparation of product is lim- or downward, whenever the Consumer ited to traditional and usual operations Price Index, published by the Bureau of as defined in paragraph (d)(2)(i) of this Labor Statistics, Department of Labor, section. indicates a change in the price of this (b) The definition of a restaurant in- same volume of product which exceeds cludes a caterer which delivers or $500. Notice of the adjusted dollar limi- serves product in meals, or as entrees, tation will be published in the FEDERAL only to individual consumers and oth- 1 REGISTER. erwise meets the requirements of this (c) Only federally or State inspected paragraph. and passed product is handled or used (c) For purposes of this paragraph, in the preparation of any product, ex- operations conducted at a restaurant cept that product resulting from the custom slaughter or custom prepara- central kitchen facility shall be consid- tion of product may be handled or used ered as being conducted at a restaurant in accordance with paragraph (a)(2) and if the restaurant central kitchen pre- (b) of this section but not for sale; pares meat or meat food products that (d) No sale of product is made in ex- are ready to eat when they leave such cess of a normal retail quantity as de- facility (i.e., no further cooking or fined in paragraph (d)(2)(ii) of this sec- other preparation is needed, except tion; that they may be reheated prior to (e) The preparation of products for serving if chilled during transpor- sale to household consumers is limited tation), transported directly to a re- to traditional and usual operations as ceiving restaurant by its own employ- defined in paragraph (d)(2)(i) of this ees, without intervening transfer or section; and storage, maintained in a safe, unadul- (f) The preparation of products for terated condition during transpor- sale to other than household consum- tation, and served in meals or as ers is limited to traditional and usual entrees only to customers at res- operations as defined in paragraph taurants, or through vending ma- (d)(2)(i) (a), (b), (d), and (e) of this sec- chines, owned or operated by the same tion. (A retail store at which custom person that owns or operates such fa- slaughtering or preparation of products cility, and which otherwise meets the is conducted is not thereby disqualified requirements of this paragraph: Pro- from exemption as a retail store under vided, That the requirements of §§ 320.1 this paragraph (d).) through 320.4 of this subchapter apply (iv) Restaurants. (a) A restaurant is to such facility. Provided further, That any establishment where: the exempted facility may be subject (1) Product is prepared only for sale to inspection requirements under the or service in meals or as entrees di- Act for as long as the Administrator rectly to individual consumers at such deems necessary, if the Administrator establishments; determines that the sanitary condi- (2) Only federally or State inspected tions or practices of the facility or the and passed product or such product processing procedures or methods at prepared at a retail store exempted the facility are such that any of its under paragraph (d)(2)(iii) of this sec- meat or meat food products are ren- tion is handled or used in the prepara- dered adulterated. When the Adminis- tion of any product; trator has made such determination (3) No sale of product is made in ex- and subjected a restaurant central cess of a normal retail quantity as de- kitchen facility to such inspection refined in paragraph (d)(2)(ii) of this sec- quirements, the operator of such facil- tion; and ity shall be afforded an opportunity to dispute the Administrator’s determina- 1 The dollar limitation currently in effect tion in a hearing pursuant to rules of may be obtained by contacting Director, practice which will be adopted for this Slaughter Inspection Standards and Proce- proceeding. dures Division, Technical Services, Food and Safety Inspection Service, U.S. Department (v) Similar retail-type establishment: of Agriculture, Washington, DC 20250 (202) Any establishment which is a combina- 447–3219. tion retail store and restaurant; any

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delicatessen which meets the require- and passed in a cured or cooked form as ments for a retail store or restaurant ready-to-eat (i.e., no further cooking or as prescribed in paragraphs (d)(2) (iii) other preparation is needed) in compli- or (iv) of this section; or other estab- ance with the requirements of the Act lishment as determined by the Admin- and these regulations; and the meat istrator in specific cases. pizzas are to be served in public or pri- (vi) Consumer: Any household vate nonprofit institutions, provided consumer, hotel, restaurant, or similar that the meat pizzas are ready-to-eat institution as determined by the Ad- (i.e., no further cooking or other prepa- ministrator in specific cases. ration is needed, except that they may (3) Whenever any complaint is re- be reheated prior to serving if chilled ceived by the Administrator from any during transportation), transported di- person alleging that any retail store rectly to the receiving institution by claiming exemption under this para- employees of the preparing firm, re- graph (d), in any designated State or ceiving institution, or a food service organized Territory that is identified management company contracted to under section 205 of the Act (as one conduct food service at the public or that does not have or is not exercising private nonprofit institution, without adequate authority with respect to rec- intervening transfer or storage. ordkeeping requirements) has been op- (2) The definitions at Chapter 1, 1–102, erated in violation of the conditions except 1–102(z) and the provisions of prescribed in this section for exemp- Chapters 2 through 8, except sections 2– tion, and the Administrator, upon in- 102(a) and (b), 2–302(d), 2–403(a), 2–403(c), vestigation of the complaint, has rea- 2–404, 2–405, 2–407, 2–502 through 2–506, son to believe that any such violation 2–508, 2–509, 4–105, 4–201(c), 4–208, 5– has occurred, he shall so notify the op- 101(a), 5–103, 5–104, 5–202(c), 5–203, and 6– erator of the retail store and afford 105, part IV, of the Food and Drug Ad- him reasonable opportunity to present ministration’s Food Service Sanitation his views informally with respect to Manual (1976 Recommendations), the matter. Thereafter, if the Adminis- DHEW Publication No. (FDA) 78–2081, trator still has reason to believe that which is incorporated by reference, such a violation has occurred, and that shall apply to the facilities and oper- a requirement that the operator keep ations of businesses claiming this ex- records concerning the operations of emption. (These materials are incor- the retail store would effectuate the porated as they exist on the date of ap- purposes of the Act, the Administrator proval. This incorporation by reference shall order the operator to maintain was approved by the Director of the complete, accurate, and legible records Federal Register in accordance with 5 of total monthly purchases and of total U.S.C. 552(a) and 1 CFR part 51. Copies monthly sales of meat, meat byprod- may be purchased from the Super- ucts, and meat food products, in terms intendent of Documents, U.S. Govern- of dollar values of the products in- ment Printing Office, Washington, DC volved. Such records shall separately 20402. It is also available for inspection show total sales to household consum- at the Office of the Federal Register In- ers and total sales to other consumers formation Center, suite 700, 800 North and shall be maintained for the period Capitol Street, NW., Washington, DC, prescribed in § 320.3 of this subchapter. or the FSIS Hearing Clerk, room 3171, If the operator maintains copies of South Building, Food Safety and In- bills of lading, receiving and shipping spection Service, U.S. Department of invoices, warehouse receipts, or similar Agriculture, Washington, DC 20250.) documents which give the information (3) Facilities and operations of busi- required herein, additional records are nesses claiming this exemption shall not required by this subparagraph. also conform to the following require- (e) (1) The requirements of the Act ments: and the regulations in this subchapter (i) Manual cleaning and sanitizing. (A) for inspection of the preparation of For manual washing, rinsing and sani- products do not apply to meat pizzas tizing of utensils and equipment, a sink containing meat food product ingredi- with not fewer than three compart- ents which were prepared, inspected, ments shall be provided and used. Sink

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compartments shall be large enough to (4) Immersion in a clean solution permit the accommodation of the containing any other chemical sanitiz- equipment and utensils, and each coming agent allowed under 21 CFR 178.1010 partment of the sink shall be supplied that will provide the equivalent bac- with hot and cold potable running tericidal effect of a solution containing water. Fixed equipment and utensils at least 50 parts per million of avail- and equipment too large to be cleaned able chlorine as a hypochlorite at a in sink compartments shall be washed temperature of at least 75 °F for 1 manually or cleaned through pressure minute; or spray methods. (5) Treatment with steam free from (B) Drain boards or easily movable materials or additives other than those dish tables of adequate size shall be specified in 21 CFR 173.310 in the case provided for proper handling of soiled of equipment too large to sanitize by utensils prior to washing and for immersion, but in which steam can be cleaned utensils following sanitizing confined; or and shall be located so as not to inter- (6) Rinsing, spraying, or swabbing fere with the proper use of the dish- with a chemical sanitizing solution of washing facilities. at least twice the strength required for (C) Equipment and utensils shall be that particular sanitizing solution preflushed or prescraped and, when under paragraph (e)(3)(i)(E)(4) of this necessary, presoaked to remove gross section in the case of equipment too food particles and soil. large to sanitize by immersion. (D) Except for fixed equipment and (F) When hot water is used for sani- utensils too large to be cleaned in sink tizing, the following facilities shall be compartments, manual washing, rins- provided and used: ing and sanitizing shall be conducted in (1) An integral heating device or fix- the following sequence: ture installed in, on, or under the sani- (1) Sinks shall be cleaned prior to tizing compartment of the sink capable use. of maintaining the water at a tempera- (2) Equipment and utensils shall be ture of at least 170 °F; and thoroughly washed in the first com- (2) A numerically scaled indicating partment with a hot detergent solution thermometer, accurate to ±3 °F, con- that is kept clean. venient to the sink for frequent checks (3) Equipment and utensils shall be of water temperature; and rinsed free of detergent and abrasives (3) Dish baskets of such size and de- with clean water in the second com- sign to permit complete immersion of partment. the tableware, kitchenware, and equip- (4) Equipment and utensils shall be ment in the hot water. sanitized in the third compartment ac- (G) When chemicals are used for sani- cording to one of the methods pre- tization, they shall not have con- scribed in paragraph (e)(3)(i)(E) (1) centrations higher than the maximum through (4) of this section. permitted under 21 CFR 178.1010 and a (E) The food-contact surfaces of all test kit or other device that accurately equipment and utensils shall be sani- measures the parts per million con- tized by: centration of the solution shall be pro- (1) Immersion for at least 1⁄2 minute vided and used. in clean, hot water at a temperature of (ii) Mechanical cleaning and sanitizing. at least 170 °F; or (A) Cleaning and sanitizing may be (2) Immersion for at least 1 minute in done by spray-type or immersion dish- a clean solution containing at least 50 washing machines or by any other type parts per million of available chlorine of machine or device if it is dem- as a hypochlorite and at a temperature onstrated that it thoroughly cleans of at least 75 °F; or and sanitizes equipment and utensils. (3) Immersion for at least 1 minute in These machines and devices shall be a clean solution containing at least 12.5 properly installed and maintained in parts per million of available iodine good repair. and having a pH not higher than 5.0 Machines and devices shall be oper- and at a temperature of at least 75 °F; ated in accordance with manufactur- or ers’ instructions, and utensils and

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equipment placed in the machine shall tergent wash and clean rinse waters be exposed to all dishwashing cycles. and that permits free draining. Automatic detergent dispensers, wet- (G) Machines (single-tank, station- ting agent dispensers, and liquid sani- ary-rack, door-type machines and tizer injectors, if any, shall be properly spray-type glass washers) using chemi- installed and maintained. cals for sanitization may be used: Pro- (B) The pressure of final rinse water vided, That, supplied to spray-type dishwashing ma- (1) The temperature of the wash chines shall not be less than 15 nor water shall not be less than 120 °F. more than 25 pounds per square inch (2) The wash water shall be kept measured in the water line imme- clean. diately adjacent to the final rinse con- (3) Chemicals added for sanitization trol valve. A 1⁄4–inch IPS valve shall be purposes shall be automatically dis- provided immediately up stream from pensed. the final rinse control valve to permit (4) Utensils and equipment shall be checking the flow pressure of the final exposed to the final chemical sanitiz- rinse water. ing rinse in accordance with manufac- (C) Machine or water line mounted turers’ specifications for time and con- numerically scaled indicating ther- centration. mometers, accurate to ≤3 °F, shall be (5) The chemical sanitizing rinse provided to indicate the temperature of water temperature shall be not less the water in each tank of the machine than 75 °F nor less than the tempera- and the temperature of the final rinse ture specified by the machine’s manu- water as it enters the manifold. facturer. (D) Rinse water tanks shall be pro- (6) Chemical sanitizers used shall tected by baffles, curtains, or other ef- meet the requirements of 21 CFR fective means to minimize the entry of 178.1010. wash water into the rinse water. Con- (7) A test kit or other device that ac- veyors in dishwashing machines shall curately measures the parts per mil- be accurately timed to assure proper lion concentration of the solution shall exposure times in wash and rinse cy- be available and used. cles in accordance with manufacturers’ (H) Machines using hot water for specifications attached to the ma- sanitizing may be used provided that chines. wash water and pumped rinse water (E) Drain boards shall be provided shall be kept clean and water shall be maintained at not less than the follow- and be of adequate size for the proper ing temperatures: handling of soiled utensils prior to washing and of cleaned utensils follow- (1) Single-tank, stationary-rack, ing sanitization and shall be so located dual-temperature machine: and constructed as not to interfere Wash temperature ...... 150 °F with the proper use of the dishwashing Final rinse temperature ...... 180 °F facilities. This does not preclude the use of easily movable dish tables for (2) Single-tank, stationary-rack, sin- the storage of soiled utensils or the use gle-temperature machine: of easily movable dishtables for the Wash temperature ...... 165 °F storage of clean utensils following Final rinse temperature ...... 165 °F sanitization. (3) Single-tank, conveyor machine: (F) Equipment and utensils shall be flushed or scraped and, when necessary, Wash temperature ...... 160 °F soaked to remove gross food particles Final rinse temperature ...... 180 °F and soil prior to being washed in a (4) Multitank, conveyor machine: dishwashing machine unless a prewashcycle is a part of the dishwash- Wash temperature ...... 150 °F ing machine operation. Equipment and Pumped rinse temperature ...... 160 °F ° utensils shall be placed in racks, trays, Final rinse temperature ...... 180 F or baskets, or on conveyors, in a way (5) Single-tank, pot, pan, and utensil that food-contact surfaces are exposed washer (either stationary or moving- to the unobstructed application of de- rack):

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Wash temperature ...... 140 °F forded an opportunity for a hearing Final rinse temperature ...... 180 °F with respect to the disputed fact, in ac- (I) All dishwashing machines shall be cordance with rules of practice which thoroughly cleaned at least once a day shall be adopted for the proceeding. or more often when necessary to main- However, such withdrawal or modifica- tain them in a satisfactory operating tion shall become effective pending condition. final determination in the proceeding (iii) Steam. Steam used in contact when the Administrator determines with food or food-contact surfaces shall that an imminent threat to food safety be free from any materials or additives or public health exists, and that such other than those specified in 21 CFR action is, therefore, necessary to pro- 173.310. tect the public health, interest or safe- (4) For purposes of this paragraph, ty. Such withdrawal or modification the term ‘‘private nonprofit institu- shall be effective upon oral or written tion’’ means ‘‘a corporation, and any notification, whichever is earlier, to community chest, fund, or foundation, the owner or operator of the particular organized and operated exclusively for establishment as promptly as cir- religious, charitable, scientific, testing cumstances permit. In the event of oral for public safety, literary, or edu- notification, written confirmation cational purposes, or to foster national shall be given to the owner or operator or international amateur sports com- of the establishment as promptly as petition (but only if no part of its ac- circumstances permit. This withdrawal tivities involve the provision of ath- or modification shall continue in effect letic facilities or equipment), or for the ending the completion of the proceed- prevention of cruelty to children or ing and any judicial review thereof, un- animals, no part of the net earnings of less otherwise ordered by the Adminis- which inures to the benefit of any pri- trator. vate shareholder or individual, no sub- (f) The adulteration and misbranding stantial part of the activities of which provisions of the Act and the regula- is carrying on propaganda, or other- tions in this subchapter, other than the wise attempting, to influence legisla- requirement of the official inspection tion, and which does not participate in, legend, apply to articles which are ex- or intervene in (including the publish- empted from inspection or not required ing or distribution of statements), any to be inspected under this section. This political campaign on behalf of (or in includes the requirement that any pork opposition to) any candidate for public and any product containing pork be office.’’ prepared only in compliance with any (5) The Administrator may withdraw applicable requirement for the destruc- or modify the exemption set forth in tion of trichina as provided in § 318.10 of § 303.1(e)(1) for a particular establish- this subchapter. ment when he or she determines that (g) The Administrator may extend such action is necessary to ensure food the requirements of titles I and IV of safety and public health. Before such the Act to any establishment in any action is taken, the owner or operator State or organized Territory at which of the particular establishment shall be products are prepared for distribution notified, in writing, of the reasons for solely within such jurisdiction, if he the proposed action and shall be given determines in accordance with the pro- an opportunity to respond, in writing, visions of paragraph 301(c)(1) of the Act to the Administrator within 20 days that it is producing adulterated prod- after notification of the proposed ac- ucts which would clearly endanger the tion. The written notification shall be public health. served on the owner or operator of the (h) The Administrator may in spe- establishment in the manner pre- cific classes of cases waive for limited scribed in section 1.147(b) of the De- periods any provisions of the regula- partment’s Uniform Rules of Practice tions in this subchapter in order to per- (7 CFR 1.147(b)). In those instances mit appropriate and necessary action where there is conflict of any material in the event of a public health emer- fact, the owner or operator of the es- gency or to permit experimentation so tablishment, upon request, shall be af- that new procedures, equipment, and/or

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processing techniques may be tested to evaluations of the performance and the facilitate definite improvements: Pro- characteristics and such establish- vided, That such waivers of the provi- ments. sions of such regulations are not in (1) In assessing the performance of an conflict with the purposes or provisions establishment, the following factors of the Act. are appropriate for consideration: (Approved by the Office of Management and (i) The history of compliance with Budget under control number 0583–0015) applicable regulatory requirements by [35 FR 15558, Oct. 3, 1970, as amended at 36 FR the person conducting operations at 12002, 12004, June 24, 1971; 45 FR 27922, Apr. 25, such establishment or by anyone re- 1980; 46 FR 46288, Sept. 18, 1981; 47 FR 746, sponsibly connected with the business Jan. 7, 1982; 51 FR 29909, Aug. 21, 1986; 52 FR conducting operations at such estab- 10032, Mar. 30, 1987; 52 FR 48091, Dec. 18, 1987; lishment, as ‘‘responsibly connected’’ 53 FR 24679, June 30, 1988; 57 FR 34182, Aug. is defined in section 401(g) of the Act, 3, 1992] (ii) The competence of the person § 303.2 Experimentation: Intensity of conducting operations at such estab- inspection coverage. lishment, as indicated by: (a) Pursuant to the Processed Prod- (A) Knowledge of appropriate manu- ucts Inspection Improvement Act of facturing practices and applicable reg- 1986, Title IV of the Futures Trading ulatory requirements, Act of 1986 (Pub. L. 99–641), in estab- (B) Demonstrated ability to apply lishments preparing products at which such knowlege in a timely and consist- inspection under the Act and regula- ent manner, and tions is required, the frequency with (C) Commitment to correcting defi- which and the manner in which meat ciencies noted by Program employees food products made from livestock pre- and otherwise assuring compliance viously slaughtered in official estab- with applicable regulatory require- lishments are examined and inspected ments, and by Program employees is to be based (iii) The procedures used in such es- on considerations relevant to effective tablishment to control the production regulation of meat food products and process, environment, and resulting protection of the health and welfare of product in order to assure and monitor consumers. In order to test procedures compliance with the requirements of for use in making such determinations the Act and the rules and regulations and, in particular, for determining promulgated thereunder. whether and, is so, to what extent the (2) In assessing the characteristics of intensity of inspection coverage ex- an establishment, the following factors ceeds that which should be considered are appropriate for consideration: necessary pursuant to section 6 of the (i) The complexity of the processing Act, as amended by section 403(a) of operation(s) conducted at such estab- the Futures Trading Act of 1986, the lishment, Administrator is initiating experimen- (ii) The frequency with which each tation of a new system of inspection such operation is conducted at such es- for reviewing the performance of estab- tablishment, lishments and for designing the supervision and other conditions and meth- (iii) The volume of product resulting ods of inspection coverage. For the pe- from each such operation at such es- riod of such experimentation, the Ad- tablishment, ministrator shall identify establish- (iv) Whether and to what extent ments for review, and the frequency slaughter operations also are con- and the manner of inspection by Pro- ducted at such establishment, gram employees shall be determined on (v) What, if any, food products not the basis of the results of those reviews regulated under this Act or the Poultry and be otherwise in accordance with Products Inspection Act also are pre- this section. pared at such establishment, and (b) The determinations referred to in (vi) The size of such establishment. paragraph (a) of this section shall be (c)(1) For the period of experimen- made by the program and shall reflect tation described in paragraph (a) of

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this section, the frequency of inspec- PART 304—APPLICATION FOR IN- tion by Program employees of oper- SPECTION; GRANT OR REFUSAL ations other than slaughter may be re- OF INSPECTION duced in an establishment in which the procedures referred to therein are Sec. being tested if and only if the evalua- 304.1 Application for inspection. tion of the performance of such estab- 304.2 Drawings, information to be furnished; lishment described in paragraph (b)(1) grant or refusal of inspection. indicates that there are: 304.3 Conditions for receiving inspection. (i) No instances, documented in AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, records compiled no earlier than 10 2.53. years before, of substantial and recent § 304.1 Application for inspection. noncompliance with applicable regu- (a) Before the inspection is granted, latory requirements (taking into ac- each person conducting operations at count both the nature and frequency of an establishment subject to the Act, any such noncompliance), and whether tenant, subsidiary, or land- (ii) The competence and control pro- lord, shall make application therefor cedures needed to assure and monitor to the Administrator as provided for in compliance with applicable regulatory this part. requirements. (b) Every application under this sec- (2) (i) The frequency of Federal in- tion shall be made on an official form spection and other conditions and furnished by the Program, available methods of inspection coverage in any from any Regional Director identified establishment in which the frequency in § 301.2(kkk) of this subchapter, and of Federal inspection is reduced shall shall be completed to include all infor- be based on: mation requested. Trade names of the (A) The evaluation of the character- applicant for labeling purposes, shall istics of such establishment described be inserted in the appropriate blank in the application. Each applicant for in- in paragraph (b)(2) of this section,1 spection will be held responsible for (B) The significance of potential pub- compliance with the Act and the regu- lic health consequences of noncompli- lations in this subchapter if inspection ance, and is granted. Preparation of product and (C) The availability of Program em- other operations at the establishment ployees. for which inspection is granted may be (ii) To the extent that such frequency conducted only by the applicant named of inspection or other conditions and in the application. methods of inspection coverage are (c) In cases of change of ownership or identified as conflicting with provi- location, a new application shall be sions of the regulations in this sub- made. chapter, the Administrator will waive [40 FR 2575, Jan. 14, 1975, as amended at 53 such provisions for the period of experi- FR 49848, Dec. 12, 1988] mentation, in accordance with § 303.1(g) of this subchapter. § 304.2 Drawings, information to be furnished; grant or refusal of in- [52 FR 10032, Mar. 30, 1987 and 52 FR 48091, spection. Dec. 18, 1987] (a) Each applicant for inspection shall submit to the Program: (1) Two sets of complete drawings 1 These evaluations will be based upon containing: the floor plans of the estab- guidelines developed by FSIS and the com- lishment for which inspection is re- plexity categorization in FSIS Directive 1030.2 (Documentation of Processing and quested, showing the locations of prin- Combination Assignments, 4/22/85). The cipal pieces of equipment, floor drains, guidelines and Directive will be available for principal drainage lines, handwashing public inspection and copying in the Policy basins, and hose connections for clean- Office, Room 3168, South Agriculture Build- up purposes; a plot plan showing limits ing, 14th Street and Independence Avenue, of the establishment’s premises, loca- SW., Washington, DC. tions in outline of buildings on the

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premises, cardinal points of the com- unless such certification has been ob- pass, and roadways and railways serv- tained, or is waived because of failure ing the establishment; and a room or refusal of the State, interstate agen- schedule showing the finish of walls, cy or the Secretary of the Interior to floors, and ceilings of all rooms in the act on a request for certification with- establishment. in a reasonable period (which shall not (2) Four sets of specifications, which exceed 1 year after receipt of such re- shall include statements describing the quest). water supply, plumbing, drainage, re- (2) However, certification is not ini- frigeration, equipment, lighting, and tially required in connection with an operations of the establishment related application for inspection granted after to sanitation and proper performance April 3, 1970, for facilities existing or of inspection. Applicants for inspection under construction on April 3, 1970, al- may request information from the Ad- though certification for such facilities ministrator concerning the require- is required to be obtained within the 3- ments before submitting drawings and year period immediately following other documents required by this para- April 3, 1970. Failure to obtain such graph. certification and meet the other re- (b) Notice in writing shall be given to quirements of subsection 21(b) prior to each applicant granted inspection, April 3, 1973, will result in the termi- specifying the establishment to which nation of inspection at such facilities the grant applies. on that date. (c) The Administrator is authorized to grant inspection upon his deter- Further, any application for inspection mination that the applicant and the es- pending on April 3, 1970, and granted tablishment are eligible therefor and within 1 year thereafter shall not re- to refuse to grant inspection at any es- quire certification for 1 year following tablishment if he determines that it the grant of inspection but such grant does not meet the requirements of this of inspection shall terminate at the part or the regulations in parts 305, 307, end of 1 year after its issuance unless and 308 of this subchapter or that the prior thereto such certification has applicant has not received approval of been obtained and the other require- labeling and containers to be used at ments of subsection 21(b) are met. the establishment as required by the (f) Inspection may be refused in ac- regulations in parts 316 and 317 of this cordance with humane slaughter and subchapter. When inspection is refused handling provisions of the Act (21 for any reason, the applicant shall be U.S.C. 603(b)) and the applicable rules informed of the action and the reasons of practice. therefor and afforded an opportunity to present his views. [35 FR 15558, Oct. 3, 1970, as amended at 41 FR (d) Inspection may also be refused in 4889, Feb. 3, 1976; 44 FR 68813, Nov. 30, 1979] accordance with section 401 of the Act § 304.3 Conditions for receiving in- and the applicable rules of practice. spection. (e)(1) Any applicant for inspection at an establishment where the operations (a) Before being granted Federal in- thereof may result in any discharge spection, an establishment shall have into the navigable waters in the United developed written sanitation Standard States is required by subsection 21(b) of Operating Procedures, as required by the Federal Water Pollution Control part 416 of this chapter. Act, as amended (84 Stat. 91), to pro- (b) Before being granted Federal in- vide the Administrator with a certifi- spection, an establishment shall have cation as prescribed in said subsection conducted a hazard analysis and devel- that there is reasonable assurance that oped and validated a HACCP plan, as such activity will be conducted in a required by §§ 417.2 and 417.4 of this manner which will not violate the ap- chapter. A conditional grant of inspec- plicable water quality standards. No tion shall be issued for a period not to grant of inspection can be issued after exceed 90 days, during which period the April 3, 1970 (the date of enactment of establishment must validate its the Water Quality Improvement Act), HACCP plan.

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(c) Before producing new product for responsible for compliance with the distribution in commerce, an establish- Act and regulations in their own estab- ment shall have conducted a hazard lishments, which shall include common analysis and developed a HACCP plan areas, e.g., hallways, stairways, and applicable to that product in accord- elevators. ance with § 417.2 of this chapter. During a period not to exceed 90 days after the [35 FR 15559, Oct. 3, 1970, as amended at 40 FR 2576, Jan. 14, 1975] date the new product is produced for distribution in commerce, the estab- § 305.2 Separation of official establish- lishment shall validate its HACCP ments. plan, in accordance with § 417.4 of this chapter. (a) Each official establishment shall be separate and distinct from any unof- [61 FR 38864, July 25, 1996] ficial establishment except a poultry products processing establishment op- PART 305—OFFICIAL NUMBERS; IN- erated under Federal inspection under AUGURATION OF INSPECTION; the Poultry Products Inspection Act or WITHDRAWAL OF INSPECTION; under State inspection. REPORTS OF VIOLATION (b) The slaughter or other preparation of products of horses, mules, or Sec. other equines required to be conducted 305.1 Official numbers; subsidiaries and ten- under inspection pursuant to the regu- ants. lations in this subchapter shall be done 305.2 Separation of official establishments. in establishments separate from any 305.3 Sanitation and adequate facilities. establishment in which cattle, sheep, 305.4 Inauguration of inspection. 305.5 Withdrawal of inspection; statement swine, or goats are slaughtered or their of policy. products are prepared. 305.6 Reports of violations. (c) Inspection shall not be inaugurated in any building, any part of AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. which is used as living quarters, unless the part for which inspection is re- SOURCE: 35 FR 15559, Oct. 3, 1970, unless quested is separated from such quar- otherwise noted. ters by floors, walls, and ceilings of § 305.1 Official numbers; subsidiaries solid concrete, brick, wood, or similar and tenants. material, and the floors, walls, and (a) An official number shall be as- ceilings are without openings that di- signed to each establishment granted rectly or indirectly communicate with inspection. Such number shall be used any part of the building used as living to identify all inspected and passed quarters. products prepared in the establish- § 305.3 Sanitation and adequate facili- ment. More than one number shall not ties. be assigned to an establishment. (b) Two or more official establish- Inspection shall not be inaugurated if ments under the same ownership or an establishment is not in a sanitary control may be granted the same offi- condition nor unless the establishment cial number, provided a serial letter is agrees to maintain a sanitary condi- added in each case to identify each es- tion and provides adequate facilities tablishment and the products thereof. for conducting such inspection. (c) When inspection has been granted to any applicant at an establishment, § 305.4 Inauguration of inspection. it shall not be granted to any other When inspection is granted, the cir- person at the same establishment. cuit supervisor shall, at or prior to the However, persons operating as separate inauguration of inspection, inform the entities in the same building or struc- operator of the establishment of the re- ture may operate separate establish- quirements of the regulations in this ments therein only under their own subchapter. If the establishment, at grant of inspection. All such persons the time inspection is inaugurated, operating separate establishments in contains any product which has not the same building or structure shall be theretofore been inspected, passed, and

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marked in compliance with the regula- (c) Inspection service may be tempo- tions in this subchapter, the identity of rarily suspended, in whole or in part, the same shall be maintained, and it at an official establishment, by the Ad- shall not be distributed in commerce, ministrator, to the extent that it is de- or otherwise subject to the require- termined necessary to prevent in-hu- ments of such regulations, or dealt mane slaughtering or handling in con- with as inspected and passed under the nection with slaughter of livestock as regulations. The establishment shall defined in § 301.2(kk) (9 CFR 301.2(kk)). adopt and enforce all necessary meas- The Administrator shall notify the op- ures and shall comply with all such di- erator of an establishment orally or in rections as the circuit supervisor may writing, as promptly as circumstances prescribe, for carrying out the purposes permit, of such suspension and the rea- of this section. sons therefor. Such suspension shall remain in effect until the operator of the § 305.5 Withdrawal of inspection; state- establishment takes effective steps to ment of policy. prevent a recurrence, or provides other (a) The Administrator is authorized satisfactory assurances that there will to withdraw inspection from an official not be any recurrences. Upon request, establishment where the sanitary con- the operator shall be afforded an oppor- ditions are such that its products are tunity for a hearing to show cause why rendered adulterated, or for failure of the suspension should be terminated. the operator to destroy condemned [38 FR 9794, Apr. 20, 1973, as amended at 44 products as required by the Act and the FR 68813, Nov. 30, 1979; 53 FR 49848, Dec. 12, regulations in this subchapter. Inspec- 1988] tion may be withdrawn in accordance with section 401 of the Act and the ap- § 305.6 Reports of violations. plicable rules of practice. Program employees shall report, in a (b) The assignment of inspectors may manner prescribed by the Adminis- be temporarily suspended, in whole or trator, all violations of the Act or reg- in part, by the Administrator to the ulations in this subchapter of which extent it is determined necessary to they have information. avoid impairment of the effective conduct of the program when the operator of any official establishment or any PART 306—ASSIGNMENT AND AU- subsidiary therein, or any officer, em- THORITIES OF PROGRAM EM- ployee, or agent of any such operator PLOYEES or any subsidiary therein, acting within the scope of his office, employment, Sec. or agency, threatens to forcibly assault 306.1 Designation of circuit supervisor and or forcibly assaults, intimidates, or assistants. interferes with any program employee 306.2 Program employees to have access to establishments. in or on account of the performance of 306.3 Badge as identification of inspectors. his official duties under the act, unless 306.4 Assignment of Program employees promptly upon the incident being where members of family employed; so- brought by an authorized supervisor of liciting employment; procuring product the program employee to the attention from official establishments. of the operator of the establishment 306.5 Appeals. the operator (1) satisfactorily justifies AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, the incident, (2) takes effective steps to 2.53. prevent a recurrence, or (3) provides ac- SOURCE: 35 FR 15559, Oct. 3, 1970, unless ceptable assurance that there will not otherwise noted. be any recurrences. Such suspension shall remain in effect until one of such § 306.1 Designation of circuit super- actions is taken by the operator: Pro- visor and assistants. vided, That upon request of the opera- The Administrator shall designate a tor he shall be afforded an opportunity circuit supervisor of the inspection in for an expedited hearing to show cause each circuit, and assign to said inspec- why the suspension should be termi- tor such assistants as may be nec- nated. essary.

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§ 306.2 Program employees to have ac- partment unless the store or outlet cess to establishments. from which the purchase is made is For the purpose of any examination open to the general public and the or inspection necessary to prevent the price paid by such employee is the use in commerce of any adulterated same as the price paid by the general product, Program employees shall have public. Program employees must pay, access at all times, by day or night, and obtain receipts for money paid to whether the establishment is operated such establishments for all such prod- or not, to every part of any official es- uct and keep such receipts subject to tablishment to which they are as- inspection by supervisory employees or other authorized Department employ- signed. Access to establishments is also ees. authorized in accordance with section 202 of the Act and the regulations in § 306.5 Appeals. part 320 of this subchapter. Any appeal from a decision of any § 306.3 Badge as identification of in- Program employee shall be made to spectors. his/her immediate supervisor having Each inspector will be furnished with jurisdiction over the subject matter of a numbered official badge, which he the appeal, except as otherwise provided in the applicable rules of prac- shall not allow to leave his possession, tice. and which he shall wear in such manner and at such times as the Adminis- [48 FR 11418, Mar. 18, 1983, as amended at 60 trator may prescribe. This badge shall FR 67454, Dec. 29, 1995] be sufficient identification to entitle him to admittance at all regular en- PART 307—FACILITIES FOR trances and to all parts of the estab- INSPECTION lishment and premises to which he is assigned. Sec. 307.1 Facilities for Program employees. § 306.4 Assignment of Program em- 307.2 Other facilities and conditions to be ployees where members of family provided by establishment. employed; soliciting employment; 307.3 Inspectors to furnish implements and procuring product from official es- maintain hands and implements in sani- tablishments. tary condition. (a) Except as specifically authorized 307.4 Schedule of operations. 307.5 Overtime and holiday inspection serv- by the Administrator, no Program em- ice. ployee shall be detailed for duty at an 307.6 Basis of billing for overtime and holi- establishment where any member of day services. his family is employed by the operator 307.7 Safety requirements for electrical of the establishment, or any tenant or stimulating (EST) equipment. subsidiary of such operator nor shall AUTHORITY: 7 U.S.C. 394, 21 U.S.C. 601–695; 7 any circuit supervisor or other em- CFR 2.17, 2.55. ployee acting in a supervisory capacity SOURCE: 35 FR 15560, Oct. 3, 1970, unless be continued on duty at a circuit where otherwise noted. any member of his family is so employed at any establishment under his § 307.1 Facilities for Program employ- jurisdiction. Program employees are ees. forbidden to solicit, for any person, em- Office space, including necessary fur- ployment at any official establish- nishings, light, heat, and janitor serv- ment, or by any officer, manager, or ice, shall be provided by official estab- employee thereof. lishments, rent free, for the exclusive (b) Program employees shall not pro- use for official purposes of the inspec- cure product from any official estab- tor and other Program employees as- lishment or any other establishment if signed thereto. The space set aside for its operations or products are inspected this purpose shall meet with approval or regulated under the Poultry Prod- of the circuit supervisor and shall be ucts Inspection Act or the Agricultural conveniently located, properly venti- Marketing Act of 1946, as amended, or lated and provided with lockers suit- any other law administered by the De- able for the protection and storage of

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Program supplies and with facilities (e) Watertight metal trucks or recep- suitable for Program employees to tacles for holding and handling dis- change clothing if such clothes chang- eased carcasses and parts, so con- ing facilities are deemed necessary by structed as to be readily cleaned; such the circuit supervisor. At the discre- trucks or receptacles to be marked in a tion of the Administrator, small plants conspicuous manner with the phrase requiring the services of less than one ‘‘U.S. condemned’’ in letters not less full time inspector need not furnish fa- than 2 inches high, and, when required cilities for Program employees as pre- by the circuit supervisor, to be scribed in this section, where adequate equipped with facilities for locking or facilities exist in a nearby convenient sealing; location. Laundry service for inspec- (f) Adequate arrangements, including tors’ outer work clothing shall be pro- liquid soap and cleansers, for cleansing vided by each establishment. and disinfecting hands, for sterilizing all implements used in dressing dis- § 307.2 Other facilities and conditions eased carcasses, floors, and such other to be provided by establishment. articles and places as may be contami- When required by the circuit super- nated by diseased carcasses or other- visor, the following facilities and con- wise; ditions, and such others as may be (g) In establishments in which found to be essential to efficient con- slaughtering is done, rooms, compart- duct of inspection and maintenance of ments, or specially prepared open sanitary conditions, shall be provided places, to be known as ‘‘final inspec- by each official establishment: tion places,’’ at which the final inspection of retained carcasses may be con- (a) Satisfactory pens, equipment, and ducted (competent assistants for han- assistants for conducting ante-mortem dling retained carcasses and parts shall inspection and for separating, marking be provided by the establishment; final and holding apart from passed live- inspection places shall be adequate in stock those marked ‘‘U.S. suspect’’ and size and their rail arrangement and those marked ‘‘U.S. condemned’’ (pens, other equipment shall be sufficient to alleys, and runways shall be paved, prevent carcasses and parts passed for drained, and supplied with adequate food or cooking, from being contami- hose connections for cleanup purposes); nated by contact with condemned car- (b) Sufficient light to be adequate for casses or parts; they shall be equipped proper conduct of inspection; with hot water, lavatory, sterilizer, ta- (c) Racks, receptacles, or other suit- bles, and other equipment required for able devices for retaining such parts as ready, efficient, and sanitary conduct the head, tongue, tail, thymus gland, of the inspection; the floors shall be of and viscera, and all parts and blood to such construction as to facilitate the be used in the preparation of meat food maintenance of sanitary conditions products or medical products, until and shall have proper drainage connec- after the post-mortem examination is tions, and when the final inspection completed, in order that they may be place is part of a larger floor, it shall identified in case of condemnation of be separated from the rest of the floor the carcass; equipment, trucks, and re- by a curb, railing, or otherwise); ceptacles for the handling of viscera of (h) Retention rooms, cages, or other slaughtered animals so as to prevent compartments, and receptacles in contact with the floor; and trucks, which carcasses and product may be racks, marked receptacles, tables, and held for further inspection (these shall other necessary equipment for the sep- be in such number and in such loca- arate and sanitary handling of car- tions as the needs of the inspection in casses or parts passed for cooking; the establishment may require; they (d) Tables, benches, and other equip- shall be equipped for secure locking or ment on which inspection is to be per- sealing and shall be held under locks or formed, of such design, material, and official seals furnished by the Depart- construction as to enable Program em- ment; the keys of such locks shall not ployees to conduct their inspection in a leave the custody of Program employ- ready, efficient and clean manner; ees. Every such room, compartment, or

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receptacle shall be marked conspicu- with soap, towels, and hot and cold ously with the phrase ‘‘U.S. retained’’ water, and located adjacent to the in- in letters not less than 2 inches high; spector’s work area. In addition, for rooms or compartments for these pur- each head and viscera inspector on cat- poses shall be secure and susceptible of tle slaughter lines, and each head in- being kept clean, including a sanitary spector on swine slaughter lines, a disposal of the floor liquids; establish- sterilizer located adjacent to the in- ment employees shall not enter any re- spector’s work area. tention rooms or compartments or (4) For mechanized operations, a line open any retention receptacles unless control switch located adjacent to each authorized by Program employees); inspection station. (i) Adequate facilities, including de- (5) Facilities to position tally sheets naturing materials, for the proper dis- or other recording devices, such as dig- posal of condemned articles in accord- ital counters, and facilities to contain ance with the regulations in this sub- condemned brands. chapter (tanks or other rendering (6) For swine slaughter lines requir- equipment which, under the regula- ing three or more inspectors, and for tions in this subchapter, must be those one- and two-inspector configura- sealed, shall be properly equipped for tions where the establishment installs sealing as specified by the regulations a mirror: At the carcass inspection sta- in Part 314 of this subchapter or by the tion one glass or plastic, distortion- circuit supervisor in specific cases); free mirror, at least 5 feet × 5 feet, (j) Docks and receiving rooms, to be mounted far enough away from the ver- designated by the operator of the offi- tical axis of the moving line to allow cial establishment, with the circuit su- the carcass to be turned, but not over pervisor, for the receipt and inspection 3 feet away, and so mounted that any of all products as provided in § 318.3 of inspector standing at the carcass in- this subchapter. spection station can readily view the (k) Suitable lockers in which brands back of the carcass. bearing the official inspection legend and other official devices (excluding la- [35 FR 15560, Oct. 3, 1970, as amended at 47 FR bels) and official certificates shall be 33676, Aug. 4, 1982; 50 FR 19902, May 13, 1985] kept when not in use (all such lockers § 307.3 Inspectors to furnish imple- shall be equipped for sealing or locking ments and maintain hands and im- with locks or seals to be supplied by plements in sanitary condition. the Department; the keys of such locks shall not leave the custody of Program Inspectors shall furnish their own employees); work clothing and implements, such as (l) Sanitary facilities and accom- flashlights and triers, for conducting modations as prescribed by § 308.4 of inspection and shall cleanse their this subchapter. hands and implements as prescribed by (m) In addition to any facilities re- § 308.8 of this subchapter. quired to accomplish sanitary dressing procedures, the following inspection § 307.4 Schedule of operations. station facilities for cattle and swine (a) No operations requiring inspec- slaughter lines described in § 310.1(b) of tion shall be conducted except under this subchapter are required: the supervision of a Program employee. (1) An inspection station consisting All slaughtering of animals and prepa- of 5 feet of unobstructed line space for ration of products shall be done with each head or carcass inspector and, for reasonable speed, considering the offi- viscera table kills, 8 feet for each cial establishment’s facilities. viscera inspector on the inspector’s (b) A shift is a regularly scheduled side of the table. operating period, exclusive of meal- (2) A minimum of 50 foot candles of time. One lunch period is the only offi- shadow-free lighting at the inspection cial authorized interruption in the in- surfaces of the head, viscera, and car- spector’s tour of duty once it begins. cass. Lunch periods may be 30 minutes, 45 (3) A handwash lavatory (other than minutes, or in any case may not exceed one which is hand operated), furnished one hour in duration. Once established,

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the lunch period must remain rel- to the area supervisor at least 2 weeks atively constant as to time and dura- in advance of the proposed change. Fre- tion. Lunch periods for inspectors shall quent requests for change shall not be not, except as provided herein, occur approved: Provided, however, minor de- prior to 4 hours after the beginning of viations from a daily operating sched- scheduled operations nor later than 5 ule may be approved by the inspector hours after operations begin. In plants in charge, if such request is received on where a company rest break of not less the day preceding the day of change. than 30 minutes is regularly observed, (3) Request for inspection service approximately midpoint between start outside an approved work schedule of work and the lunch period, and the shall be made as early in the day as inspector is allowed this time to meet possible for overtime work to be per- his personal needs, the lunch period formed within that same workday; or may be scheduled as long as 51⁄2 hours made prior to the end of the day’s oper- after the beginning of scheduled operation when such a request will result in ations. overtime service at the start of the fol- (c) Official establishments, import- lowing day: Provided, That an inspector ers, and exporters shall be provided in- may be recalled to his assignment after spection service, without charge, up to completion of his daily tour of duty 8 consecutive hours per shift during the under the provisions of § 307.6(b). basic workweek subject to the provi- [40 FR 45799, Oct. 3, 1975, as amended at 40 FR sions of § 307.5: Provided, That any addi- 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; tional shifts meet requirements as de- 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, termined by the Administrator or his 1986] designee. The basic workweek shall consist of 5 consecutive 8-hour days § 307.5 Overtime and holiday inspec- within the administrative workweek tion service. Sunday through Saturday, excluding (a) The management of an official es- the lunch period; except that, when tablishment, an importer, or an ex- possible, the Department shall sched- porter shall reimburse the Program, at ule the basic workweek so as to consist the rate specified in § 391.3, for the cost of 5 consecutive 8-hour days Monday of the inspection service furnished on through Friday, excluding lunch pe- any holiday as specified in paragraph riod. The Department may depart from (b) of this section; or for more than 8 the basic workweek in those cases hours on any day, or more than 40 where maintaining such a schedule hours in any administrative workweek would seriously handicap the Depart- Sunday through Saturday. ment in carrying out its function. (b) Holidays for Federal employees These provisions are applicable to all shall be New Year’s Day, January 1; official establishments except in cer- Birthday of Martin Luther King, Jr., tain cases as provided in § 318.4(h) of the third Monday in January; Washing- this subchapter. ton’s Birthday, the third Monday in (d)(1) Each official establishment February; Memorial Day, the last Mon- shall submit a work schedule to the day in May; Independence Day, July 4; area supervisor for approval. In consid- Labor Day, the first Monday in Sep- eration of whether the approval of an tember; Columbus Day, the second establishment work schedule shall be Monday in October; Veterans’ Day, No- given, the area supervisor shall take vember 11; Thanksgiving Day, the into account the efficient and effective fourth Thursday in November; Christ- use of inspection personnel. The work mas Day, December 25. When any of schedule must specify daily clock the above-listed holidays falls outside hours of operation and lunch periods the basic workweek, the nearest work- for all departments of the establish- day within that week shall become a ment requiring inspection. holiday. (2) Establishments shall maintain [40 FR 45800, Oct. 3, 1975, as amended at 43 FR consistent work schedules. Any request 51754, Nov. 7, 1978; 50 FR 724, Jan. 7, 1985; 50 by an establishment for a change in its FR 51513, Dec. 18, 1985; 52 FR 4, Jan. 2, 1987; work schedule involving an addition or 53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, elimination of shifts shall be submitted 1989]

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§ 307.6 Basis of billing for overtime ment as set forth in § 308.5 of this sub- and holiday services. chapter. (a) Each recipient of overtime or hol- (b) Safety requirements—(1) Circuits, iday inspection service, or both, shall grounding. Either a bonded grounding be billed as provided for in § 307.5(a) and conductor shall lead from each section at the rates specified in § 391.3, in incre- of the carcass rail within the stimulat- ments of quarter hours. For billing ing enclosure to the service ground, or purposes, 8 or more minutes shall be the secondary voltage (stimulating cir- considered a full quarter hour. Billing cuit) shall be insulated from the serv- will be for each quarter hour of service ice ground. If the stimulating section rendered by each Program employee. of the carcass rail and carcass drive (b) Official establishments, import- mechanisms are insulated from the ers, or exporters requesting and receiv- service ground then the stimulating ing the services of a Program employee rail or the return path shall be elec- after he has completed his day’s assign- trically bonded to the transformer sec- ment and left the premises, or called ondary to isolate the stimulation volt- back to duty during any overtime or age. holiday period, shall be billed for a (2) Enclosure. Electrical stimulation minimum of 2 hours overtime or holi- shall occur in an area that will prevent day inspection service at the estab- persons from contacting an energized lished rate. surface. If the area is surrounded by physical barriers, the enclosure shall (c) Bills are payable upon receipt and be either electrically grounded or it become delinquent 30 days from the shall be made of materials that do not date of the bill. Overtime or holiday in- conduct electricity. The interior of the spection will not be performed for any- stimulating area shall be visible from one having a delinquent account. the start switch so the operator can be [40 FR 45800, Oct. 3, 1975, as amended at 54 FR assured that there is no person, equip- 6389, Feb. 10, 1989] ment or material present that should not be there prior to starting the stim- § 307.7 Safety requirements for elec- ulating sequence. If light or sound trical stimulating (EST) equipment. beam sensors form the enclosure, the (a) General. Electrical stimulating stimulating equipment shall be auto- (EST) equipment is equipment that matically shut off when the sensor sig- provides electric shock treatment to nals are broken. carcasses for the purpose of accelerat- (3) Mandatory Warning Devices and ing rigor mortis of facilitating blood Signals. The following warning devices removal. These provisions do not apply or signals shall be installed at each to electrical equipment used to stun opening to the stimulating area and/or slaughter animals or to facili- through which a person would nor- tate hide removal. Electrical stimulat- mally enter: ing equipment consists of two separate (i) A red light that flashes distinctly pieces—the control system and the ap- during the operating cycle of the stim- plicator. The EST control system con- ulating equipment. tains the circuitry to generate pulsed (ii) An ANSI Z53.1-Color Code sign DC or AC voltage for stimulation and reading (a) ‘‘Danger Electrical Hazard’’ is separate from the equipment used to for stimulating voltage below 50 or (b) apply the voltage to the carcass. The ‘‘Danger High Voltage’’ for stimulating voltage is applied by inserting a probe voltage above 50. that penetrates the carcass or is in- (iii) An emergency stop button. serted in the rectum, placing a clamp (4) Optional Warning Device—Horn or in the nose, a carcass rub-bar, a con- Bell. If a warning horn or bell is in- veyor with energized surfaces traveling stalled, the signal shall be audible with the carcass, or any other method above background noises in the vicin- found to be acceptable by the Adminis- ity, and it shall sound for at least 1 trator. The Administrator will evalu- second before each manual stimulation ate EST equipment to determine its ac- or before the carcass chain is started in ceptability for its proposed use before an automatic system. it is installed in an official establish- (c) Operation—

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(1) Training. Only persons who have 308.11 Burlap wrapping for meat. received safety instruction by the 308.12 Second-hand tubs, barrels, and other equipment manufacturer or designee containers. may operate electrical stimulating 308.13 Inedible operating and storage rooms; outer premises, docks, driveways, ap- equipment. proaches, pens, alleys, etc.; flybreeding (2) Cleaning and Maintenance. To pre- material; other conditions. vent an electrical shock to personnel, 308.14 Employment of diseased persons. the electricity supplied to the stimu- 308.15 Tagging insanitary equipment, uten- lating surfaces shall be locked-off when sils, rooms or compartments. cleaning, mechanical inspection, main- 308.16 Sanitation requirements for elec- tenance or testing are performed. trical stimulating (EST) equipment. (3) Water. To prevent an electrical AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, shock, personnel shall not spray 2.53. streams of water on energized car- SOURCE: 35 FR 15561, Oct. 3, 1970, unless casses or on energized stimulating sur- otherwise noted. faces. (d) Special provisions for manually § 308.1 Examination and specifications operated equipment. for equipment and sanitation prior (1) Stimulating probes or clamps to granting inspection. shall be stored in a sanitary container Prior to the inauguration of inspec- which is insulated with a material ap- tion, an examination of the establish- proved by the Administrator.1 ment and premises shall be made by a (2) The electric wires attached to a Program employee and the require- clamp or probe shall not allow for con- ments for sanitation and the necessary tact between the probe or clamp and an facilities for inspection shall be speci- electrical ground and shall not extend fied by him in accordance with the reg- outside the enclosure. ulations in this part and part 307 of [53 FR 46432, Nov. 17, 1988] this subchapter. § 308.2 Drawings and specifications to PART 308—SANITATION be furnished in advance of construction. Sec. Drawings and specifications as pre- 308.1 Examination and specifications for equipment and sanitation prior to grant- scribed in § 304.2 of this subchapter for ing inspection. remodeling any official establishment, 308.2 Drawings and specifications to be fur- or part thereof, and for any new struc- nished in advance of construction. tures to be used in an official establish- 308.3 Establishments; sanitary condition; ment, or part thereof, shall be submit- requirements. ted to the Administrator and approval 308.4 Sanitary facilities and accommoda- obtained for the plans in advance of tions; specific requirements. 308.5 Equipment and utensils to be easily construction. cleaned; those for inedible products to be [41 FR 4889, Feb. 3, 1976] so marked; evaluation of equipment and utensils; PCB-containing equipment. § 308.3 Establishments; sanitary condi- 308.6 Scabbards for knives. tion; requirements. 308.7 Rooms, compartments, etc., to be clean and sanitary. (a) Official establishments shall be 308.8 Operations, procedures, rooms, cloth- maintained in sanitary condition, and ing, utensils, etc., to be clean and sani- to this end the requirements of this tary. section shall be complied with. The 308.9 Protective handling of products. provisions of part 416 of this chapter 308.10 Slack barrels and similar containers also apply. and means of conveyance used for prod- (b) There shall be abundant light, of uct; paper in contact with product. good quality and well distributed, and sufficient ventilation for all rooms and 1 A list of approved insulation materials is compartments to insure sanitary con- available upon request from the Facilities, Equipment and Sanitation Division, Tech- dition. nical Services, Food Safety and Inspection (c) There shall be an efficient drain- Service, U.S. Department of Agriculture, age and plumbing system for the estab- Washington, DC 20250. lishment and premises, and all drains

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and gutters shall be properly installed (ii) All pipelines, reservoirs, tanks, with traps and vents approved by the cooling towers, and like equipment em- circuit supervisor. ployed in handling the reused water are (d)(1) The water supply shall be so constructed and installed so they ample, clean, and potable, with ade- can be cleaned and drained, and are quate facilities for its distribution in kept clean. the plant and its protection against (3) Approval for the reuse of water contamination and pollution. Every es- other than as specified in paragraph tablishment shall make known and, (d)(2) of this section or in § 318.305(h) whenever required by the circuit super- shall be obtained from the Adminis- visor, shall afford opportunity for in- trator in specific cases. spection of the source of its water sup- (4) An ample supply of water at not ° ply, the storage facilities, and the dis- less than 180 F. shall be furnished and tribution system. Equipment using po- used for the cleaning of inspection table water shall be so installed as to equipment and other equipment, floors, prevent back-siphonage into the pot- and walls which are subject to con- able water system. Nonpotable water is tamination by the dressing or handling permitted only in those parts of offi- of diseased carcasses, their viscera, and cial establishments where no edible other parts. Whenever necessary to de- product is handled or prepared, and termine compliance with this require- then only for limited purposes such as ment, conveniently located thermom- on ammonia condensers not connected eters shall be installed by the operator of the official establishment to show with the potable water supply, in vapor the temperature of the water at the lines serving inedible product render- point of use. ing tanks, in connection with equip- (5) Hot water for cleaning rooms and ment used for hashing and washing in- equipment other than those mentioned edible products preparatory to tanking, in paragraph (d)(4) of this section shall and in sewer lines for moving heavy be delivered under pressure to suffi- solids in the sewage. Nonpotable water cient convenient outlets and shall be of is not permitted for washing floors, such temperature as to accomplish a areas, or equipment involved in truck- thorough cleanup. ing materials to and from edible prod- (e) The floors, walls, ceilings, parti- uct departments nor is it permitted in tions, posts, doors, and other parts of hog scalding vats, dehairing machines, all structures shall be of such mate- or vapor lines serving edible product rials, construction, and finish as will rendering equipment, or for cleanup of make them susceptible of being readily shackling pens, bleeding areas, or run- and thoroughly cleaned. The floors ways within the slaughtering depart- shall be kept watertight. The rooms ment. In all cases, nonpotable and compartments used for edible prod- waterlines shall be clearly identified uct shall be separate and distinct from and shall not be cross-connected with those used for inedible product. the potable water supply unless this is (f) Rails should be located and pas- necessary for fire protection and such sageway space provided so that exposed connection is of a type with an ade- product does not come in contact with quate break to assure against acciden- posts, walls, and other fixed parts of tal contamination, and is approved by the building, or with barrels, boxes, local authorities and by the circuit su- and other containers trafficked pervisor. through holding and operating areas. (2) The circuit supervisor may permit Exposed product shall not be placed or the reuse of water in vapor lines lead- stored beneath carcasses in coolers or ing from deodorizers used in the prepa- holding areas. ration of lard and similar edible prod- (g) The rooms and compartments in uct and in equipment where such water which any product is prepared or han- is used to thermally process canned dled shall be free from dust and from product packed in hermetically sealed odors from dressing and toilet rooms, containers, provided: catch basins, hide cellars, casing (i) The reuse is for the identical rooms, inedible tank and fertilizer original purpose. rooms, and livestock pens.

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(h) Every practicable precaution and urinal rooms and also at such shall be taken to exclude flies, rats, other places in the establishment as mice, and other vermin from official may be essential to assure cleanliness establishments. The use of poisons for of all persons handling any product. any purpose in rooms or compartments (c) Toilet soil lines shall be separate where any unpacked product is stored from house drainage lines to a point or handled is forbidden, except under outside the building and drainage from such restrictions and precautions as toilet bowls and urinals shall not be are prescribed by the regulations in discharged into a grease catch basin. this part or by the circuit supervisor in (d) Properly located facilities shall specific cases. The use of insecticides, be provided for cleansing and disinfect- rodenticides, and similar pest control ing utensils and hands of all persons substances in hide cellars, inedible handling any product. product departments, outbuildings, or similar places, or in storerooms con- § 308.5 Equipment and utensils to be easily cleaned; those for inedible taining canned or tierced products is products to be so marked; evalua- not forbidden but only those approved tion of equipment and utensils; by the Administrator may be used. 1 PCB-containing equipment. So-called rat viruses shall not be used (a) Equipment and utensils used for in any part of an establishment or the preparing or otherwise handling any premises thereof. edible product or ingredient thereof in (i) Dogs and cats shall be excluded any official establishment shall be of from the interior of official establish- such material and construction as, in ments; however, dogs may be permitted the judgment of the Administrator, on the outer premises for guard pur- will facilitate their thorough cleaning poses. and insure cleanliness in the prepara- [35 FR 15561, Oct. 3, 1970, as amended at 51 FR tion and handling of all edible products 45619, Dec. 19, 1986; 61 FR 38864, July 25, 1996] and otherwise avoid adulteration and misbranding of such products. In addi- § 308.4 Sanitary facilities and accom- tion to these requirements, equipment modations; specific requirements. and utensils shall not in any way inter- Adequate sanitary facilities and ac- fere with or impede inspection proce- commodations shall be furnished by dures. Receptacles used for handling every official establishment. Of these, inedible material shall be of such ma- the following are specifically required: terial and construction that, in the (a) Dressing rooms, toilet rooms, and judgment of the Administrator, their urinals shall be sufficient in number, use will not result in adulteration of ample in size, and conveniently lo- any edible product or in insanitary cated. The rooms shall be provided conditions at the establishment, and with facilities to provide abundant they shall bear conspicuous and dis- light of good quality and well distrib- tinctive marking to identify them as uted. They shall be properly ventilated, only for such use and shall not be used and meet all requirements of the regu- for handling any edible product. lations in this part as to sanitary con- (b) When equipment or utensils for struction and equipment. They shall be use in preparing or handling product separate from the rooms and compart- are proposed for use in an official es- ments in which products are prepared, tablishment, the operator of the estab- stored, or handled. Where both sexes lishment shall so notify the Adminis- are employed, separate facilities shall trator, and thereafter shall submit to be provided. the Administrator such information as (b) Acceptable lavatories, including the Administrator specifies in each running hot and cold water, soap, and case as necessary to determine whether towels, shall be placed in or near toilet the equipment or utensils meet the criteria specified in paragraph (a) of this section. The required information shall 1 A list of approved pest control substances is available upon request to the Scientific include, but may not be limited to, as- Services, Meat and Poultry Inspection, Food sembly type drawings and a list show- Safety and Inspection Service, U.S. Depart- ing the materials of which parts are ment of Agriculture, Washington, DC 20250. made. The Administrator will evaluate

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the model of equipment or utensil and such equipment and machinery. To- determine whether it is acceptable for tally enclosed capacitors containing its proposed use under the criteria set less than 3 pounds of PCBs are exempt- forth in paragraph (a) of this section. ed from this prohibition. (c) The Administrator will, from time [40 FR 25439, June 16, 1975, as amended at 40 to time, prepare a listing by name and FR 60053, Dec. 31, 1975; 45 FR 68918, Oct. 17, model number of equipment and uten- 1980] sils that have been evaluated and found to be acceptable for their proposed use § 308.6 Scabbards for knives. in accordance with this section. A copy Scabbards and similar devices for the of such listing can be obtained from temporary retention of knives, steels, Technical Services, Meat and Poultry triers, etc., by workers and others at Inspection Program, Food Safety and official establishments shall be con- Inspection Service, U.S. Department of structed of rust-resisting metal or Agriculture, Washington, DC 20250. other impervious material, shall be of (d) The Administrator may dis- a type that may be readily cleaned, and approve for use in official establish- shall be kept clean. ments particular models of equipment or utensils that he finds do not meet § 308.7 Rooms, compartments, etc., to the requirements of paragraph (a) of be clean and sanitary. this section or that he cannot evaluate Rooms, compartments, places, equip- because of lack of sufficient informa- ment, and utensils used for preparing, tion. Further, he may prescribe such storing, or otherwise handling any conditions for the use of particular product, and all other parts of the es- models of equipment or utensils, either tablishment, shall be kept clean and in on a trial or permanent basis, as he sanitary condition. There shall be no finds necessary to prevent adulteration handling or storing of materials which or misbranding of product. create an objectionable condition in (e) Nothing in this section shall af- rooms, compartments, or places where fect the authority of Program inspec- any product is prepared, stored, or oth- tors to reject specific equipment or erwise handled. utensils under § 308.15 of the regulations in this subchapter. § 308.8 Operations, procedures, rooms, (f) Before approval of any model or clothing, utensils, etc., to be clean specific item of equipment or utensil is and sanitary. finally denied, or is granted only with (a) Operations and procedures involv- conditions, the applicant shall be given ing the preparation, storing, or han- notice and opportunity to present his dling of any product shall be strictly in views to the Administrator. If the ap- accord with clean and sanitary meth- plicant does not accept the Adminis- ods. trator’s determination, a hearing in ac- (b) Rooms and compartments in cordance with the applicable rules of which inspections are made and those practice will be held to resolve such in which livestock are slaughtered or dispute. This shall not preclude rejec- any product is prepared shall be kept tion of the equipment or utensils under sufficiently free of steam and vapors to § 308.15 or this section pending the out- enable Program employees to make in- come of the presentation of views or spections and to insure clean oper- hearing. ations. The walls, ceilings, and over- (g) New or replacement equipment or head structure of rooms and compart- machinery (including any replacement ments in which product is prepared, parts) brought onto the premises of handled, or stored shall be kept reason- any official establishment shall not ably free from moisture to prevent contain liquid polychlorinated dripping and contamination of product. biphenyls (PCBs) in concentrations (c) Butchers and others who dress or above 50 parts per million by weight of handle diseased carcasses or parts the liquid medium. This provision ap- shall, before handling or dressing other plies to both food processing and carcasses or parts, cleanse their hands nonfood processing equipment and ma- with liquid soap and hot water, and chinery, and any replacement parts for rinse them in clean water. Implements

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used in dressing diseased carcasses § 308.10 Slack barrels and similar con- shall be thoroughly cleansed with hot tainers and means of conveyance water having a minimum temperature used for product; paper in contact of 180 °F. or in a disinfectant 2 approved with product. by the Administrator, followed by rins- (a) When necessary to avoid contami- ing in clean water. The employees of nation of product with wood splinters the establishment who handle any or similar contaminants, slack barrels product shall keep their hands clean, and similar containers and the cargo and in all cases after visiting the toilet space of trucks, railroad cars, or other rooms or urinals shall wash their hands means of conveyance shall be lined before handling any product or imple- with suitable material of good quality ments used in the preparation of prod- before packing. uct. (b) Slack barrels and similar contain- (d) Aprons, frocks, and other outer ers and trucks, railroad cars, and other clothing worn by persons who handle means of conveyance in which any any product shall be of material that is product is transported shall be kept in readily cleansed. Clean garments shall a clean and sanitary condition. be worn at the start of each working (c) Paper used for covering or lining day and the garments shall be changed slack barrels and similar containers during the day when required by the and the cargo space of trucks, railroad inspector in charge. cars, or other means of conveyance (e) Such practices as spitting on shall be of a kind which does not tear whetstones; spitting on the floor; plac- during use but remains intact when ing skewers, tags, or knives in the moistened by the product and does not mouth; inflating lungs or casings with disintegrate. air from the mouth; or testing with air from the mouth such receptacles as § 308.11 Burlap wrapping for meat. tierces, kegs, or casks, containing or Since burlap used without any other intended as containers of any product, material as a wrapping for meat depos- are prohibited. Only mechanical means its lint on the meat and does not suffi- may be used for such testing. Care ciently protect it from outside con- shall be taken to prevent the contami- tamination, the use of burlap as a nation of product with perspiration, wrapping for meat will not be per- hair, cosmetics, medications, and simi- mitted unless the meat is first wrapped lar substances. with a good grade of paper or cloth of (f) Equipment or substances which a kind which will prevent contamina- generate gases or odors shall not be tion with lint or other foreign matter. used in official establishments except as permitted by the regulations in this § 308.12 Second-hand tubs, barrels, part or by the circuit supervisor in spe- and other containers. cific cases in which he determines that Second-hand tubs, barrels, and boxes such use will not result in adulteration intended for use as containers of any of any product. product shall be inspected when received at the official establishment and § 308.9 Protective handling of products. before they are cleaned. Those showing evidence of misuse rendering them Products shall be protected from con- unfit to serve as containers for food tamination from any source such as products shall be rejected. The use of dust, dirt, or insects during storage, those showing no evidence of previous loading, or unloading at and transpor- misuse may be allowed after they have tation from official establishments. been thoroughly and properly cleaned. Steaming, after thorough scrubbing 2 A list of approved disinfectants is avail- and rinsing, is essential to cleaning able upon request to the Scientific Services, tubs and barrels. Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department of [35 FR 15561, Oct. 3, 1970, as amended at 38 FR Agriculture, Washington, DC 20250. 29214, Oct. 23, 1973; 41 FR 23700, June 11, 1976]

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§ 308.13 Inedible operating and stor- ment so tagged shall again be used age rooms; outer premises, docks, until made acceptable. Such tag so at- driveways, approaches, pens, alleys, tached shall not be removed by anyone etc.; flybreeding material; other other than a Program employee. conditions. All operating and storage rooms and § 308.16 Sanitation requirements for departments of official establishments electrical stimulating (EST) equip- used for inedible materials shall be ment. maintained in acceptably clean condi- (a) Hide-on stimulation. Automatic tion. The outer premises of every offi- and manually operated equipment may cial establishment, including docks be used to apply electrical stimualtion and areas where cars and vehicles are to the hide-on surface of slaughtered loaded, and the driveways, approaches, carcasses provided no opening cuts yards, pens, and alleys, shall be prop- other than the stick wound or foot re- erly paved and drained and kept in moval have been made in the carcass. clean and orderly condition. All catch If the hide is penetrated by electrodes, basins on the premises shall be of such the penetrated tissue shall be trimmed. construction and location and shall be Disinfection of electrodes between each given such attention as will insure hide-on carcass stimulation is not nec- their being kept in acceptable condi- essary. tion as regards odors and cleanliness. (b) Hide-off stimulation. (1) Automatic Catch basins shall not be located in de- or manually operated equipment may partments where any product is pre- be used to apply electrical stimulation pared, handled, or stored. The accumu- to carcasses after complete hide relation on the premises of official estab- moval. Partially skinned carcasses lishments of any material in which shall not be stimulated. flies may breed, such as hog hair, (2) If stimulation is applied before bones, paunch contents, or manure, is the carcass has been inspected, the car- forbidden. No other conditions that cass contact surfaces of the equipment may result in adulteration of product shall be disinfected with a disinfectant or interfere with inspection shall be al- approved by the Administrator 1 before lowed in any official establishment or stimulation of the next carcass. In the on its premises. event that carcass contact surfaces of the equipment cannot be cleaned and § 308.14 Employment of diseased per- disinfected between carcass stimula- sons. tions, those surfaces shall be imme- No operator of an official establish- diately removed from contact with the ment or other person preparing product exposed carcass and cleaned and dis- in an official establishment shall em- infected before carcass contact is re- ploy, in any department where any sumed. product is handled or prepared, any (3) If stimulation is applied after the person showing evidence of a commu- carcass has been inspected, carcass nicable disease in a transmissible contact surfaces of the equipment need stage, or known to be a carrier of such not be disinfected with a disinfectant a disease, or while affected with boils, approved by the Administrator before sores, infected wounds, or other abnor- stimulation of the next carcass. Car- mal sources of microbiological con- cass contact surfaces shall be main- taminants. tained in a clean and sanitary condition. § 308.15 Tagging insanitary equipment, (c) Preventing product contamination. utensils, rooms or compartments. Carcass contamination of edible tissue When, in the opinion of a Program by stomach contents, feces and/or urine employee, any equipment, utensil, room, or compartment at an official es- 1 tablishment is unclean or its use would A list of approved disinfectants is available upon request from the Facilities, Equip- be in violation of any of the regula- ment and Sanitation Division, Technical tions in this subchapter, he will attach Services, Food Safety and Inspection Serv- a ‘‘U.S. Rejected’’ tag thereto. No ice, U.S. Department of Agriculture, Wash- equipment, utensil, room, or compart- ington, DC 20250.

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is unacceptable. To prevent such occur- § 309.1 Ante-mortem inspection in pens rences, any of the following optional of official establishments. procedures may be used before stimula- (a) All livestock offered for slaughter tion to prevent this contamination: in an official establishment shall be ex- (1) Leave the sphincter muscles in- amined and inspected on the day of and tact; before slaughter unless, because of un- (2) Cut the rectum and the urethra usual circumstances, prior arrange- free from surrounding tissue and se- ments acceptable to the Administrator curely tie each off; have been made in specific cases by the (3) Partially open the mid-line and/or circuit supervisor for such examination saw the brisket to reduce pressure on and inspection to be made on a dif- the visceral organs; or ferent day before slaughter. (4) Any other pressure-relieving or (b) Such ante-mortem inspection discharge-restricting alternative ac- shall be made in pens on the premises ceptable to the Administrator. Alter- of the establishment at which the live- natives should be presented in writing, stock are offered for slaughter before through the inspector-in-charge, to the the livestock shall be allowed to enter Program for approval. into any department of the establish- (d) All equipment must be Cleaning. ment where they are to be slaughtered thoroughly cleaned at least daily. or dressed or in which edible products [53 FR 46433, Nov. 17, 1988] are handled. When the holding pens of an official establishment are located in PART 309—ANTE-MORTEM a public stockyard and are reserved for INSPECTION the exclusive use of the establishment, such pens shall be regarded as part of Sec. the premises of that establishment and 309.1 Ante-mortem inspection in pens of of- the operator of the establishment shall ficial establishments. be responsible for compliance with all 309.2 Livestock suspected of being diseased requirements of the regulations in this or affected with certain conditions; iden- subchapter with respect to such pens. tifying suspects; disposition on post- mortem inspection or otherwise. § 309.2 Livestock suspected of being 309.3 Dead, dying, disabled, or diseased and diseased or affected with certain similar livestock. conditions; identifying suspects; 309.4 Livestock showing symptoms of cer- disposition on post-mortem inspec- tain metabolic, toxic, nervous, or cir- tion or otherwise. culatory disturbances, nutritional imbalances, or infectious or parasitic diseases. (a) Any livestock which, on ante- 309.5 Swine; disposal because of hog cholera. mortem inspection, do not clearly 309.6 Epithelioma of the eye. show, but are suspected of being af- 309.7 Livestock affected with anthrax; fected with any disease or condition cleaning and disinfection of infected live- that, under part 311 of this subchapter, stock pens and driveways. may cause condemnation of the carcass 309.8 Cattle affected with anasarca and generalized edema. on post-mortem inspection, and any 309.9 Swine erysipelas. livestock which show, on ante-mortem 309.10 Onset of parturition. inspection, any disease or condition 309.11 Vaccine livestock. that, under part 311 of this subchapter 309.12 Emergency slaughter; inspection would cause condemnation of only part prior to. of the carcass on post-mortem inspec- 309.13 Disposition of condemned livestock. tion, shall be so handled as to retain 309.14 Brucellosis-reactor goats. 309.15 Vesicular diseases. its identity as a suspect until it is 309.16 Livestock suspected of having bio- given final post-mortem inspection, logical residues. when the carcass shall be marked and 309.17 Livestock used for research. disposed of as provided in parts 310 and 309.18 Official marks and devices for pur- 311 of this subchapter, or until it is dis- poses of ante-mortem inspection. posed of as otherwise provided in this AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, part. 2.55. (b) All seriously crippled animals and SOURCE: 35 FR 15563, Oct. 3, 1970, unless animals commonly termed ‘‘downers,’’ otherwise noted. shall be identified as U.S. Suspects and

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disposed of as provided in § 311.1 of this released for any purpose. Otherwise, it subchapter unless they are required to shall be identified as U.S. Suspect and be classed as condemned under § 309.3. disposed of as provided in § 311.5 of this (c) Livestock which have reacted to a subchapter, or condemned and disposed test for leptospirosis, or anaplasmosis, of as provided in § 309.13, whichever is but which show no symptoms of the appropriate. disease, shall be identified as U.S. Sus- (j) Any livestock which is affected pects and disposed of as provided in with vesicular exanthema or vesicular § 311.10 of this subchapter. stomatitis, but which has recovered to (d) Livestock which are known to the extent that the lesions are in proc- have reacted to the tuberculin test ess of healing, the temperature is with- shall be identified as U.S. Suspects and in normal range, and the livestock disposed of as provided in § 311.2 of this shows a return to normal appetite and subchapter, except that livestock bear- activity, shall be identified as U.S. ing an official ‘‘USDA Reactor’’ or Suspect and disposed of as provided in similar State reactor tag shall not be § 311.32 of this subchapter, except that tagged as U.S. Suspects. if desired, such livestock may be set (e) Any cattle found on ante-mortem apart and held under supervision of a inspection to be affected with Program employee or other official epithelioma of the eye or of the orbital designated by the area supervisor for region to a lesser extent than as de- treatment. If the livestock is set aside scribed in § 309.6 shall be identified as a for treatment, the U.S. Suspect identi- U.S. Suspect and disposed of as pro- fication device will be removed by a vided in § 311.12 of this subchapter. Program employee, following such (f) Cattle found on ante-mortem in- treatment, if the livestock is found to spection to be affected with anasarca be free from any such disease. Such to a lesser extent than as described in livestock found to be free from any § 309.8 shall be identified as U.S. Sus- such disease may be released for pects and disposed of as provided in slaughter or for purposes other than § 311.8 of this subchapter or paragraph slaughter, provided that in the latter (g) of this section. instance, the operator of the official (g) Any livestock suspected of being establishment or the owner of the ani- affected with anasarca may be set mal shall first obtain permission from apart and held for treatment under the local, State, or Federal livestock Program or other responsible official sanitary official having jurisdiction supervision approved by the area super- over the movement of such livestock. visor. If at the expiration of the treat- (k) Livestock which are offered for ment period the livestock upon exam- ante-mortem inspection under this ination is found to be free from disease, part, and which are regarded by the in- it may be released for any purpose. spector as immature, shall be identi- Otherwise, it shall be identified as U.S. fied as U.S. Suspects and, if slaugh- Suspect and disposed of as provided in tered, the disposition of their carcasses § 311.8 of this subchapter or condemned shall be determined by the post- and disposed of as provided in § 309.8, mortem findings in connection with whichever is appropriate. the ante-mortem conditions. If not (h) All hogs suspected on ante- slaughtered as suspects, such livestock mortem inspection of being affected shall be held under supervision of a with swine erysipelas shall be identi- Program employee or other official fied as U.S. Suspects and disposed of as designated by the area supervisor, and provided in § 311.5 of this subchapter or after sufficient development may be re- paragraph (i) of this section. leased for slaughter or may be released (i) A hog suspected of being affected for any other purpose, provided they with swine erysipelas may be set apart have not been exposed to any infec- and held for treatment under Program tious or contagious disease. If such ex- or other responsible official super- posure occurs, permission should be ob- vision approved by the area supervisor. tained from the nearest Veterinary If at the expiration of the treatment Services unit of the Animal and Plant period the animal upon examination is Health Inspection Service prior to re- found to be free from disease, it may be lease of such livestock.

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(l) Livestock previously condemned (b) Livestock plainly showing on for listeriosis, if released for slaughter ante-mortem inspection any disease or under § 309.13(b) shall be identified as a condition that, under part 311 of this U.S. Suspect in accordance with subchapter, would cause condemnation § 309.13(c). of their carcasses on post-mortem in- (m) Each animal required by this spection shall be identified as U.S. Con- part to be treated as a U.S. Suspect demned and disposed of in accordance shall be identified as such by or under with § 309.13. the supervision of a Program employee (c) Any swine having a temperature with an official device in accordance of 106 °F. or higher and any cattle, with § 309.18. No such device shall be re- sheep, goats, horses, mules, or other moved except by a Program employee. equines having a temperature of 105 °F. (n) Each animal identified as a U.S. or higher shall be identified as U.S. Suspect on ante-mortem inspection Condemned. In case of doubt as to the shall be set apart and shall be slaugh- cause of the high temperature, or when tered separately from other livestock for other reasons a Program employee at that establishment unless disposed deems such action warranted, any such of as otherwise provided in this part. livestock may be held for a reasonable (o) Each animal identified as a U.S. time under the supervision of a Pro- Suspect on ante-mortem inspection, gram employee for further observation when presented for slaughter shall be and taking of temperature before final accompanied with a form MP 402–2 on disposition of such livestock is deter- which the inspector at the establish- mined. Any livestock so held shall be ment shall record the U.S. Suspect reinspected on the day it is slaugh- identification number and any other tered. If, upon such reinspection, or identifying tag numbers present and a when not held for further observation brief description of the animal and of and taking of temperature, then on the the disease or condition for which the original inspection, the animal has a animal was classed as a suspect, in- temperature of 106 °F. or higher in the cluding its temperature when the tem- case of swine, or 105 °F. or higher in the perature of such animal might have a case of other livestock, it shall be con- bearing on the disposition of the car- demned and disposed of in accordance cass on post-mortem inspection. with § 309.13. (p) When any animal identified as a (d) Any livestock found in a coma- U.S. Suspect is released for any pur- tose or semicomatose condition or af- pose or reason, as provided in this part, fected with any condition not other- the official identification device shall wise covered in this part, which would be removed only by a Program em- preclude release of the animal for ployee and he shall report his action to slaughter for human food, shall be the area supervisor. When a suspect is identified ‘‘U.S. Condemned’’ and dis- to be released under the provisions of posed of in accordance with § 309.13, ex- this part for a purpose other than cept that such animal may be set apart slaughter, the operator of the official and held for further observation or establishment or the owner of the ani- treatment under supervision of a Pro- mal shall first obtain permission for gram employee or other official des- the removal of such animal from the ignated by the area supervisor and for local, State or Federal livestock sani- final disposition in accordance with tary official having jurisdiction. this part. [35 FR 15563, Oct. 3, 1970, as amended at 38 FR § 309.4 Livestock showing symptoms of 29214, Oct. 23, 1973; 39 FR 36000, Oct. 17, 1974] certain metabolic, toxic, nervous, or circulatory disturbances, nutri- § 309.3 Dead, dying, disabled, or dis- tional imbalances, or infectious or eased and similar livestock. parasitic diseases. (a) Livestock found to be dead or in a (a) All livestock showing, on ante- dying condition on the premises of an mortem inspection, symptoms of official establishment shall be identi- anaplasmosis, ketosis, leptospirosis, fied as U.S. Condemned and disposed of listeriosis, parturient paresis, in accordance with § 309.13. pseudorabies, rabies, scrapie, tetanus,

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grass tetany, transport tetany, stran- stroyed or obscured by neoplastic tis- gles, purpura hemorrhagica, azoturia, sue and which shows extensive infec- infectious equine encephalomyelitis, tion, suppuration, and necrosis, usually toxic encephalomyelitis (forage poison- accompanied with foul odor, or any ing), dourine, acute influenza, general- animal affected with epithelioma of ized osteoporosis, glanders (farcy), the eye or of the orbital region which, acute inflammatory lameness or exten- regardless of extent, is accompanied sive fistula shall be identified as U.S. with cachexia shall be identified as Condemned and disposed of in accord- U.S. Condemned and disposed of in ac- ance with § 309.13. cordance with § 309.13. (b) If any equine is suspected on ante- mortem inspection of being infected § 309.7 Livestock affected with an- with glanders or dourine, the nearest thrax; cleaning and disinfection of Veterinary Services unit of the Animal infected livestock pens and driveways. and Plant Health Inspection Service shall be so informed by a Program em- (a) Any livestock found on ante- ployee. Tests shall be performed by mortem inspection to be affected with said unit to determine whether the ani- anthrax shall be identified as U.S. Con- mal is, in fact, infected with such dis- demned and disposed of in accordance ease. If it is found on such tests to be with § 309.13. infected, the animal shall be disposed (b) No other livestock of a lot in of in accordance with paragraph (a) of which anthrax is found on ante- this section. Otherwise, the animal mortem inspection shall be slaughtered shall be identified as a U.S. Suspect and presented for post-mortem inspec- and disposed of as provided in § 311.10 of tion until it has been determined by a this subchapter. careful ante-mortem inspection that no anthrax infected livestock remains in [35 FR 15563, Oct. 3, 1970 as amended at 38 FR the lot. 29214, Oct. 23, 1973] (c) Apparently healthy livestock § 309.5 Swine; disposal because of hog (other than hogs) from a lot in which cholera. anthrax is detected, and any apparently healthy livestock which have (a) All swine found by an inspector to been treated with anthrax biologicals be affected with hog cholera shall be which do not contain living anthrax or- identified as U.S. Condemned and dis- ganisms, may be slaughtered and pre- posed of in accordance with § 309.13. Im- sented for post-mortem inspection if mediate notification shall be given by they have been held not less than 21 the inspector to the official in the Vet- days following the last treatment or erinary Services unit of the Animal the last death of any livestock in the and Plant Health Inspection Service lot. Alternatively, if desired, all appar- who has responsibility for the control ently healthy livestock of the lot may of swine diseases in the State where be segregated and held for treatment the swine are located. by a State licensed veterinarian under (b) All swine, even though not them- supervision of a Program employee or selves identified as U.S. Suspects, other official designated by the area which are of lots in which one or more supervisor. No anthrax vaccine (live or- animals have been condemned or iden- ganisms) shall be used on the premises tified as U.S. Suspect for hog cholera, of an official establishment. shall, as far as possible, be slaughtered separately and apart from all other (d) Livestock which have been in- livestock passed on ante-mortem injected with anthrax vaccines (live or- spection. ganisms) within 6 weeks, and those bearing evidence of reaction to such [40 FR 27225, June 27, 1975] treatment, such as inflammation, tu- mefaction, or edema at the site of the § 309.6 Epithelioma of the eye. injection, shall be condemned on ante- Any animal found on ante-mortem mortem inspection, or such animals inspection to be affected with may be held under supervision of a Pro- epithelioma of the eye and the orbital gram employee or other official des- region in which the eye has been de- ignated by the area supervisor until

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the expiration of the 6-week period and § 309.12 Emergency slaughter; inspec- the disappearance of any evidence of tion prior to. reaction to the treatment. In all cases of emergency slaughter, (e) When livestock are found on ante- except as provided in § 311.27 of this mortem inspection to be affected with subchapter, the animals shall be in- anthrax, all exposed livestock pens and spected immediately before slaughter, driveways of the official establishment whether theretofore inspected or not. shall be cleaned and disinfected by When the necessity for emergency promptly and thoroughly removing and slaughter exists, the establishment burning all straw, litter, and manure. shall notify the inspector in charge so This shall be followed immediately by that such inspection may be made. a thorough disinfection of the exposed § 309.13 Disposition of condemned live- premises by soaking the ground, stock. fences, gates, and all exposed material (a) Except as otherwise provided in with a 5 percent solution of sodium hy- this part, livestock identified as U.S. droxide or commercial lye prepared as Condemned shall be killed by the offi- outlined in § 310.9(e)(1) of this sub- cial establishment, if not already dead. chapter, or other disinfectant that may Such animals shall not be taken into be approved in specific cases by the Ad- the official establishment to be slaugh- ministrator specifically for this pur- tered or dressed; nor shall they be con- pose. veyed into any department of the establishment used for edible products; § 309.8 Cattle affected with anasarca but they shall be disposed of in the and generalized edema. manner provided for condemned car- All cattle found on ante-mortem in- casses in part 314 of this subchapter. spection to be affected with anasarca The official U.S. Condemned tag shall in advanced stages and characterized not be removed from, but shall remain by an extensive and generalized edema on the carcass until it goes into the shall be identified as U.S. Condemned tank, or is otherwise disposed of as pre- and disposed of in accordance with scribed in part 314 of this subchapter, § 309.13. at which time such tag may be removed by a Program employee only. § 309.9 Swine erysipelas. The number of such tag shall be reported to the veterinary medical offi- All hogs plainly showing on ante- cer by the inspector who affixed it, and mortem inspection that they are af- also by the inspector who supervised fected with acute swine erysipelas shall the tanking of the carcass. be identified as U.S. Condemned and (b) Any livestock condemned on ac- disposed of in accordance with § 309.13. count of ketosis, swine erysipelas, vesicular diseases, grass tetany, trans- § 309.10 Onset of parturition. port tetany, parturient paresis, Any livestock showing signs of the anasarca, anaplasmosis, leptospirosis, onset of parturition shall be withheld listeriosis, or inflammatory condition from slaughter until after parturition including pneumonia, enteritis, and and passage of the placenta. Slaughter peritonitis may be set apart and held or other disposition may then be per- for treatment under supervision of a mitted if the animal is otherwise ac- Program employee or official des- ceptable. ignated by the area supervisor. The U.S. Condemned identification tag will § 309.11 Vaccine livestock. be removed by a Program employee following treatment under such super- Vaccine livestock with unhealed le- vision if the animal is found to be free sions of vaccinia, accompanied with from any such disease. fever, which have not been exposed to (c) Livestock previously affected any other infectious or contagious dis- with listeriosis, including those re- ease, are not required to be slaughtered leased for slaughter after treatment and may be released for removal from under paragraph (b) of this section, the premises. shall be identified as U.S. Suspect.

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(d) When livestock under the provi- ante-mortem inspection. To aid in de- sions of this section is to be released termining the amount of residue for a purpose other than slaughter, the present in the tissues, officials of the operator of the official establishment Program may permit the slaughter of or the owner of the livestock shall first any such livestock for the purpose of obtain permission for the movement of collecting tissues for analysis for the such livestock from the local, State, or residue. Such analysis may include the Federal livestock sanitary official hav- use of inplant screening procedures de- ing jurisdiction. signed to detect the presence of antimicrobial residues in any species of § 309.14 Brucellosis-reactor goats. livestock. Goats which have reacted to a test (b) All carcasses and edible organs for brucellosis shall not be slaughtered and other parts thereof, in which are in an official establishment. found any biological residues which render such articles adulterated, shall § 309.15 Vesicular diseases. be marked as ‘‘U.S. Condemned’’ and (a) Immediate notification shall be disposed of in accordance with § 314.1 or given by the inspector to the local, § 314.3 of this chapter. State, and Federal livestock sanitary (c) [Reserved] officials having jurisdiction when any (d) Calves shall not be presented for livestock is found to be affected with a ante-mortem inspection in an official vesicular disease. establishment except under the provi- (b) No livestock under quarantine by sions of this paragraph. State or Federal livestock sanitary of- (1) Definitions. For purposes of this ficials on account of a vesicular disease paragraph, the following definitions will be given ante-mortem inspection. shall apply: If no quarantine is invoked, or if quar- (i) Calf. A calf up to 3 weeks of age or antine is invoked and later removed, up to 150 pounds. upon ante-mortem inspection, any ani- (ii) Certified calf. A calf that the pro- mal found to be affected with vesicular ducer and all other subsequent exanthema or vesicular stomatitis in custodians of the calf certify in writing the acute stages, as evidenced by acute has not been treated with any animal and active lesions or an elevated tem- drug while in his or her custody or has perature, shall be identified as U.S. been treated with one or more drugs in Condemned and disposed of in accord- accordance with FDA approved label ance with § 309.13. directions while in his or her custody and has been withheld from slaughter § 309.16 Livestock suspected of having for the period(s) of time specified by biological residues. those label directions. (a) Except as provided by paragraph (iii) Healthy calf. A calf that an in- (d) of this section, livestock suspected spector determines shows no visual of having been treated with or exposed signs of disease or treatment of disease to any substance that may impart a bi- at ante-mortem inspection. ological residue which would make the (iv) Producer. The owner of the calf at edible tissues unfit for human food or the time of its birth. otherwise adulterated shall be handled (v) Sick calf. A calf that an inspector in compliance with the provisions of on ante-mortem inspection determines this paragraph. They shall be identified has either signs of treatment or signs at official establishments as ‘‘U.S. Con- of disease. demned.’’ These livestock may be held (vi) Veterinary medical officer. An in- under the custody of a Program em- spector of the Program that has ob- ployee, or other official designated by tained a Doctor of Veterinary Medicine the Administrator, until metabolic degree which is recognized by the Pro- processes have reduced the residue suf- gram. ficiently to make the tissues fit for (2) General requirements. (i) The iden- human food and otherwise not adulter- tity of the producer of each calf pre- ated. When the required time has sented for ante-mortem inspection elapsed, the livestock, if returned for shall be made available by the official slaughter, must be re-examined on establishment to the inspection prior

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to the animal being presented for ante- secure identification which displays a mortem inspection. number which shall be recorded on all (ii) The inspector shall segregate the written certifications. calves presented for ante-mortem in- (iii) The inspector shall have seg- spection at the establishment and iden- regated for veterinary medical officer tify each calf as one of the following: examination any certified calf which (a) Certified, (B) noncertified, or (C) he or she determines to show any sign previous residue condemnation. of disease or which is not identified in- (3) Certified group. (i) For a calf to be dividually. Such animal will be tagged considered certified, the producer and as ‘‘U.S. Suspect’’ and its carcass will all other subsequent custodians of the be retained on post-mortem inspection calf must certify in writing that while and handled in accordance with the calf was in his or her custody, the § 310.21(c) and (d). calf was not treated with animal drugs (iv) The inspector shall handle the re- or was treated with one or more drugs maining carcasses of healthy animals in accordance with FDA approved label in accordance with § 310.21(c) and (d). directions and was withheld from slaughter for the period(s) of time spec- (4) Noncertified group. On ante- ified by those label directions. All prior mortem inspection, the inspector shall certifications must be presented with have segregated for veterinary medical the animal at the time of slaughter. officer examination any calf which he The certifications shall contain a list or she determines to show any sign of of the calves with accompanying iden- disease. Such animal will be tagged as tification numbers, as required by ‘‘U.S. Suspect’’ and its carcass will be paragraph (d)(3)(ii) of this section, fol- retained on post-mortem inspection lowed by the following language: and handled in accordance with § 310.21(c). The inspector shall handle I hereby certify that, while in my custody, the remaining carcasses of healthy ani- llll llll from to (time period of cus- mals in accordance with § 310.21(c). tody), the above-listed calf or calves have not been treated with drugs, or have been (5) Calves from producers with previous treated with one or more drugs in accord- residue condemnation. On ante-mortem ance with FDA approved label directions and inspection, the inspector shall have have been withheld from slaughter for the segregated for veterinary medical offi- period(s) of time specified by those label di- cer examination any calf which he or rections. I certify that, to the best of my she determines to show any sign of dis- knowledge and belief, all information con- ease. Such animal will be tagged as tained herein is true, that the information may be relied upon at the official establish- ‘‘U.S. Suspect’’ and its carcass will be ment, and that I understand that any willful retained on post-mortem inspection falsification of this certification is a felony and handled in accordance with and may result in a fine of up to $250,000 for § 310.21(e). The inspector shall handle an individual or up to $500,000 for an organi- the remaining carcasses of healthy ani- zation, or imprisonment for not more than 5 mals in accordance with § 310.21(e). years, or both (21 U.S.C. 677, 18 U.S.C. 1001 (e) The name of each and all person(s) and 3571). who sold or consigned each swine to Executed on ————————————————— the establishment shall be made avail- (date of certification) able by the establishment to any Pro- ———————————————————————— gram employee or other authorized em- (signature of certifier) ployee of the United States Depart- ———————————————————————— ment of Agriculture upon that employ- (typed or printed name and address of cer- ee’s request and presentation of his or tifier) her official credentials. Swine identi- ———————————————————————— fication, by means approved by the (business of certifier) Animal and Plant Health Inspection (ii) Each calf must be identified by Service, USDA, under part 71 of this use of backtag, eartag, or other type of title, must be maintained throughout

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post-mortem inspection, in accordance cordance with the labeling approved with § 310.23(a) of this subchapter. under said regulations; (5) In the case of an animal subjected (Recordkeeping requirements approved by the Office of Management and Budget under to any experimental economic poison control number 0583–0053) under section 2(a) of the Federal Insec- [36 FR 24928, Dec. 24, 1971, as amended at 44 ticide, Fungicide, and Rodenticide Act, FR 45606, Aug. 3, 1979; 44 FR 59499, Oct. 16, as amended (7 U.S.C. 135 et seq.), the 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. product was prepared and distributed 20, 1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, in accordance with § 362.17 of the regu- Dec. 30, 1985; 52 FR 2104, Jan. 20, 1987; 53 FR lations issued under said Act (7 CFR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990] 362.17), and used in accordance with the labeling approved under said regula- § 309.17 Livestock used for research. tions. (a) No livestock used in any research (6) In the case of an animal adminis- investigation involving an experi- tered or subjected to any substance mental biological product, drug, or that is a food additive or pesticide chemical shall be eligible for slaughter chemical under the Federal Food, at an official establishment unless: Drug, and Cosmetic Act, supra, there (1) The operator of such establish- has been compliance with all tolerance ment, the sponsor of the investigation, limitations established by said Act and or the investigator has submitted to the regulations promulgated there- the Program, or the Veterinary Serv- under (21 CFR 1.1 et seq.), and all other ices unit of the Animal and Plant restrictions and requirements imposed Health Inspection Service of the De- by said Act and said regulations will be partment of Agriculture or to the Envi- complied with at the time of slaughter. ronmental Protection Agency or to the (b) The inspector in charge may deny Food and Drug Administration of the or withdraw the approval for slaughter Department of Health, Education, and of any livestock subject to the provi- Welfare, data or a summary evaluation sion of this section when he deems it of the data which demonstrates that necessary to assure that all products the use of such biological product, prepared at the official establishment drug, or chemical will not result in the are free from adulteration. products of such livestock being adulterated, and a Program employee has § 309.18 Official marks and devices for approved such slaughter; purposes of ante-mortem inspec- (2) Written approval by the Deputy tion. Administrator, Meat and Poultry In- (a) All livestock required by this part spection Field Operations is furnished to be identified as U.S. Suspects shall the area supervisor prior to the time of be tagged with a serially numbered slaughter; metal ear tag bearing the term ‘‘U.S. (3) In the case of an animal adminis- Suspect,’’ except as provided in tered any unlicensed, experimental § 309.2(d) and except that cattle affected veterinary biologic product regulated with epithelioma of the eye, under the Virus-Serum Toxin Act (21 antinomycosis, or actinobacillosis to U.S.C. 151 et seq.), the product was pre- such an extent that the lesions would pared and distributed in compliance be readily detected on post-mortem in- with Part 103 of the regulations issued spection, need not be individually under said Act (part 103 of this title), tagged on ante-mortem inspection with and used in accordance with the label- the U.S. Suspect tag, provided that ing approved under said regulations; such cattle are segregated and other- (4) In the case of an animal adminis- wise handled as U.S. Suspects. tered any investigational drug regu- (b) In addition, identification of U.S. lated under the Federal Food, Drug, Suspect swine must include the use of and Cosmetic Act, as amended (21 tattoos specified by the inspector to U.S.C. 301 et seq.), the drug was pre- maintain the identity of the animals pared and distributed in compliance through the dehairing equipment when with the applicable provisions of part such equipment is used. 135 of the regulations issued under said (c) All livestock required by this part Act (21 CFR part 135), and used in ac- to be identified as U.S. Condemned

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shall be tagged with a serially num- § 310.24 [Reserved] bered metal ear tag bearing the term 310.25 Contamination with microorganisms; ‘‘U.S. Condemned.’’ pathogen reduction performance stand- (d) The devices described in para- ards for Salmonella. graphs (a), (b), and (c) of this section AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, shall be the official devices for identi- 2.53. fication of livestock required to be SOURCE: 35 FR 15567, Oct. 3, 1970, unless identified as U.S. Suspect or U.S. Con- otherwise noted. demned as provided in this part. § 310.1 Extent and time of post-mortem inspection; post-mortem inspection PART 310—POST-MORTEM staffing standards. INSPECTION (a) A careful post-mortem examination and inspection shall be made of Sec. 310.1 Extent and time of post-mortem in- the carcasses and parts thereof of all spection; post-mortem inspection staff- livestock slaughtered at official estab- ing standards. lishments. Such inspection and exam- 310.2 Identification of carcass with certain ination shall be made at the time of severed parts thereof and with animal slaughter unless, because of unusual from which derived. circumstances, prior arrangements ac- 310.3 Carcasses and parts in certain in- ceptable to the Administrator have stances to be retained. been made in specific cases by the cir- 310.4 Identification of carcasses and parts; tagging. cuit supervisor for making such inspec- 310.5 Condemned carcasses and parts to be tion and examination at a later time. so marked; tanking; separation. (b)(1) The staffing standards on the 310.6 Carcasses and parts passed for cook- basis of the number of carcasses to be ing; marking. inspected per hour are outlined in the 310.7 Removal of spermatic cords, pizzles following tables. Standards for mul- and preputial diverticuli. tiple inspector lines are based on in- 310.8 Passing and marking of carcasses and spectors rotating through the different parts. 310.9 Anthrax; carcasses not to be evis- types of inspection stations during cerated; disposition of affected carcasses; each shift to equalize the workload. hides, hoofs, horns, hair, viscera and con- The inspector in charge shall have the tents, and fat; handling of blood and authority to require the establishment scalding vat water; general cleanup and to reduce slaughter line speeds where, disinfection. in his judgment, the inspection proce- 310.10 Carcasses with skin or hide on; clean- dure cannot be adequately performed ing before evisceration; removal of lar- at the current line speed because of vae of Hypodermae, external parasites particular deficiencies in carcass prep- and other pathological skin conditions. 310.11 Cleaning of hog carcasses before in- aration and presentation by the plant cising. at the higher speed, or because the 310.12 Sternum to be split; abdominal and health condition of the particular ani- thoracic viscera to be removed. mals indicates a need for more exten- 310.13 Inflating carcasses or parts thereof; sive inspection. transferring caul or other fat. (2) Cattle inspection. For all cattle 310.14 Handling of bruised parts. staffing standards, an ‘‘a’’ in the 310.15 Disposition of thyroid glands and laryngeal muscle tissue. ‘‘Number of Inspectors by Stations’’ 310.16 Disposition of lungs. column means that one inspector per- 310.17 Inspection of mammary glands. forms the entire inspection procedure 310.18 Contamination of carcasses, organs, and a ‘‘b’’ means that one inspector or other parts. performs the head and lower carcass in- 310.19 Inspection of kidneys. spection and a second inspector per- 310.20 Saving of blood from livestock as an forms the viscera and upper carcass inedible product. 1 310.21 Carcasses suspected of containing spection. sulfa and antibiotic residues; sampling frequency; disposition of affected car- 1 The ‘‘Maximum Slaughter Rates’’ figures casses and parts. listed in paragraph (b)(2)(i) of this section for 310.22 [Reserved] one (a) and two (b) inspector kills are over- 310.23 Identification of carcasses and parts stated because the time required to walk of swine. Continued

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(i) Inspection Using the Viscera COWS AND BULLSÐContinued Truck. Number of inspectors by stations STEERS AND HEIFERS Maximum slaughter rates (head per hour) Head Viscera Car- Number of inspectors cass Maximum slaughter rates (head per by stations 56 to 77 ...... 1 1 1 hour) Car- Head Viscera cass 78 to 81 ...... 1 2 1 82 to 134 ...... 2 2 1 1 to 27 ...... a a a 28 to 56 ...... b b b (A) Rules for determining adjusted 57 to 84 ...... 1 1 1 85 to 86 ...... 1 2 1 maximum slaughter rates for single-in- 87 to 143 ...... 2 2 1 spector kills considering walking distance according to the table in this COWS AND BULLS subdivision: Determine the distances the inspector actually walks between Number of inspectors the points shown in columns 2 through by stations Maximum slaughter rates (head per 14 of the following table. For each col- hour) Car- umn, determine the deduction figure Head Viscera cass opposite the appropriate number of feet 1 to 27 ...... a a a in column 1. Compute the total of the 28 to 55 ...... b b b deduction figures for columns 2 through 14. The adjusted maximum from one inspection station to another is not rate is the maximum rate in paragraph included. To determine the proper adjusted (b)(2)(i) of this section minus total of maximum slaughter line speed, paragraph (b)(2)(i)(A) of this section for one inspector the deduction figures. If the resultant kills or paragraph (b)(2)(i)(B) of this section number is not a whole number, it must for two inspector kills must be used along be rounded off to the next lowest whole with their accompanying rules. number.

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(B) Rules for determining adjusted termine the deduction figure opposite maximum slaughter rates for two-in- the appropriate number of feet in col- spector kills considering walking dis- umn 1. Compute the total of the deduc- tance according to the table in this tion figures for columns 2 through 9. subdivision: Determine the distances Divide this total by 2. The adjusted the inspectors actually walk between maximum rate is the maximum rate in the points shown in columns 2 through paragraph (b)(2)(i) of this section 9 of the following table. Column 9 is minus the number calculated above. If used only if the condemned brands and the resultant number is not a whole tags the viscera inspector uses are kept number, it must be rounded off to the at a location other than at the wash- next lowest whole number. basin-sterilizer. For each column, de-

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(ii) Inspection Using Viscera Table, COWS AND BULLS Tongue-In Presentation of Heads. Number of inspectors by stations STEERS AND HEIFERS Maximum slaughter rates (head per hour) Car- Head Viscera cass Number of inspectors by stations Maximum slaughter rates (head per 1 to 29 ...... a a a hour) Car- 30 to 56 ...... b b b Head Viscera cass 57 to 79 ...... 1 1 1 80 to 98 ...... 1 2 1 1 to 32 ...... a a a 99 to 147 ...... 2 2 1 33 to 58 ...... b b b 148 to 174 ...... 2 3 1 175 to 205 ...... 3 3 1 59 to 84 ...... 1 1 1 206 to 233 ...... 3 4 1 85 to 86 ...... 1 2 1 234 to 256 ...... 3 4 2 87 to 143 ...... 2 2 1 257 to 288 ...... 4 4 2 144 to 171 ...... 3 2 1 289 to 316 ...... 5 4 2 172 to 198 ...... 3 3 1 317 to 343 ...... 5 5 2 199 to 226 ...... 3 3 2 227 to 253 ...... 4 3 2 (3) Swine Inspection. The following in- 254 to 280 ...... 4 4 2 spection staffing standards are applica- 281 to 306 ...... 5 4 2 ble to swine slaughter configurations. 307 to 333 ...... 5 5 2 The inspection standards for all slaughter lines are based upon the ob- COWS AND BULLS servation rather than palpation, at the viscera inspection station, of the Number of inspectors spleen, liver, heart, lungs, and medi- Maximum slaughter rates (head per by stations astinal lymph nodes. In addition, for hour) Car- Head Viscera cass one- and two-inspector lines, the standards are based upon the distance 1 to 29 ...... a a a walked (in feet) by the inspector be- 30 to 56 ...... b b b tween work stations; and for three or 57 to 77 ...... 1 1 1 78 to 81 ...... 1 2 1 more inspector slaughter lines, upon 82 to 134 ...... 2 2 1 the use of a mirror, as described in 135 to 159 ...... 2 3 1 § 307.2(m)(6), at the carcass inspection 160 to 187 ...... 3 3 1 station. Although not required in a 188 to 213 ...... 3 4 1 one- or two-inspector slaughter con- 214 to 234 ...... 3 4 2 figuration, except in certain cases as 235 to 264 ...... 4 4 2 265 to 289 ...... 5 4 2 determined by the inspection service, if 290 to 314 ...... 5 5 2 a mirror is used, it must comply with the requirements of § 307.2(m)(6). (iii) Inspection Using Viscera Table, Tongue-Out Presentation of Heads. TABLE 1.ÐONE INSPECTORÐSTAFFING STANDARDS FOR SWINE

STEERS AND HEIFERS Maximum inspection rates (head per hour) Number of inspectors by stations Market hogs Sows and boars Maximum slaughter rates (head per Distance walked 1 in (heads attached (heads de- hour) Car- feet isÐ or detached) tached) Head Viscera cass With- With With- With 1 to 32 ...... a a a out out mirror mirror mirror mirror 33 to 58 ...... b b b 59 to 86 ...... 1 1 1 0 to 5 ...... 140 150 131 143 87 to 103 ...... 1 2 1 6 to 10 ...... 134 144 126 137 104 to 156 ...... 2 2 1 11 to 15 ...... 129 137 122 132 157 to 186 ...... 2 3 1 16 to 20 ...... 124 132 117 127 187 to 216 ...... 3 3 1 21 to 35 ...... 120 127 113 122 26 to 30 ...... 116 122 110 118 217 to 246 ...... 3 3 2 31 to 35 ...... 112 118 106 114 247 to 275 ...... 3 4 2 36 to 40 ...... 108 114 103 110 276 to 304 ...... 4 4 2 41 to 45 ...... 105 110 100 106 305 to 333 ...... 4 5 2 46 to 50 ...... 101 107 97 103 334 to 362 ...... 5 5 2 51 to 55 ...... 98 103 94 100 363 to 390 ...... 5 6 2 56 to 60 ...... 96 100 91 97 61 to 65 ...... 93 97 89 94

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TABLE 1.ÐONE INSPECTORÐSTAFFING TABLE 3.ÐTWO INSPECTORSÐSTAFFING STANDARDS FOR SWINEÐContinued STANDARDS FOR SOWS AND BOARS

Maximum inspection rates (head Maximum inspection rates (head per per hour) hour) Market hogs Sows and boars Line Configuration Distance walked 1 in (heads attached (heads de- Distance walked 1 in feet Car- Viscera,2 Head,2 feet isÐ or detached) tached) Head,2 by inspector B cass,2 head viscera isÐ head car- car- viscera With- With With- With car- out out viscera,3 cass,3 cass,3 mirror mirror cass,3 mirror mirror heads heads heads heads de- de- de- attached 66 to 70 ...... 90 95 87 92 tached tached tached 71 to 75 ...... 88 92 85 89 76 to 80 ...... 86 89 82 87 Without Mirror 81 to 85 ...... 84 87 80 85 86 to 90 ...... 82 85 79 83 0 to 5 ...... 144±248 144±254 144±267 144±267 91 to 95 ...... 80 83 77 81 6 to 10 ...... 144±235 144±240 144±253 144±253 96 to 100 ...... 78 81 75 79 11 to 15 ...... 144±222 144±227 144±239 144±239 16 to 20 ...... 144±211 144±215 144±226 144±226 1 Distance walked is the total distance that the inspector will 21 to 25 ...... 144±201 144±205 144±214 144±214 have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, head, and wash-basin). With Mirror

TABLE 2.ÐTWO INSPECTORSÐSTAFFING 0 to 5 ...... 144±248 144±292 144±305 144±292 STANDARDS FOR MARKET HOGS 6 to 10 ...... 144±235 144±273 144±291 144±280 11 to 15 ...... 144±222 144±256 144±272 144±268 Maximum inspection rates (head 16 to 20 ...... 144±211 144±241 144±255 144±255 per hour with heads attached or 21 to 25 ...... 144±201 144±228 144±240 144±240 detached) Distance walked 1 in feet 1 Distance walked is the total distance that Inspector B will by inspector B isÐ Line configuration have to walk between work stations during one inspection cycle (e.g., between viscera, carcass, and washbasin). Carcass,2 Viscera,2 Head,2 2 Inspector A. head head car- viscera 3 viscera 3 cass 3 carcass 3 Inspector B. NOTE: In multiple-inspector plants, the in- Without Mirror spectors must rotate between all inspection positions during each shift to equalize the 0 to 5 ...... 151±253 151±271 151±296 workload. 6 to 10 ...... 151±239 151±255 151±277 11 to 15 ...... 151±226 151±240 151±260 TABLE 4.ÐTHREE INSPECTORS OR MOREÐ 16 to 20 ...... 151±214 151±227 151±244 TAFFING TANDARDS FOR WINE 21 to 25 ...... 151±204 151±215 151±231 S S S

Maximum inspection Number of inspectors by station With Mirror rates (head per hour Car- with heads attached) Head Viscera cass Total 0 to 5 ...... 151±253 151±303 151±318 6 to 10 ...... 151±239 151±283 151±304 Market hogs: 11 to 15 ...... 151±226 151±265 151±289 319 to 506 ...... 1 1 1 3 16 to 20 ...... 151±214 151±249 151±270 507 to 540 ...... 1 2 1 4 21 to 25 ...... 151±204 151±235 151±254 541 to 859 ...... 2 2 1 5 860 to 1,022 ...... 2 3 1 6 1 Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection 1,023 to 1,106 ...... 3 3 1 7 cycle (e.g., between viscera, carcass, and washbasin). Sows and boars: 2 Inspector A. 306 to 439 ...... 1 1 1 3 3 Inspector B. 306 to 462 1 ...... 1 1 1 3 440 to 475 ...... 2 1 1 4 NOTE: In multiple-inspector plants, the in- 476 to 752 ...... 2 2 1 5 spectors must rotate between all inspection 753 to 895 ...... 3 2 1 6 positions during each shift to equalize the 896 to 964 ...... 3 3 1 7 workload. 1 This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.

NOTE: In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift to equalize the workload. [35 FR 15567, Oct. 3, 1970, as amended at 47 FR 33676, Aug. 4, 1982; 50 FR 19903, May 13, 1985]

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§ 310.2 Identification of carcass with this section if such alternate method certain severed parts thereof and would provide a ready means of identi- with animal from which derived. fying a specific carcass with the cor- (a) The head, tail, tongue, thymus responding devices by a Program in- gland, and all viscera of each slaugh- spector during the post-mortem inspec- tered animal, and all blood and other tion. parts of such animal to be used in the (5) Disposition and use of identifying preparation of meat food products or devices. medical products, shall be handled in (i) The official State-Federal Depart- such a manner as to identify them with ment backtags will be collected by a the rest of the carcass and as being de- Program inspector and used to obtain rived from the particular animal in- traceback information necessary for volved, until the post-mortem exam- proper disposition of the animal or car- ination of the carcass and parts thereof cass and otherwise handled according has been completed. Such handling to instructions issued to the inspec- shall include the retention of ear tags, tors. backtags, implants, and other identify- (ii) The devices described in para- ing devices affixed to the animal, in graph (b)(2) of this section shall be col- such a way to relate them to the car- lected by the Program inspector when cass until the post-mortem examina- required to obtain traceback information has been completed. tion necessary for proper disposition of (b) The official State-Federal Depart- the animal or carcass and for control- ment backtag on any carcass shall: ling the slaughter of reactor animals. (1)(i) Be removed from the hide of the Devices not collected for these pur- animal by an establishment employee poses shall be discarded after the post- and placed in a clear plastic bag. The mortem examination is complete. bag containing the tag shall be affixed (6) Plastic bags used by the establish- to the corresponding carcass. ment for collecting identifying devices (ii) The bag containing the tag shall will be furnished by the Department. be removed from the carcass by an establishment employee and presented [35 FR 15567, Oct. 3, 1970; 36 FR 12004, June 24, with the viscera to the Program in- 1971] spector at the point where such inspec- § 310.3 Carcasses and parts in certain tor conducts the viscera inspection. instances to be retained. (2)(i) Brucellosis and tuberculosis ear tags, herd identification ear tags, sales Each carcass, including all detached tags, ear bangles, and similar identi- organs and other parts, in which any fication devices shall be removed from lesion or other condition is found that the animal’s hide or ear by an estab- might render the meat or any part lishment employee and shall be placed unfit for food purposes, or otherwise in a clear plastic bag and affixed to the adulterated, and which for that reason corresponding carcass. would require a subsequent inspection, (ii) The bag containing the tag shall shall be retained by the Program em- be removed from the carcass by an es- ployee at the time of inspection. The tablishment employee and presented identity of every such retained carcass, with the viscera to the Program in- detached organ, or other part shall be spector at the point where such inspec- maintained until the final inspection tor conducts the viscera inspection. has been completed. Retained carcasses (3) In cases where both types of de- shall not be washed or trimmed unless vices described in paragraphs (b)(1) and authorized by the Program employee. (2) of this section are present on the same animal, both types may be placed § 310.4 Identification of carcasses and in the same plastic bag or in two sepa- parts; tagging. rate bags. Such devices and methods as may be (4) The circuit supervisor may allow approved by the Administrator may be the use of any alternate method pro- used for the temporary identification posed by the operator of an official es- of retained carcasses, organs, and other tablishment for handling the type of parts. In all cases, the identification devices described in paragraph (b)(2) of shall be further established by affixing

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‘‘U.S. Retained’’ tags as soon as prac- ‘‘U.S. Retained’’ tags are attached to ticable and before final inspection. the carcasses, the affected tissues shall These tags shall not be removed except be removed and condemned before the by a Program employee. tags are removed. ‘‘U.S. Retained’’ tags shall be removed only by a Program § 310.5 Condemned carcasses and employee. parts to be so marked; tanking; separation. § 310.9 Anthrax; carcasses not to be Each carcass or part which is found eviscerated; disposition of affected on final inspection to be unsound, carcasses; hides, hoofs, horns, hair, unhealthful, unwholesome, or other- viscera and contents, and fat; han- wise adulterated shall be conspicuously dling of blood and scalding vat marked, on the surface tissues thereof, water; general cleanup and dis- by a Program employee at the time of infection. inspection, as ‘‘U.S. Inspected and Con- (a) Carcasses found before eviscera- demned.’’ Condemned detached organs tion to be affected with anthrax shall and other parts of such character that not be eviscerated but shall be re- they cannot be so marked shall be tained, condemned, and immediately placed immediately in trucks or recep- tanked or otherwise disposed of as pro- tacles which shall be kept plainly vided in part 314 of this subchapter. marked ‘‘U.S. Condemned,’’ in letters (b) All carcasses and all parts, includ- not less than 2 inches high. All con- ing hides, hoofs, horns, hair, viscera demned carcasses and parts shall remain in the custody of a Program em- and contents, blood, and fat of any ployee and shall be disposed of as re- livestock found to be affected with an- quired in the regulations in part 314 of thrax shall be condemned and imme- this subchapter at or before the close diately disposed of as provided in part of the day on which they are con- 314 of this subchapter, except that the demned. blood may be handled through the usual blood cooking and drying equip- § 310.6 Carcasses and parts passed for ment. cooking; marking. (c) Any part of any carcass that is Carcasses and parts passed for cook- contaminated with anthrax-infected ing shall be marked conspicuously on material through contact with soiled the surface tissues thereof by a Pro- instruments or otherwise shall be im- gram employee at the time of inspec- mediately condemned and disposed of tion, ‘‘U.S. Passed for Cooking.’’ All as provided in part 314 of this sub- such carcasses and parts shall be chapter. cooked in accordance with part 315 of (d) The scalding vat water through this subchapter, and until so cooked which hog carcasses affected with an- shall remain in the custody of a Pro- thrax have passed shall be immediately gram employee. drained into the sewer and all parts of § 310.7 Removal of spermatic cords, the scalding vat shall be cleaned and pizzles and preputial diverticuli. disinfected as provided in paragraph (e) of this section. Spermatic cords and pizzles shall be removed from all carcasses. Preputial (e)(1) That portion of the slaughter- diverticuli shall be removed from hog ing department, including the bleeding carcasses. area, scalding vat, gambrelling bench, floors, walls, posts, platforms, saws, § 310.8 Passing and marking of car- cleavers, knives, and hooks, as well as casses and parts. employees’ boots and aprons, contami- Carcasses and parts found to be nated through contact with anthrax-in- sound, healthful, wholesome, and oth- fected material, shall, except as pro- erwise not adulterated shall be passed vided in paragraph (e)(2) of this section and marked as provided in part 316 of be cleaned immediately and disinfected this subchapter. In all cases where car- with one of the following disinfectants casses showing localized lesions are passed for food or for cooking and

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or other disinfectant 1 approved specifi- (3) The first and indispensable pre- cally for this purpose by the Adminis- cautionary step for persons who have trator: handled anthrax material is thorough (i) A 5 percent solution of sodium hy- cleansing of the hands and arms with droxide or commercial lye containing liquid soap and running hot water. It is at least 94 percent of sodium hydrox- important that this step be taken im- ide. The solution shall be freshly pre- mediately after exposure, before vege- pared immediately before use by dis- tative anthrax organisms have had solving 21⁄2 pounds of sodium hydroxide time to form spores. In the cleansing, a or lye in 51⁄2 gallons of hot water and brush or other appropriate appliance shall be applied as near scalding hot as shall be used to insure the removal of possible to be most effective. (Owing to all contaminating material from under the extremely caustic nature of sodium and about the fingernails. This process hydroxide solution, precautionary of cleansing is most effective when per- measures such as the wearing of rubber formed in repeated cycles of lathering gloves and boots to protect the hands and rinsing rather than in spending the and feet, and goggles to protect the same amount of time in scrubbing with eyes, should be taken by those engaged a single lathering. After the hands in the disinfection process. It is also have been cleansed thoroughly and advisable to have an acid solution, rinsed free of soap, they may, if de- such as vinegar, in readiness in case sired, be immersed for about 1 minute any of the sodium hydroxide solution in a 1:1,000 solution of bichloride of should come in contact with any part mercury, followed by thorough rinsing of the body.) in clean running water. Supplies of bi- (ii) A solution of sodium hypochlorite chloride of mercury for the purpose containing approximately one-half of 1 must be held in the custody of the vet- percent (5,000 parts per million) of erinary medical officer. (As a pre- available chlorine. The solution shall cautionary measure, all persons ex- be freshly prepared. posed to anthrax infection should re- (iii) When a disinfectant solution has port promptly any suspicious condition been applied to equipment which will (sore or carbuncle) or symptom to a afterwards contact product, the equip- physician, in order that anti-anthrax ment shall be rinsed with clean water serum or other treatment may be ad- before such contact. ministered as indicated.) (2) In case anthrax infection is found in the hog slaughtering department, an [35 FR 15567, Oct. 3, 1970; 36 FR 11903, June 23, immediate preliminary disinfection 1971] shall be made from the head-dropper’s station to the point where the disease § 310.10 Carcasses with skin or hide on; cleaning before evisceration; re- is detected and the affected carcasses moval of larvae of Hypodermae, ex- shall be cut down from the rail and re- ternal parasites and other patholog- moved from the room. Upon comple- ical skin conditions. tion of the slaughtering of the lot of When a carcass is to be dressed with hogs of which the anthrax-infected ani- the skin or hide left on, the skin or mals were a part, slaughtering oper- hide shall be thoroughly washed and ations shall cease, and a thorough cleanup and disinfection shall be made, cleaned before any incision is made for as provided in paragraph (e)(1) of this the purpose of removing any part section. If the slaughter of the lot has thereof or evisceration, except that not been completed by the close of the where calves are slaughtered by the ko- day on which anthrax was detected, the sher method, the heads shall be re- cleanup and disinfection shall not be moved from the carcasses, before wash- deferred beyond the close of that day. ing of the carcasses. The skin shall be removed at the time of post-mortem inspection from any calf carcass in- 1 A list of disinfectants approved for this fested with the larvae of the purpose is available upon request to the Sci- entific Services, Meat and Poultry Inspec- ‘‘oxwarble’’ fly (Hypoderma lineata and tion, Food Safety and Inspection Service, Hypoderma bovis), or external para- U.S. Department of Agriculture, Washing- sites, or affected with other patholog- ton, DC 20250. ical skin conditions.

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§ 310.11 Cleaning of hog carcasses be- facts, a hearing, under applicable rules fore incising. of practice, will be held to resolve the All hair, scurf, dirt, hoofs and claws conflict. shall be removed from hog carcasses, (iii) Final approval of an acceptable and the carcasses shall be thoroughly new proposed method shall be effec- washed and cleaned before any incision tuated by modifying, through rule- is made for inspection or evisceration. making procedures, the Federal regulations to include the new method. § 310.12 Sternum to be split; abdomi- (iv) Uses for which approval is grant- nal and thoracic viscera to be reed are: moved. (A) Compressed air injection of cattle The sternum of each carcass shall be feet to facilitate removal of hair from split and the abdominal and thoracic feet intended for human consumption; viscera shall be removed at the time of (B) Compressed air injection under slaughter in order to allow proper in- the skin of cattle heads to facilitate spection. head skinning; (C) Compressed air injection into the § 310.13 Inflating carcasses or parts skull in conjunction with a captive thereof; transferring caul or other bolt stunner to hold the animal still fat. for dressing operations; or (a)(1) Establishments shall not in- (D) Compressed air injected into the flate carcasses or parts of carcasses abdominal cavity of swine to facilitate with air, except as set forth in para- the skinning operation and to mini- graph (a)(2) of this section. mize the loss of body fat. (2)(i) Any establishment slaughtering The method of compressed air injection livestock that wishes to inflate car- shall be a sanitary procedure that in- casses or parts thereof with air, using cludes air filtration and injection nee- procedures other than the approved dle disinfection. Air filtration shall methods listed below, shall submit a consist of not less than two stages. An request for approval for experimental initial stage of filtration shall occur at testing to the Administrator. Such a or near the use point and shall consist request shall include the purpose of the of an aerosol or coalescing filter, capa- use of air, a detailed description of the ble of filtration to not more than 0.75 procedure for injecting the air and evi- micron, for the removal of oil and dence that the procedure can be per- water. A subsequent stage of filtration formed in a sanitary manner. shall occur at or near the point of nee- (ii) The Administrator shall evaluate dle hose attachment to the air line and newly submitted procedures for the use shall be a particulate filter, capable of of air. If the Administrator determines filtration to not more than 0.3 micron. that any such procedure will likely re- The filters shall be maintained by in- sult in wholesome, unadulterated meat specting regularly to assure they are product, then the Administrator shall working properly, and cleaned or re- approve experimental testing of the placed when necessary. The injection new procedure. In any situation where needle shall be disinfected by place- the Administrator finds a submitted ment in water that is not less than 180 ° procedure to be unlikely to result in F. for at least 10 seconds immediately wholesome, unadulterated meat prod- prior to each injection. uct, the Administrator shall send writ- (b) Transferring the caul or other fat ten notification to the establishment from a fat to a lean carcass is prohib- of the denial of such approval. The es- ited. tablishment may re-submit for evalua- (Approved by the Office of Management and tion a testing procedure that has been Budget under control number 0583–0015) denied, provided that modifications [54 FR 36756, Sept. 5, 1989, as amended at 55 have been made to address the original FR 29565, July 20, 1990] reason for denial. The establishment also shall be afforded an opportunity to § 310.14 Handling of bruised parts. submit a written statement in response When only a portion of a carcass is to to the notification of denial. In those be condemned on account of slight instances where there is a conflict of bruises, either the bruised portion shall

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be removed immediately and disposed posed of at the official establishment, of in accordance with part 314 of this in accordance with §§ 314.1 and 314.3 of subchapter, or the carcass shall be this subchapter. promptly placed in a retaining room and kept until chilled and the bruised [36 FR 11639, June 17, 1971] portion shall then be removed and dis- § 310.17 Inspection of mammary posed of as provided in part 314 of this glands. subchapter. (a) Lactating mammary glands and § 310.15 Disposition of thyroid glands diseased mammary glands of cattle, and laryngeal muscle tissue. sheep, swine, and goats shall be re- (a) Livestock thyroid glands and la- moved without opening the milk ducts ryngeal muscle tissue shall not be used or sinuses. If pus or other objectionable for human food. material is permitted to come in con- (b) Livestock thyroid glands and la- tact with the carcass, the parts of the ryngeal muscle tissue may be distrib- carcass thus contaminated shall be re- uted to pharmaceutical manufacturers moved and condemned. for pharmaceutical use in accordance (b) Nonlactating cow udders may be with § 314.9 or § 325.19(c) of this sub- saved for food purposes provided suit- chapter, if they are labeled in accord- able facilities for handling and inspect- ance with § 316.13(f) of this subchapter. ing them are provided. Examination of Otherwise, they shall be disposed of at udders by palpation shall be done by a the official establishment in accord- Program employee. When necessary, in ance with § 314.1 or § 314.3 of this sub- the judgment of the Program employee chapter. for adequate inspection, the official establishment employees shall incise [53 FR 45890, Nov. 15, 1988] udders in sections no greater than 2 § 310.16 Disposition of lungs. inches in thickness. All udders showing disease lesions shall be condemned by a (a) Livestock lungs shall not be saved Program employee. Each udder shall be for use as human food. properly identified with its respective (b) Lungs found to be affected with disease or pathology and lungs found to carcass and kept separate and apart be adulterated with chemical or bio- from other udders until its disposal has logical residue shall be condemned and been accomplished in accordance with identified as ‘‘U.S. Inspected and Con- the provisions of part 311 of this sub- demned.’’ Condemned lungs may not be chapter. saved for pet food or other nonhuman (c) Lactating mammary glands of food purposes. They shall be main- cattle, sheep, swine, and goats shall tained under inspectional control and not be saved for edible purposes. disposed of in accordance with §§ 314.1 (d) The udders from cows officially and 314.3 of this subchapter. designated as ‘‘Brucellosis reactors’’ or (c) Lungs not condemned under para- as ‘‘Mastitis elimination cows’’ shall be graph (b) of this section may be used in condemned. the preparation of pet food or for other nonhuman food purposes at the official § 310.18 Contamination of carcasses, establishment, provided they are han- organs, or other parts. dled in the manner prescribed in § 318.12 (a) Carcasses, organs, and other parts of this subchapter, or they may be dis- shall be handled in a sanitary manner tributed from the establishment in to prevent contamination with fecal commerce, or otherwise, in accordance material, urine, bile, hair, dirt, or for- with the conditions prescribed in § 325.8 eign matter; however, if contamination of this subchapter for nonhuman food occurs, it shall be promptly removed in purposes or they may be so distributed a manner satisfactory to the inspector. to pharmaceutical manufacturers for (b) Brains, cheek meat, and head pharmaceutical use in accordance with trimmings from animals stunned by §§ 314.9 and 325.19(b) of this subchapter, lead, sponge iron, or frangible bullets if they are labeled as ‘‘Inedible [SPE- shall not be saved for use as human CIES] Lungs—for Pharmaceutical Use food but shall be handled as described Only.’’ Otherwise, they shall be dis- in § 314.1 or § 314.3 of this subchapter.

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§ 310.19 Inspection of kidneys. disease treatment or lesions of disease An employee of the establishment or was from an animal identified as shall open the kidney capsule and ex- sick on ante-mortem. pose the kidneys of all livestock at the (6) Sign of treatment. Sign of treat- time of slaughter for the purpose of ex- ment of a disease is indicated by leak- amination by a Program employee. age around jugular veins, subcutaneous, intramuscular or intraperitoneal § 310.20 Saving of blood from livestock injection lesions, or discoloration from as an edible product. particles or oral treatment in any part Blood may be saved for edible pur- of the digestive tract. poses at official establishments pro- (7) Veterinary medical officer. An in- vided it is derived from livestock, the spector of the Program that has ob- carcasses of which are inspected and tained a Doctor of Veterinary Medicine passed, and the blood is collected, degree which is recognized by the Pro- defibrinated, and handled in a manner gram. so as not to render it adulterated under (c) Selection of carcasses for testing. the Federal Meat Inspection Act and The inspector shall perform a swab bio- regulations issued pursuant thereto. assay test 1 on: The defibrination of blood intended for (1) Any carcass from a calf tagged as human food purposes shall not be done ‘‘U.S. Suspect’’ at the time of ante- with the hands. Anticoagulants speci- mortem inspection, except that calves fied in § 318.7(c)(4) of this subchapter whose carcasses are condemned for pa- may be used in lieu of defibrination. thology shall not be tested for drug residues. [39 FR 1973, Jan. 16, 1974] (2) Any carcass which he/she finds § 310.21 Carcasses suspected of con- has either lesions of disease which is taining sulfa and antibiotic resi- not condemned because of these lesions dues; sampling frequency; disposi- or a sign of treatment of disease at the tion of affected carcasses and parts. time of post-mortem inspection, (a) Calf carcasses from animals sus- (3) Any carcass of a calf from a pro- pected of containing biological residues ducer whose calf or calves have pre- under § 309.16(d) of this subchapter viously been condemned for residues as shall, on post-mortem inspection, be prescribed in paragraph (e) of this sec- handled in accordance with the provi- tion, and sions of this section. (4) Carcasses from healthy-appearing (b) For purposes of this section, the certified and noncertified calves, as de- following definitions shall apply: termined by the veterinary medical of- (1) Calf. A calf up to 3 weeks of age or ficer during ante-mortem inspection, up to 150 pounds. will be selected for testing as set forth (2) Certified calf. A calf that the pro- below: ducer and all other subsequent Sampling Rate (percent custodians of the calf certify in writing of estimated day's has not been treated with any animal Testing level slaughter) drug while in his or her custody or has Noncer- been treated with one or more drugs in Certified tified accordance with FDA approved label A ...... 100 100 directions while in his or her custody B ...... 50 50 and has been withheld from slaughter C ...... 20 30 for the period(s) of time specified by (Start) D ...... 5 10 those label directions. E ...... 2 5 (3) Healthy carcass. A carcass that an inspector determines shows no lesions 1 The procedures for performing the swab of disease or signs of disease treatment bioassay test are set forth in one of two self– at post-mortem inspection instructional guides: ‘‘Performing the (4) Producer. The owner of the calf at CAST’’ or ‘‘Fast Antimicrobial Screen Test.’’ These guides are available for review in the the time of its birth. office of the FSIS Docket Clerk, Room 4352 (5) Sick calf carcass. A calf carcass South, Food Safety and Inspection Service, that an inspector on post-mortem in- U.S. Department of Agriculture, Washing- spection determines has either signs of ton, DC 20250.

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Sampling Rate (percent (8) The veterinary medical officer of estimated day's slaughter) may reduce inspection line rates when, Testing level in his/her judgment, the prescribed Noncer- Certified tified testing cannot be adequately performed within the time available be- F ...... 1 2 cause the establishment’s compliance history dictates a need for extensive (d) Testing of carcasses: testing. (1) The inspector shall test all car- (e) Calves from producers with a pre- casses as prescribed in paragraph (c) of vious residue condemnation. The inspec- this section. tor shall perform a swab bioassay test (2) Upon initiation of this program at on all carcasses of all calves in the an establishment, the inspector shall group. The veterinary medical officer begin the testing rate for carcasses shall determine the test results and from healthy-appearing certified and noncertified calves at Level D as pre- shall condemn any carcass and parts scribed in paragraph (c)(4) of this sec- thereof for which there is a positive tion. The inspector shall increase the test result and pass for human con- testing rate to the next higher level sumption any such carcass and parts the following business day when three thereof for which there is a negative carcasses in 100 or less consecutively test result. All subsequent calves from tested show a positive test result for a the same producer which has pre- drug residue. The inspector shall de- viously sold or delivered to official es- crease it to the next lower level when tablishments any carcass that was con- no more than two calves show a posi- demned because of drug residues must tive test result for a drug residue in ei- be tested according to this paragraph ther 500 calves consecutively tested or until five consecutive animals test all calves tested over a 60 working day completely free of animal drug resi- period. dues. (3) Test results shall be determined (f) If the owner or operator of an offi- by the veterinary medical officer. cial establishment disagrees with the (4) The establishment may designate veterinary medical officer’s disposition one or more of its employees to aid the of carcasses and parts thereof, the inspector in performing the swab bio- owner or operator may appeal as pro- assay test under the supervision of the vided in section 306.5 of this chapter. veterinary medical officer who shall in- terpret the results, maintain animal [50 FR 32164, Aug. 9, 1985, as amended at 52 FR 2104, Jan. 20, 1987; 55 FR 7475, Mar. 2, 1990; identification with the test unit, and 60 FR 66483, Dec. 22, 1995] ensure integrity of the testing program. § 310.22 [Reserved] (5) All carcasses and parts thereof from calves selected for testing shall § 310.23 Identification of carcasses and be retained until all test results are parts of swine. complete. (a) The identification of the car- (6) The veterinary medical officer casses and parts of swine identified in shall condemn all carcasses and parts accordance with part 71 of this title thereof for which there are positive shall be made available to the inspec- test results and release for human con- tor upon the inspector’s request sumption all carcasses and parts there- throughout post-mortem inspection. of for which there are negative test re- (b) If the establishment fails to pro- sults. vide required swine identification, the (7) If there is a positive test result, inspector shall order the retention of subsequent calves from the producer of swine caracasses at the establishment the calf shall be tested in accordance until the completion of tests to con- with paragraph (e) of this section. firm that the carcasses are not adulter- These test results will not be included ated. in computations to determine an establishment’s compliance record. [53 FR 40387, Oct. 14, 1988]

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§ 310.24 [Reserved] stitute an alternative frequency for the frequency of sampling required under § 310.25 Contamination with micro- paragraph (a)(2)(iii) of this section if, organisms; pathogen reduction per- (A) The alternative is an integral formance standards for Salmonella. part of the establishment’s verification (a) Criteria for verifying process con- procedures for its HACCP plan and, trol; E. coli testing. (B) FSIS does not determine, and no- (1) Each official establishment that tify the establishment in writing, that slaughters cattle and/or hogs shall test the alternative frequency is inadequate for Escherichia coli Biotype I (E. coli) to verify the effectiveness of the estab- and shall: lishment’s processing controls. (i) Collect samples in accordance (v) Sampling in very low volume estab- with the sampling techniques, meth- lishments. odology, and frequency requirements in (A) An establishment annually paragraph (a)(2) of this section; slaughtering no more than 6,000 bo- (ii) Obtain analytic results in accord- vines, 20,000 swine, or a combination of ance with paragraph (a)(3) of this sec- bovines and swine not exceeding 6,000 tion; and bovines and 20,000 animals total, shall (iii) Maintain records of such ana- collect one sample per week starting lytic results in accordance with para- the first full week of June and continu- graph (a)(4) of this section. ing through August of each year. An (2) Sampling requirements. establishment slaughtering both spe- (i) Written procedures. Each establish- cies shall collect samples from the spe- ment shall prepare written specimen cies it slaughters in larger numbers. collection procedures which shall iden- Weekly samples shall be collected and tify employees designated to collect tested until the establishment has samples, and shall address location(s) completed and recorded one series of 13 of sampling, how sampling randomness tests that meets the criteria shown in is achieved, and handling of the sample Table 1 of paragraph (a)(5) of this sec- to ensure sample integrity. The writ- tion. ten procedure shall be made available (B) Upon the establishment’s meeting to FSIS upon request. requirements of paragraph (a)(2)(v)(A) (ii) Sample collection. The establish- of this section, weekly sampling and ment shall collect random samples testing is optional, unless changes are from carcasses in the cooler. Samples made in establishment facilities, equip- shall be collected by sponging three ment, personnel or procedures that sites on the selected carcass. On cattle may affect the adequacy of existing carcasses, establishments shall take process control measures, as deter- samples from the flank, brisket, and mined by the establishment or FSIS. rump; on swine carcasses, establish- FSIS determinations that changes ments shall take samples from the have been made requiring resumption ham, belly, and jowl areas. 1 of weekly testing shall be provided to (iii) Sampling frequency. Samples the establishment in writing. shall be taken at a frequency propor- (3) Analysis of samples. Laboratories tional to a slaughter establishment’s may use any quantitative method for volume of production, at the following analysis of E. coli that is approved by rates: the Association of Official Analytic Chemists International 2 or approved Bovines: 1 test per 300 carcasses by a scientific body in collaborative Swine: 1 test per 1,000 carcasses trials against the three tube Most (iv) Sampling frequency alternatives. Probable Number (MPN) method and An establishment operating under a validated HACCP plan in accordance 2 A copy of the ‘‘Official Methods of Analy- with § 417.2(b) of this chapter may sub- sis of the Association of Official Analytical Chemists International,’’ 16th edition, 1995, 1 A copy of FSIS’s ‘‘Guidelines for E. coli is on file with the Director, Office of the Fed- Testing for Process Control verification in eral Register, and may be purchased from Cattle and Swine Slaughter Establishments’’ the Association of Official Analytical Chem- is available for inspection in the FSIS Dock- ists International, Inc., 481 North Frederick et Room. Ave., Suite 500, Gaithersburg, MD 20877–2417.

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agreeing with the 95 percent upper and Records shall be retained at the estab- lower confidence limit of the appro- lishment for a period of 12 months and priate MPN index. shall be made available to FSIS upon (4) Recording of test results. The estab- request. lishment shall maintain accurate (5) Criteria for Evaluation of test re- records of all test results, in terms of sults. An establishment is operating 2 cfu/cm of surface area sponged. Re- within the criteria when the most results shall be recorded onto a process cent E. coli test result does not exceed control chart or table showing at least the upper limit (M), and the number of the most recent 13 test results, by class samples, if any, testing positive at lev- of livestock slaughtered, permitting evaluation of the laboratory results in els above (m) is three or fewer out of accordance with the criteria set forth the most recent 13 samples (n) taken, in paragraph (a)(5) of this section. as follows:

TABLE 1.ÐEVALUATION OF E. COLI TEST RESULTS

Maximum Number of number per- Slaughter class Lower limit of marginal range Upper limit of marginal range samples mitted in tested marginal range

(m) (M) (n) (c)

Steers/heifers ...... Negative a ...... 100 cfu/cm2 ...... 13 3 Cows/bulls ...... Negative a ...... 100 cfu/cm2 ...... 13 3 Market hogs ...... 10 cfu/cm2 ...... 10,000 cfu/cm2 ...... 13 3 a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of at least 5 cfu/cm2 carcass surface area.

(6) Failure to meet criteria. Test results visions of paragraphs (a) (1)–(4) of this that do not meet the criteria described section have not been complied with in paragraph (a)(5) of this section are and written notice of same has been an indication that the establishment provided to the establishment. may not be maintaining process con- (b) Pathogen reduction performance trols sufficient to prevent fecal con- standard; Salmonella. tamination. FSIS shall take further ac- (1) Raw meat product performance tion as appropriate to ensure that all standards for Salmonella. An establish- applicable provisions of the law are ment’s raw meat products, when sam- being met. pled and tested by FSIS for Salmonella, (7) Failure to test and record. Inspec- as set forth in this section, may not tion shall be suspended in accordance test positive for Salmonella at a rate ex- with rules of practice that will be ceeding the applicable national patho- adopted for such proceedings upon a gen reduction performance standard, as finding by FSIS that one or more pro- provided in Table 2:

TABLE 2.ÐSALMONELLA PERFORMANCE STANDARDS

Perform- Maximum ance Stand- Number of number of ard (percent samples positives to Class of product positive for tested achieve Sal- (n) Standard monella)a (c)

Steers/heifers ...... 1.0% 82 1 Cows/bulls ...... 2.7% 58 2 Ground beef ...... 7.5% 53 5 Hogs ...... 8.7% 55 6 Fresh pork sausages ...... bN.A. N.A. N.A.

a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw product based on data developed by FSIS in its nationwide microbiological data collection programs and surveys. Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room. b Not available; values for fresh pork sausage will be added upon completion data collection programs for those products.

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(2) Enforcement. FSIS will sample and PART 311—DISPOSAL OF DISEASED test raw meat products in an individual OR OTHERWISE ADULTERATED establishment on an unannounced basis CARCASSES AND PARTS to determine prevalence of Salmonella in such products to determine compli- Sec. ance with the standard. The frequency 311.1 Disposal of diseased or otherwise adul- and timing of such testing will be terated carcasses and parts; general. based on the establishment’s previous 311.2 Tuberculosis. test results and other information con- 311.3 Hog cholera. cerning the establishment’s perform- 311.5 Swine erysipelas. ance. In an establishment producing 311.6 Diamond-skin disease. 311.7 Arthritis. more than one class of product subject 311.8 Cattle carcasses affected with to the pathogen reduction standard, anasarca or generalized edema. FSIS may sample any or all such class- 311.9 Actinomycosis and actinobacillosis. es of products.3 311.10 Anaplasmosis, anthrax, babesiosis, (3) Noncompliance and establishment bacillary hemoglobinuria in cattle, response. When FSIS determines that blackleg, bluetongue, hemorrhagic septicemia, icterohematuria in sheep, infec- an establishment has not met the per- tious bovine rhinotracheitis, leptospiro- formance standard: sis, malignant epizootic catarrh, stran- (i) The establishment shall take im- gles, purpura hemorrhagica, azoturia, in- mediate action to meet the standard. fectious equine encephalomyelitis, toxic (ii) If the establishment fails to meet encephalomyelitis (forage poisoning), infectious anemia (swamp fever), dourine, the standard on the next series of com- acute influenza, generalized osteoporosis, pliance tests for that product, the es- glanders (farcy), acute inflammatory tablishment shall reassess its HACCP lameness, extensive fistula, and unhealed plan for that product and take appro- vaccine lesions. priate corrective actions. 311.11 Neoplasms. (iii) Failure by the establishment to 311.12 Epithelioma of the eye. 311.13 Pigmentary conditions; melanosis, act in accordance with paragraph xanthosis, ochronosis, etc. (b)(3)(ii) of this section, or failure to 311.14 Abrasions, bruises, abscesses, pus, meet the standard on the third con- etc. secutive series of FSIS-conducted tests 311.15 Brucellosis. for that product, constitutes failure to 311.16 Carcasses so infected that consump- maintain sanitary conditions and fail- tion of the meat may cause food poisoning. ure to maintain an adequate HACCP 311.17 Necrobacillosis, pyemia, and septice- plan, in accordance with part 417 of mia. this chapter, for that product, and will 311.18 Caseous lymphadenitis. cause FSIS to suspend inspection serv- 311.19 Icterus. ices. Such suspension will remain in ef- 311.20 Sexual odor of swine. fect until the establishment submits to 311.21 Mange or scab. the FSIS Administrator or his/her des- 311.22 Hogs affected with urticaria, tinea tonsurans, demodex follicurlorum, or er- ignee satisfactory written assurances ythema. detailing the action taken to correct 311.23 Tapeworm cysts (cysticercus bovis) in the HACCP system and, as appropriate, cattle. other measures taken by the establish- 311.24 Hogs affected with tapeworm cysts. ment to reduce the prevalence of 311.25 Parasites not transmissible to man; pathogens. tapeworm cysts in sheep; hydatid cysts; flukes; gid bladder-worms. [61 FR 38864, July 25, 1996] 311.26 Emaciation. 311.27 Injured animals slaughtered at unusual hours. 311.28 Carcasses of young calves, pigs, kids, lambs, and foals. 3 A copy of FSIS’s ‘‘Sample Collection 311.29 Unborn and stillborn animals. Guidelines and Procedure for Isolation and 311.30 Livestock suffocated and hogs scalded Identification of Salmonella from Meat and alive. Poultry Products’’ is available for inspection in the FSIS Docket Room.

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311.31 Livers affected with carotenosis; liv- the disposition of all carcasses or parts ers designated as ‘‘telangiectatic,’’ ‘‘saw- of carcasses under this part in a man- dust,’’ or ‘‘spotted.’’ ner which will insure that only whole- 311.32 Vesicular diseases. some, unadulterated product is passed 311.33 Listeriosis. 311.34 Anemia. for human food. 311.35 Muscular inflammation, degenera- (b) In cases of doubt as to a condition, or infiltration. tion, a disease, or the cause of a condi- 311.36 Coccidioidal granuloma. tion, or to confirm a diagnosis, rep- 311.37 Odors, foreign and urine. resentative specimens of the affected 311.38 Meat and meat byproducts from live- tissues, properly prepared and stock which have been exposed to radi- packaged, shall be sent for examina- ation. tion to one of the laboratories of the 311.39 Biological residues. Biological Control Section of the Pro- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, gram. 2.55. § 311.2 Tuberculosis. SOURCE: 35 FR 15569, Oct. 3, 1970, unless otherwise noted. The following principles shall apply to the disposition of carcasses of live- § 311.1 Disposal of diseased or other- stock based on the difference in the wise adulterated carcasses and pathogenesis of tuberculosis in swine, parts; general. cattle, sheep, goats, and equines. (a) The carcasses or parts of car- (a) Carcasses condemned. The entire casses of all animals slaughtered at an carcass of swine, cattle, sheep, goats, official establishment and found at the and equines shall be condemned if any time of slaughter or at any subsequent of the following conditions occur: inspection to be affected with any of (1) When the lesions of tuberculosis the diseases or conditions named in are generalized (tuberculosis is consid- this part shall be disposed of according ered to be generalized when the lesions to the section pertaining to the disease are distributed in a manner made pos- or condition: Provided, That no product sible only by entry of the bacilli into shall be passed for human food under the systemic circulation); any such section unless it is found to (2) When on ante mortem inspection be otherwise not adulterated. Products the animal is observed to have a fever passed for cooking or refrigeration found to be associated with an active under this part must be so handled at tuberculosis lesion on post mortem in- the official establishment where they spection; are initially prepared unless they are (3) When there is an associated moved to another official establish- cachexia; ment for such handling or in the case (4) When a tuberculosis lesion is of products passed for refrigeration are found in any muscle or intermuscular moved for such refrigeration to a freez- tissue, or bone, or joint, or abdominal ing facility approved by the Adminis- organ (excluding the gastrointestinal trator in specific cases: Provided, That tract) or in any lymph node as a result when so moved the products are of draining a muscle, bone, joint, or ab- shipped in containers sealed in accord- dominal organ (excluding the gastro- ance with § 318.10(c) of this subchapter intestinal tract); or in a sealed means of conveyance as (5) When the lesions are extensive in provided in § 325.7 of this subchapter. tissues of either the thoracic or the ab- Owning to the fact that it is imprac- dominal cavity; ticable to formulate rules covering (6) When the lesions are multiple, every case and to designate at just acute, and actively progressive; or what stage a disease process or a condi- (7) When the character or extent of tion results in adulteration of a prod- the lesions otherwise is not indicative uct, the decision as to the disposal of of a localized condition. all carcasses, organs, or other parts not (b) Organs or other parts condemned. specifically covered in this part shall An organ or other part of a swine, cat- be left to the veterinary medical offi- tle, sheep, goat, or equine carcass af- cer. The veterinary medical officer fected by localized tuberculosis shall shall exercise his judgment regarding be condemned when it contains lesions

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of tuberculosis or when the correspond- paragraph (e) of this section, but not so ing lymph node contains lesions of tu- severe or so numerous as the lesions berculosis. described in paragraph (a) of this sec- (c) Carcasses of cattle passed without tion, the unaffected portions of such restriction for human food. Carcasses of carcass may be passed for cooking in cattle may be passed without restric- accordance with part 315 of this chap- tion for human food only when the car- ter; if the character and extent of the cass of an animal not identified as a re- lesions indicate a localized condition, actor to a tuberculin test administered and if the lesions are calcified or en- by an Animal and Plant Health Inspec- capsulated, and provided the affected tion Service, State, or accredited vet- organ or other part is condemned. erinarian 1 is found free of tuberculosis (g) Carcasses of sheep, goats, and lesions during postmortem inspection. equines passed without restriction for (d) Portions of carcasses and carcasses human food. Carcasses of sheep, goats, of cattle passed for cooking. (1) When a and equines may be passed without re- cattle carcass reveals a tuberculosis le- striction for human food only if found sion or lesions not so severe or so nu- free of tuberculosis lesions during post merous as the lesions described in mortem inspection. paragraph (a) of this section, the unaf- (h) Portions of carcasses of sheep, goats, fected portion of the carcass may be and equines passed for cooking. If a car- passed for cooking in accordance with cass of any sheep, goat, or equine re- part 315 of this chapter; if the char- veals a tuberculosis lesion or lesions acter and extent of the lesions indicate that are not so severe or so numerous a localized condition, and if the lesions as the lesions described in paragraph are calcified or encapsulated, and pro- (a) of this section, the unaffected por- vided the affected organ or other part tion of the carcass may be passed for is condemned. cooking in accordance with part 315 of (2) When the carcass of a cattle iden- this chapter; if the character and ex- tified as a reactor to a tuberculin test tent of the lesions indicate a localized administered by an Animal and Plant condition, and if the lesions are calci- Health Inspection Service, State or ac- fied or encapsulated, and provided the credited veterinarian is found free of affected organ or other part is con- lesions of tuberculosis, the carcass may demned. be passed for cooking in accordance [37 FR 2661, Feb. 4, 1972; 38 FR 29214, Oct. 23, with part 315 of this chapter. 1973] (e) Portions of carcasses and carcasses of swine passed without restriction for § 311.3 Hog cholera. human food. Swine carcasses found free (a) The carcasses of all hogs affected of tuberculosis lesions during post with hog cholera shall be condemned. mortem inspection may be passed for (b) Inconclusive but suspicious symp- human food without restriction. When toms of hog cholera observed during tuberculosis lesions in any swine car- the ante-mortem inspection of a U.S. cass are localized and confined to one suspect shall be duly considered in con- primary seat of infection, such as the nection with post-mortem findings and cervical lymph nodes, the mesenteric when the carcass of such a suspect lymph nodes, or the mediastinal lymph shows lesions in the kidneys and the nodes, the unaffected portion of the lymph nodes which resemble lesions of carcass may be passed for human food hog cholera, they shall be regarded as without restriction after the affected those of hog cholera and the carcass organ or other part is condemned. shall be condemned. (f) Portions of carcasses of swine passed (c) When lesions resembling those of for cooking. When the carcass of any hog cholera occur in kidneys and swine reveals lesions more severe or lymph nodes of carcasses of hogs which more numerous than those described in appeared normal on ante-mortem inspection, further inspection of such 1 Such testing is conducted in the tuber- carcasses shall be made for corrobora- culosis eradication program of the Animal tive lesions. If on such further inspec- and Plant Health Inspection Service, U.S. tion, characteristic lesions of hog chol- Department of Agriculture. era are found in some organ or tissue

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in addition to those in the kidneys or human food after removal and con- in the lymph nodes or in both, then all demnation of the affected tissues, pro- lesions shall be regarded as those of vided the lesion is localized. hog cholera and the carcass shall be condemned. Immediate notification § 311.9 Actinomycosis and actinobacil- shall be given by the inspector to the losis. official in the Veterinary Services unit (a) The definition of generalization of the Animal and Plant Health Inspec- as outlined for tuberculosis in § 311.2(a) tion Service who has responsibility for shall apply for actinomycosis and acti- control of swine diseases in the State nobacillosis, and carcasses of livestock where the swine are located. with generalized lesions of either such [35 FR 15569, Oct. 3, 1970, as amended at 40 FR disease shall be condemned. 27225, June 27, 1975] (b) Carcasses of livestock in a well- nourished condition showing uncompli- § 311.5 Swine erysipelas. cated localized lesions of actinomy- Carcasses affected with swine ery- cosis or actinobacillosis may be passed sipelas which is acute or generalized, for human food after the infected or- or which show systemic change, shall gans or other infected parts have been be condemned. removed and condemned, except as provided in paragraphs (c) and (d) of this § 311.6 Diamond-skin disease. section. Carcasses of hogs affected with dia- (c) Heads affected with actinomy- mond-skin disease when localized and cosis or actinobacillosis, including the not associated with systemic change tongue, shall be condemned, except may be passed for human food after re- that when the disease of the jaw is moval and condemnation of the af- slight, strictly localized, and without fected parts, provided such carcasses suppuration, fistulous tracts, or lymph are otherwise healthy. node involvement, the tongue, if free from disease, may be passed, or, when § 311.7 Arthritis. the disease is slight and confined to the (a) Carcasses affected with arthritis lymph nodes, the head including the which is localized and not associated tongue, may be passed for human food with systemic change may be passed after the affected nodes have been re- for human food after removal and con- moved and condemned. demnation of all affected parts. Af- (d) When the disease is slight and fected joints with corresponding lymph confined to the tongue, with or without nodes shall be removed and condemned. involvement of the corresponding In order to avoid contamination of the lymph nodes, the head may be passed meat which is passed, a joint capsule for human food after removal and con- shall not be opened until after the af- demnation of the tongue and cor- fected joint is removed. responding lymph nodes. (b) Carcasses affected with arthritis shall be condemned when there is evi- § 311.10 Anaplasmosis, anthrax, babes- dence of systemic involvement. iosis, bacillary hemoglobinuria in cattle, blackleg, bluetongue, hemor- § 311.8 Cattle carcasses affected with rhagic septicemia, icterohematuria anasarca or generalized edema. in sheep, infectious bovine rhino- (a) Carcasses of cattle found on post- tracheitis, leptospirosis, malignant mortem inspection to be affected with epizootic catarrh, strangles, purpura hemorrhagica, azoturia, infec- anasarca in advanced stages and char- tious equine encephalomyelitis, acterized by an extensive or well- toxic encephalomyelitis (forage poi- marked generalized edema shall be soning), infectious anemia (swamp condemned. fever), dourine, acute influenza, (b) Carcasses of cattle, including generalized osteoporosis, glanders their detached organs and other parts, (farcy), acute inflammatory lame- found on post-mortem inspection to be ness, extensive fistula, and affected with anasarca to a lesser ex- unhealed vaccine lesions. tent than as described in paragraph (a) (a) Carcasses of livestock affected of this section may be passed for with or showing lesions of any of the

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following named diseases or conditions tirety if one of the following three con- shall be condemned: ditions exists: (1) Anthrax. (1) The affection has involved the os- (2) Blackleg. seous structures of the head with ex- (3) Unhealed vaccine lesions tensive infection, suppuration, and ne- (vaccinia). crosis; (4) Strangles. (2) There is metastasis from the eye, (5) Purpura hemorrhagica. or the orbital region, to any lymph (6) Azoturia. node including the parotid lymph node, (7) Infectious equine encephalomye- internal organs, muscles, skeleton, or litis. other structures, regardless of the ex- (8) Toxic encephalomyelitis (forage tent of the primary tumor; or poisoning). (3) The affection, regardless of ex- (9) Infectious anemia (swamp fever). tent, is associated with cachexia or evi- (10) Dourine. dence of absorption or secondary (11) Acute influenza. changes. (12) Generalized osteoporosis. (b) Carcasses of animals affected with (13) Glanders (farcy). epithelioma of the eye, or the orbital (14) Acute inflammatory lameness. region, to a lesser extent than as de- (15) Extensive fistula. scribed in paragraph (a) of this section (b) Carcasses of livestock affected may be passed for human food after re- with or showing lesions of any of the moval and condemnation of the head, following named diseases or conditions including the tongue, provided the car- shall be condemned, except when re- cass is otherwise normal. covery has occurred to the extent that only localized lesions persist, in which § 311.13 Pigmentary conditions; mela- case the carcass may be passed for nosis, xanthosis, ochronosis, etc. human food after removal and con- (a) Except as provided in § 311.19, car- demnation of the affected organs or casses of livestock showing generalized other parts: pigmentary deposits shall be con- (1) Anaplasmosis. demned. (2) Bacillary hemoglobinuria in cat- (b) The affected parts of carcasses tle. showing localized pigmentary deposits (3) Babesiosis (piroplasmosis). of such character as to be unwholesome (4) Bluetongue. or otherwise adulterated shall be re- (5) Hemorrhagic septicemia. moved and condemned. (6) Icterohematuria in sheep. (7) Infectious bovine rhinotracheitis. § 311.14 Abrasions, bruises, abscesses, (8) Leptospirosis. pus, etc. (9) Malignant epizootic catarrh. All slight, well-limited abrasions on [35 FR 15569, Oct. 3, 1970, as amended at 36 FR the tongue and inner surface of the lips 12004, June 24, 1971] and mouth, when without lymph node involvement, shall be carefully excised, § 311.11 Neoplasms. leaving only sound, normal tissue, (a) An individual organ or other part which may be passed for human food. of a carcass affected with a neoplasm Any organ or other part of a carcass shall be condemned. If there is evi- which is badly bruised or which is af- dence of metastasis or that the general fected by an abscess, or a suppurating condition of the animal has been ad- sore shall be condemned; and when the versely affected by the size, position, lesions are of such character or extent or nature of the neoplasm, the entire as to affect the whole carcass, the carcass shall be condemned. whole carcass shall be condemned. Por- (b) Carcasses affected with malignant tions of carcasses which are contami- lymphoma shall be condemned. nated by pus or other diseased material shall be condemned. § 311.12 Epithelioma of the eye. (a) Carcasses of animals affected with § 311.15 Brucellosis. epithelioma of the eye, or the orbital Carcasses affected with localized le- region shall be condemned in their en- sions of brucellosis may be passed for

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human food after the affected parts are lesions are removed and condemned. removed and condemned. However, when emaciation, cloudy swelling of the parenchymatous tissue § 311.16 Carcasses so infected that con- of organs or enlargement of the lymph sumption of the meat may cause nodes is associated with the infection, food poisoning. it is evident that the disease has pro- (a) All carcasses of animals so in- gressed beyond the condition of local- fected that consumption of the prod- ization to a state of toxemia, and the ucts thereof may give rise to food poi- entire carcass shall therefore be con- soning shall be condemned. This in- demned as both unwholesome and nox- cludes all carcasses showing signs of: ious. Pyemia or septicemia may inter- (1) Acute inflammation of the lungs, vene as a complication of the local ne- pleura, pericardium, peritoneum, or crosis, and when present the carcass meninges. shall be condemned in accordance with (2) Septicemia or pyemia, whether § 311.16. puerperal, traumatic, or without any evident cause. § 311.18 Caseous lymphadenitis. (3) Gangrenous or severe hemorrhagic (a) A thin carcass showing well- enteritis or gastritis. marked lesions in the viscera and the (4) Acute diffuse metritis or mam- skeletal lymph nodes, or a thin carcass mitis. showing extensive lesions in any part (5) Phlebitis of the umbilical veins. shall be condemned. (6) Septic or purulent traumatic peri- (b) A thin carcass showing well- carditis. marked lesions in the viscera with only (7) Any acute inflammation, abscess, slight lesions elsewhere or showing or suppurating sore, if associated with well-marked lesions in the skeletal acute nephritis, fatty and degenerated lymph nodes with only slight lesions liver, swollen soft spleen, marked pul- elsewhere may be passed for cooking. monary hyperemia, general swelling of (c) A thin carcass showing only slight lymph nodes, diffuse redness of the lesions in the skeletal lymph nodes and skin, cachexia, icteric discoloration of in the viscera may be passed for human the carcass or similar condition, either food without restriction. singly or in combination. (d) A well-nourished carcass showing (8) Salmonellosis. well-marked lesions in the viscera and (b) Implements contaminated by con- with only slight lesions elsewhere or tact with carcasses affected with any showing well-marked lesions confined of the disease conditions mentioned in to the skeletal lymph nodes with only this section shall be thoroughly slight lesions elsewhere may be passed cleaned and sanitized as prescribed in for human food without restriction. part 308 of this subchapter. The equip- (e) A well-nourished carcass showing ment used in the dressing of such car- well-marked lesions in the viscera and casses, such as viscera trucks or in- the skeletal lymph nodes may be spection tables, shall be sanitized with passed for cooking; but where the le- hot water having a minimum tempera- sions in a well-nourished carcass are ture of 180 °F. Carcasses or parts of car- both numerous and extensive, it shall casses contaminated by contact with be condemned. such diseased carcasses shall be con- (f) All affected organs and nodes of demned unless all contaminated tissues carcasses passed for human food with- are removed within 2 hours. out restriction or passed for cooking shall be removed and condemned. § 311.17 Necrobacillosis, pyemia, and (g) As used in this section, the term septicemia. ‘‘thin’’ does not apply to a carcass From the standpoint of meat inspec- which is anemic or emaciated; and the tion, necrobacillosis may be regarded term ‘‘lesions’’ refers to lesions of case- as a local infection at the beginning, ous lymphadenitis. and carcasses in which the lesions are localized may be passed for human food § 311.19 Icterus. if in a good state of nutrition, after Carcasses showing any degree of ic- those portions affected with necrotic terus shall be condemned. Yellow fat

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conditions caused by nutritional fac- posing the musculature in cross sec- tors or characteristic of certain breeds tion, and (ii) a transverse incision into of livestock and yellow fat sometimes each forelimb commencing 2 or 3 seen in sheep shall not be confused inches above the point of the olecranon with icterus. Such carcasses should be and extending to the humerus. passed for human food, if otherwise (2) Carcasses of cattle showing one or normal. more tapeworm lesions of cysticercus bovis but not so extensive as indicated § 311.20 Sexual odor of swine. in paragraph (a)(1) of this section, as (a) Carcasses of swine which give off determined by a careful examination, a pronounced sexual odor shall be con- including examination of, but not lim- demned. ited to, the heart, diaphragm and its (b) The meat of swine carcasses pillars, muscles of mastication, esopha- which give off a sexual odor less than gus, tongue, and musculature exposed pronounced may be passed for use in comminuted cooked meat food product during normal dressing operations, or for rendering. Otherwise it shall be may be passed for human food after re- condemned. moval and condemnation of the lesions with surrounding tissues: Provided, § 311.21 Mange or scab. That the carcasses, appropriately iden- Carcasses of livestock affected with tified by retained tags, are held in cold mange or scab in advanced stages, storage under positive control of a showing cachexia or extensive inflam- USDA Food Inspector at a temperature mation of the flesh, shall be con- not higher than 15 °F. continuously for demned. When the disease is slight, the a period of not less than 10 days, or in carcass may be passed after removal of the case of boned meat derived from the affected portion. such carcasses, the meat, when in boxes, tierces, or other containers, ap- § 311.22 Hogs affected with urticaria, propriately identified by retained tags, tinea tonsurans, demodex follicur- is held under positive control of a Pro- lorum, or erythema. gram Inspector at a temperature of not Carcasses of hogs affected with urti- higher than 15 °F. continuously for a caria (nettle rash), tinea tonsurans, period of not less than 20 days. As an demodex folliculorum, or erythema alternative to retention in cold storage may be passed for human food after de- as provided in this subparagraph, such taching and condemning the affected carcasses and meat may be heated skin, if the carcass is otherwise not adulterated. throughout to a temperature of at least 140 °F. under positive control of a § 311.23 Tapeworm cysts (cysticercus Program Inspector. bovis) in cattle. (b) Edible viscera and offal shall be (a) Except as provided in paragraph disposed of in the same manner as the (b) of this section, carcasses of cattle rest of the carcass from which they affected with lesions of cysticercus were derived unless any lesion of bovis shall be disposed of as follows: cysticercus bovis is found in these by- (1) Carcasses of cattle displaying le- products, in which case they shall be sions of cysticercus bovis shall be con- condemned. demned if the infestation is extensive or if the musculature is edematous or [36 FR 4591, Mar. 10, 1971] discolored. Carcasses shall be consid- § 311.24 Hogs affected with tapeworm ered extensively infested if in addition cysts. to finding lesions in at least two of the usual inspection sites, namely the Carcasses of hogs affected with tape- heart, diaphragm and its pillars, mus- worm cysts (Cysticercus cellulosae) cles of mastication, esophagus, tongue, may be passed for cooking, unless the and musculature exposed during nor- infestation is excessive, in which case mal dressing operations, they are found the carcass shall be condemned. in at least two of the sites exposed by (i) an incision made into each round ex-

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§ 311.25 Parasites not transmissible to Multiceps multiceps) may be passed for man; tapeworm cysts in sheep; human food after condemnation of the hydatid cysts; flukes; gid bladder- affected organ (brain or spinal cord). worms. (d) Organs or other parts of carcasses (a) In the disposal of carcasses, edible infested with hydatid cysts organs, and other parts of carcasses (echinococus) shall be condemned. showing evidence of infestation with (e) Livers infested with flukes or parasites not transmissible to man, the fringed tapeworms shall be condemned. following general rules shall govern except as otherwise provided in this sec- § 311.26 Emaciation. tion: If the lesions are localized in such Carcasses of livestock too emaciated manner and are of such character that to produce wholesome meat, and car- the parasites and the lesions caused by casses which show a serous infiltration them can be completely removed, the of muscle tissues, or a serous or mu- nonaffected portion of the carcass, coid degeneration of the fatty tissue, organ, or other part of the carcass may shall be condemned. A gelatinous be passed for human food after the re- change of the fat of the heart and kid- moval and condemnation of the af- neys of well-nourished carcasses and fected portions. If an organ or other mere leanness shall not be classed as part of a carcass shows numerous le- emaciation. sions caused by parasites, or if the [35 FR 15569, Oct. 3, 1970; 36 FR 11903, June 23, character of the infestation is such 1971] that complete extirpation of the parasitic infestation or invasion renders § 311.27 Injured animals slaughtered the part in any way unfit for human at unusual hours. food, the affected part shall be con- When it is necessary for humane rea- demned. If parasites are found to be sons to slaughter an injured animal at distributed in a carcass in such a man- night or on Sunday or a holiday when ner or to be of such character that the inspector cannot be obtained, the their removal and the removal of the carcass and all parts shall be kept for lesions caused by them is impractica- inspection, with the head and all ble, no part of the carcass shall be viscera except the stomach, bladder, passed for human food. If the infesta- and intestines held by the natural at- tion is excessive, the carcass shall be tachments. If all parts are not so kept condemned. If the infestation is mod- for inspection, the carcass shall be con- erate, the carcass may be passed for demned. If, on inspection of a carcass cooking, but in case such carcass is not slaughtered in the absence of an in- cooked as required by part 315 of this spector, any lesion or other evidence is subchapter, it shall be condemned. found indicating that the animal was (b) In the case of sheep carcasses af- sick or diseased, or affected with any fected with tapeworm cysts (Cysticer- other condition requiring condemna- cus ovis, so-called sheep measles, not tion of the animal on ante-mortem in- transmissible to man), such carcasses spection, or if there is lacking evidence may be passed for human food after the of the condition which rendered emer- removal and condemnation of the af- gency slaughter necessary, the carcass fected portions: Provided, however, That shall be condemned. if, upon the final inspection of sheep carcasses retained on account of mea- § 311.28 Carcasses of young calves, sles, the total number of cysts found pigs, kids, lambs, and foals. embedded in muscular tissue, or in im- Carcasses of young calves, pigs, kids, mediate relation with muscular tissue, lambs, and foals are unwholesome and excluding the heart, exceeds five, the shall be condemned if (a) the meat has entire carcass shall be condemned, or the appearance of being water-soaked, such carcass shall be heated through- is loose, flabby, tears easily, and can be out to a temperature of at least 140 °F. perforated with the fingers; or (b) its After removal and condemnation of all color is grayish-red; or (c) good mus- affected portions. cular development as a whole is lack- (c) Carcasses found infested with gid ing, especially noticeable on the upper bladder-worms (Coenurus cerebralis, shank of the leg, where small amounts

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of serous infiltrates or small edema- may be shipped from an official estab- tous patches are sometimes present be- lishment for purposes other than tween the muscles; or (d) the tissue human food in accordance with § 314.10 which later develops as the fat capsule of this subchapter. of the kidneys is edematous, dirty yellow, or grayish-red, tough, and § 311.32 Vesicular diseases. intermixed with islands of fat. (a) Any carcass affected with vesicular disease shall be condemned if the § 311.29 Unborn and stillborn animals. condition is acute and if the extent of All unborn and stillborn animals the condition is such that it affects the shall be condemned and no hide or skin entire carcass or there is evidence of thereof shall be removed from the car- absorption or secondary change. cass within a room in which edible (b) Any carcass affected with vesicu- products are handled. lar disease to a lesser extent than as described in paragraph (a) of this sec- § 311.30 Livestock suffocated and hogs tion may be passed for human food scalded alive. after removal and condemnation of the All livestock which have been suffo- affected parts, if the carcass is other- cated in any way and hogs which have wise healthy. entered the scalding vat alive shall be condemned. § 311.33 Listeriosis.

§ 311.31 Livers affected with caroten- Carcasses of livestock identified as osis; livers designated as U.S. Suspects because of a history of ‘‘telangiectatic,’’ ‘‘sawdust,’’ or listeriosis shall be passed for human ‘‘spotted.’’ food after condemnation of the head if (a) Livers affected with carotenosis the carcass is otherwise normal. shall be condemned. § 311.34 Anemia. (b) Cattle livers and calf livers showing the conditions sometimes des- Carcasses of livestock too anemic to ignated as ‘‘telangiectatic,’’ ‘‘saw- produce wholesome meat shall be con- dust,’’ or ‘‘spotted’’ shall be disposed of demned. as follows: (1) When any or all of the conditions § 311.35 Muscular inflammation, de- are slight in the organ, the whole generation, or infiltration. organ shall be passed for human food (a) If muscular lesions are found to without restriction. be distributed in such a manner or to (2) When any or all of the conditions be of such character that removal is are more severe than slight and involve impractical, the carcass shall be con- less than one-half of the organ, while demned. in the remainder of the organ the con- (b) If muscular lesions are found to ditions are slight or nonexistent, the be distributed in such a manner or to remainder shall be passed for human be of such character that removal is food without restriction and the other practical, the following rules shall gov- portion shall be condemned. ern the disposal of the carcasses, edible (3) When any or all of the conditions organs, and other parts of carcasses are more severe than slight and involve showing such muscular lesions. If the one-half or more of the organ, the lesions are localized in such a manner whole organ shall be condemned. and are of such a character that the af- (4) The divisions of an organ into two fected tissues can be removed, the non- parts as contemplated in this para- affected parts of the carcass may be graph for disposition, shall be accom- passed for human food after the re- plished by one cut through the organ. moval and condemnation of the af- This, of course, does not prohibit inci- fected portion. If a part of the carcass sions which are necessary for inspec- shows numerous lesions, or if the char- tion. acter of the lesion is such that com- (c) ‘‘Telangiectatic,’’ ‘‘sawdust,’’ or plete extirpation is difficult and uncer- ‘‘spotted’’ livers and parts of livers tainly accomplished, or if the lesion which are condemned for human food renders the part in any way unfit for

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human food, the part shall be con- PART 312—OFFICIAL MARKS, demned. DEVICES AND CERTIFICATES (c) If the lesions are slight or of such character as to be insignificant from a Sec. standpoint of wholesomeness, the car- 312.1 General. cass or parts may be passed for use in 312.2 Official marks and devices to identify the manufacture of comminuted inspected and passed products of cattle, cooked product, after removal and con- sheep, swine, or goats. demnation of the visibly affected por- 312.3 Official marks and devices to identify tions. inspected and passed equine products. 312.4 Official ante-mortem inspection § 311.36 Coccidioidal granuloma. marks and devices. 312.5 Official seals for transportation of (a) Carcasses which are affected with products. generalized coccidioidal granuloma or 312.6 Official marks and devices in connec- which show systemic changes because tion with post-mortem inspection and of such disease shall be condemned. identification of adulterated products and insanitary equipment and facilities. (b) Carcasses affected with localized 312.7 [Reserved] lesions of this disease may be passed 312.8 Official export inspection marks, de- for human food after the affected parts vices, and certificates. are removed and condemned. 312.9 Official detention marks and devices. 312.10 Official mark for maintaining the § 311.37 Odors, foreign and urine. identity and integrity of samples.

(a) Carcasses which give off a pro- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, nounced odor of medicinal, chemical, 2.55. or other foreign substance shall be con- SOURCE: 35 FR 15573, Oct. 3, 1970, unless demned. otherwise noted. (b) Carcasses which give off a pronounced urine odor shall be con- § 312.1 General. demned. The marks, devices, and certificates (c) Carcasses, organs, or parts af- prescribed or referenced in this part fected by odor to a lesser degree than shall be official marks, devices, and as described in paragraphs (a) and (b) of certificates for purposes of the Act, and this section and in which the odor can shall be used in accordance with the be removed by trimming or chilling provisions of this part and the regula- may be passed for human food, after re- tions cited therein. moval of affected parts or dissipation of the condition. § 312.2 Official marks and devices to identify inspected and passed prod- § 311.38 Meat and meat byproducts ucts of cattle, sheep, swine, or from livestock which have been ex- goats. posed to radiation. (a) The official inspection legend re- Meat and meat byproducts from live- quired by Part 316 of this subchapter to stock which have been administered ra- be applied to inspected and passed car- dioactive material shall be condemned casses and parts of carcasses of cattle, unless the use of the radiation was in sheep, swine and goats, meat food prod- conformity with a regulation or exemp- ucts in animal casings, and other prod- tion in effect pursuant to section 409 of ucts as approved by the Administrator, the Federal Food, Drug, and Cosmetic shall be in the appropriate form as Act. hereinafter specified: 1

§ 311.39 Biological residues. Carcasses, organs, or other parts of carcasses of livestock shall be con- 1 The number ‘‘38’’ is given as an example demned if it is determined that they only. The establishment number of the offi- are adulterated because of the presence cial establishment where the product is pre- of any biological residues. pared shall be used in lieu thereof.

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For application to sheep carcasses, the loins and ribs of pork, beef tails, and the smaller varieties of sausage and meat food products in animal casings.

For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses. (b)(1) The official inspection legend For application to calf and goat car- required by Part 317 of this subchapter casses and on the larger varieties of to be shown on all labels for inspected sausage and meat food products in ani- and passed products of cattle, sheep, mal casings. swine, and goats shall be in the following form 1 except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated:

For application to beef and hog carcasses primal parts and cuts therefrom, beef livers, beef tongues, beef hearts, and smoked meats not in casings.

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containers, band labels, artificial casings, and other articles with the approval of the Administrator. (c) Any brand, stamp, label, or other device approved by the Administrator and bearing any official mark prescribed in paragraphs (a) or (b) of this section shall be an official device for purposes of the Act.

[35 FR 15573, Oct. 3, 1970; 36 FR 12002, June 24, 1971]

§ 312.3 Official marks and devices to identify inspected and passed equine products. (a) The official inspection legend required by § 316.12 or § 317.2 of this sub- (b) The official inspection legend re- chapter to identify inspected and quired by § 316.12 or § 317.2 of this sub- passed horse carcasses and parts of car- chapter to identify inspected and casses, or horse meat food products passed mule and other (nonhorse) shall be in the appropriate form as equine carcasses and parts of carcasses, hereinafter specified: 1 or equine meat food products shall be in whichever of the following form, is appropriate:1

1 The number ‘‘38’’ is given as an example only. The establishment number of the official establishment where the product is prepared shall be used in lieu thereof.

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§ 312.4 Official ante-mortem inspection marks and devices. The official marks and devices used in connection with ante-mortem inspection are those prescribed in § 309.18 of this subchapter.

§ 312.5 Official seals for transportation of products. The official mark for use in sealing railroad cars or other means of conveyance as prescribed in Part 325 of this subchapter shall be the inscription and a serial number as hereinafter shown 2 and any seal approved by the Adminis- trator for applying such mark shall be (c) Any brand, stamp, label, or other an official device for purposes of the device approved by the Administrator Act. This seal shall be attached to the and bearing any official mark pre- means of conveyance only by a Pro- scribed in paragraphs (a) or (b) of this gram employee and he shall also affix section shall be an official device for thereto a ‘‘Warning Tag’’ (Form MP– purposes of the Act. 408–3).

[35 FR 15573, Oct. 3, 1970, as amended at 39 FR 36000, Oct. 7, 1974; 51 FR 37707, Oct. 24, 1986]

§ 312.6 Official marks and devices in prescribed in part 310 of this sub- connection with post-mortem in- chapter by means of a paper tag (Form spection and identification of adul- MP–35) bearing the legend ‘‘U.S. Re- terated products and insanitary tained.’’ equipment and facilities. (3) The ‘‘U.S. Rejected’’ mark which (a) The official marks required by is used to identify insanitary buildings, parts 308 and 310 of this subchapter for rooms, or equipment as prescribed in use in post-mortem inspection and Part 308 of this subchapter and is ap- identification of adulterated products plied by means of a paper tag (Form and insanitary equipment and facilities MP–35) bearing the legend ‘‘U.S. Re- are: jected.’’ (1) The tag (Form MP–427) which is (4) The ‘‘U.S. Passed for Cooking’’ used to retain carcasses and parts of mark is applied on products passed for carcasses in the slaughter department; cooking as prescribed in part 310 of this it is black and white, and bears the leg- subchapter by means of a brand and is end ‘‘U.S. Retained.’’ in the following form: (2) The ‘‘U.S. Retained’’ mark which is applied to products and articles as

2 The number ‘‘2135202’’ is given as an example only. The serial number of the specific seal will be shown in lieu thereof.

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this paragraph shall be an official device for the purposes of the Act. (b) The official export certificate required by part 322 of this subchapter is a paper certificate form for signature by a Program employee, bearing a let- (5) The ‘‘U.S. Inspected and Con- terhead and the seal of the United demned’’ mark shall be applied to prod- States Department of Agriculture, ucts condemned as prescribed in part with a certification that meat or meat 310 by means of a brand and is in the food products described on the form is following form: from animals that received ante- mortem and post-mortem inspection and were found sound and healthy and that it has been inspected and passed as provided by law and the regulations of the Department of Agriculture and is sound and wholesome. The certificate also bears a serial number such as (b) The U.S. Retained and U.S. Re- ‘‘No. 184432.’’ jected tags, and all other brands, [35 FR 15573, Oct. 3, 1970, as amended at 42 FR stamps, labels, and other devices ap- 11825, Mar. 1, 1977; 47 FR 29823, July 9, 1982] proved by the Administrator and bearing any official mark prescribed in § 312.9 Official detention marks and paragraph (a) of this section, shall be devices. official devices for purposes of the Act. The official mark for articles and [35 FR 15573, Oct. 3, 1970, as amended at 38 FR livestock detained under part 329 of 29214, Oct. 23, 1973; 39 FR 36000; Oct. 7, 1974; 43 this subchapter shall be the designa- FR 29268, July 7, 1978] tion ‘‘U.S. Detained’’ and the official § 312.7 [Reserved] device for applying such mark shall be the official ‘‘U.S. Detained’’ tag (FSIS § 312.8 Official export inspection Form 8400–2) as prescribed in § 329.2 of marks, devices, and certificates. this subchapter.

(a) The official export meat inspec- [55 FR 47842, Nov. 16, 1990] tion mark required by part 322 of this subchapter shall be in the following § 312.10 Official mark for maintaining form as hereinafter specified: 1 the identity and integrity of samples. The official mark for use in sealing containers of samples submitted under any requirements in this subchapter and section 202 of the Federal Meat In- spection Act shall bear the designation ‘‘Sample Seal’’ accompanied by the official USDA logo as shown below. Any seal approved by the Administrator for applying such mark shall be deemed an official device for purposes of the Act. Any rubber stamp approved by the Ad- Such device shall be supplied to inspec- ministrator, in the manner provided tors, compliance officers, and other for in part 317 of this subchapter, and designated Agency officials by the bearing the official mark prescribed in United States Department of Agri- culture. 1 The number ‘‘529893’’ is given as an example only. The number of the offical export certificate will be shown in lieu thereof.

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disabled livestock (as defined in § 301.2(y)) shall be provided with a covered pen sufficient, in the opinion of the inspector, to protect them from the adverse climatic conditions of the lo- cale while awaiting disposition by the inspector. (d) Livestock pens and driveways shall be so arranged that sharp corners and direction reversal of driven animals are minimized. [44 FR 68813, Nov. 30, 1979, as amended at 53 FR 49848, Dec. 12, 1988]

[52 FR 41958, Nov. 2, 1987] § 313.2 Handling of livestock. (a) Driving of livestock from the un- PART 313—HUMANE SLAUGHTER loading ramps to the holding pens and OF LIVESTOCK from the holding pens to the stunning area shall be done with a minimum of Sec. excitement and discomfort to the ani- 313.1 Livestock pens, driveways, and ramps. mals. Livestock shall not be forced to 313.2 Handling of livestock. move faster than a normal walking 313.5 Chemical; carbon dioxide speed. 313.15 Mechanical; captive bolt. (b) Electric prods, canvas slappers, or 313.16 Mechanical; gunshot. other implements employed to drive 313.30 Electrical; stunning or slaughtering animals shall be used as little as pos- with electric current. 313.50 Tagging of equipment, alleyways, sible in order to minimize excitement pens or compartments to prevent inhu- and injury. Any use of such imple- mane slaughter or handling in connec- ments which, in the opinion of the in- tion with slaughter. spector, is excessive, is prohibited. 313.90 [Reserved] Electrical prods attached to AC house AUTHORITY: 7 U.S.C. 1901–1906; 21 U.S.C. 601– current shall be reduced by a trans- 695; 7 CFR 2.17, 2.55. former to the lowest effective voltage not to exceed 50 volts AC. SOURCE: 44 FR 68813, Nov. 30, 1979, unless otherwise noted. (c) Pipes, sharp or pointed objects, and other items which, in the opinion § 313.1 Livestock pens, driveways and of the inspector, would cause injury or ramps. unnecessary pain to the animal shall (a) Livestock pens, driveways and not be used to drive livestock. ramps shall be maintained in good re- (d) Disabled livestock and other ani- pair. They shall be free from sharp or mals unable to move. protruding objects which may, in the (1) Disabled animals and other ani- opinion of the inspector, cause injury mals unable to move shall be separated or pain to the animals. Loose boards, from normal ambulatory animals and splintered or broken planking, and un- placed in the covered pen provided for necessary openings where the head, in § 313.1(c). feet, or legs of an animal may be in- (2) The dragging of disabled animals jured shall be repaired. and other animals unable to move, (b) Floors of livestock pens, ramps, while conscious, is prohibited. Stunned and driveways shall be constructed and animals may, however, be dragged. maintained so as to provide good foot- (3) Disabled animals and other ani- ing for livestock. Slip resistant or waf- mals unable to move may be moved, fled floor surfaces, cleated ramps and while conscious, on equipment suitable the use of sand, as appropriate, during for such purposes; e.g., stone boats. winter months are examples of accept- (e) Animals shall have access to able conctruction and maintenance. water in all holding pens and, if held (c) U.S. Suspects (as defined in longer than 24 hours, access to feed. § 301.2(xxx)) and dying, diseased, and There shall be sufficient room in the

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holding pen for animals held overnight carbon dioxide gas shall be adminis- to lie down. tered in a tunnel which is designed to (f) Stunning methods approved in permit the effective exposure of the § 313.30 shall be effectively applied to animal. Two types of tunnels, based on animals prior to their being shackled, the same principle, are in common use hoisted, thrown, cast, or cut. for carbon dioxide anesthesia. They are the ‘‘U’’ type tunnel and the ‘‘Straight § 313.5 Chemical; carbon dioxide. Line’’ type tunnel, and are based on The slaughtering of sheep, calves and the principle that carbon dioxide gas swine with the use of carbon dioxide has a higher specific gravity than air. gas and the handling in connection The tunnels are open at both ends for therewith, in compliance with the pro- entry and exit of animals and have a visions contained in this section, are depressed central section. Anesthetiz- hereby designated and approved as hu- ing, or, in the case of swine, death-in- mane methods of slaughtering and han- ducing, carbon dioxide concentrations dling of such animals under the Act. are maintained in the central sections (a) Administration of gas, required ef- of the tunnels. Effective anaestheti- fect; handling. (1) The carbon dioxide zation is produced in these central sec- gas shall be administered in a chamber tions. Animals are driven from holding in accordance with this section so as to pens through pathways constructed of produce surgical anesthesia in the ani- large-diameter pipe or smooth metal mals before they are shackled, hoisted, and onto continuous conveyor devices thrown, cast, or cut. The animals shall that move the animals through the be exposed to the carbon dioxide gas in tunnels. The animals are either com- a way that will accomplish the anes- partmentalized on the conveyors by thesia quickly and calmly, with a min- mechanical impellers synchronized imum of excitement and discomfort to with the conveyor or they are other- the animals. In swine, carbon dioxide wise prevented from crowding. While may be administered to induce death in impellers are used to compartmen- the animals before they are shackled, talize the animals, mechanically or hoisted, thrown, cast, or cut. manually operated gates are used to (2) The driving or conveying of the move the animals onto the conveyors. animals to the carbon dioxide chamber Surgically anaesthetized animals, or shall be done with a minimum of excitement and discomfort to the ani- killed swine, are moved out of the tun- mals. Delivery of calm animals to the nels by the same continuous conveyors anesthesia chamber is essential since that moved them into and through the the induction, or early phase, of anes- carbon dioxide gas. thesia is less violent with docile ani- (ii) Flow of animals into and through mals. Among other things this requires the carbon dioxide chamber is depend- that, in driving animals to the anesthe- ent on one operator. The operation or sia chamber, electrical equipment be stoppage of the conveyor is entirely de- used as little as possible and with the pendent upon this operator. It is nec- lowest effective voltage. essary that he be skilled, attentive, (3) On emerging from the carbon di- and aware of his responsibility. Over- oxide tunnel, the animals shall be in a dosages and death of animals can be state of surgical anaesthesia and shall brought about by carelessness of this remain in this condition throughout individual. shackling, sticking, and bleeding, ex- (2) Special requirements for gas chamber cept for swine in which death has been and auxiliary equipment. The ability of induced by the administration of car- anesthetizing equipment to perform bon dioxide. Asphyxia or death from with maximum efficiency is dependent any cause shall not be produced in ani- on its proper design and efficient me- mals before bleeding, except for swine chanical operation. Pathways, com- in which death has been induced by the partments, gas chambers, and all other administration of carbon dioxide. equipment used must be designed to ac- (b) Facilities and procedures—(1) Gen- commodate properly the species of ani- eral requirements for gas chambers and mals being anesthetized. They shall be auxiliary equipment; operator. (i) The free from pain-producing restraining

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devices. Injury of animals must be pre- carbon dioxide concentrations in the vented by the elimination of sharp pro- gas tunnel or contamination of the am- jections or exposed wheels or gears. bient air of the establishment will be There shall be no unnecessary holes, prevented. spaces or openings where feet or legs of [44 FR 68813, Nov. 30, 1979, as amended at 59 animals may be injured. Impellers or FR 21640, Apr. 26, 1994] other devices designed to mechanically move or drive animals or otherwise § 313.15 Mechanical; captive bolt. keep them in motion or compartmen- The slaughtering of sheep, swine, talized shall be constructed of flexible goats, calves, cattle, horses, mules, and or well padded rigid material. Power other equines by using captive bolt activated gates designed for constant stunners and the handling in connec- flow of animals to anesthetizing equip- tion therewith, in compliance with the ment shall be so fabricated that they provisions contained in this section, will not cause injury. All equipment in- are hereby designated and approved as volved in anesthetizing animals shall humane methods of slaughtering and be maintained in good repair. handling of such animals under the (3) Gas. Maintenance of a uniform Act. carbon dioxide concentration and dis- (a) Application of stunners, required ef- tribution in the anesthesia chamber is fect; handling. (1) The captive bolt stun- a vital aspect of producing surgical an- ners shall be applied to the livestock in esthesia. This may be assured by rea- accordance with this section so as to sonably accurate instruments which produce immediate unconsciousness in sample and analyze carbon dioxide gas the animals before they are shackled, concentration within the chamber hoisted, thrown, cast, or cut. The ani- throughout anesthetizing operations. mals shall be stunned in such a manner Gas concentration shall be maintained that they will be rendered unconscious uniform so that the degree of anesthe- with a minimum of excitement and dis- sia in exposed animals will be constant. comfort. Carbon dioxide gas supplied to anesthe- (2) The driving of the animals to the sia chambers may be from controlled stunning area shall be done with a min- reduction of solid carbon dioxide or imum of excitement and discomfort to from a controlled liquid source. In ei- the animals. Delivery of calm animals ther case the carbon dioxide shall be to the stunning areas is essential since supplied at a rate sufficient to anes- accurate placement of stunning equip- thetize adequately and uniformly the ment is difficult on nervous or injured number of animals passing through the animals. Among other things, this re- chamber. Sampling of gas for analysis quires that, in driving animals to the shall be made from a representative stunning areas, electrical equipment be place or places within the chamber and used as little as possible and with the on a continuing basis. Gas concentra- lowest effective voltage. tions and exposure time shall be (3) Immediately after the stunning graphically recorded throughout each blow is delivered the animals shall be day’s operation. Neither carbon dioxide in a state of complete unconsciousness nor atmospheric air used in the anes- and remain in this condition through- thesia chambers shall contain noxious out shackling, sticking and bleeding. or irritating gases. Each day before (b) Facilities and procedures—(1) Gen- equipment is used for anesthetizing eral requirements for stunning facilities; animals, proper care shall be taken to operator. (i) Acceptable captive bolt mix adequately the gas and air within stunning instruments may be either the chamber. All gas producing and skull penetrating or nonpenetrating. control equipment shall be maintained The latter type is also described as a in good repair and all indicators, in- concussion or mushroom type stunner. struments, and measuring devices must Penetrating instruments on detonation be available for inspection by Program deliver bolts of varying diameters and inspectors during anesthetizing oper- lengths through the skull and into the ations and at other times. An exhaust brain. Unconsciousness is produced im- system must be provided so that, in mediately by physical brain destruc- case of equipment failure, non-uniform tion and a combination of changes in

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intracranial pressure and acceleration shall be so designed that they will com- concussion. Nonpenetrating or mush- fortably accommodate the kinds of ani- room stunners on detonation deliver a mals to be stunned. bolt with a flattened circular head (iv) The stunning operation is an ex- against the external surface of the ani- acting procedure and requires a well- mal’s head over the brain. Diameter of trained and experienced operator. He the striking surface of the stunner may must be able to accurately place the vary as conditions require. Uncon- stunning instrument to produce imme- sciousness is produced immediately by diate unconsciousness. He must use the a combination of acceleration concus- correct detonating charge with regard sion and changes in intracranial pres- to kind, breed, size, age, and sex of the sures. A combination instrument uti- animal to produce the desired results. lizing both penetrating and nonpene- (2) Special requirements. Choice of in- trating principles is acceptable. Ener- strument and force required to produce gizing of instruments may be accom- immediate unconsciousness varies, de- plished by detonation of measured pending on kind, breed, size, age, and charges of gunpowder or accurately sex of the animal. Young swine, lambs, controlled compressed air. Captive and calves usually require less stun- bolts shall be of such size and design ning force than mature animals of the that, when properly positioned and ac- same kind. Bulls, rams, and boars usu- tivated, immediate unconsciousness is ally require skull penetration to produced. produce immediate unconsciousness. (ii) To assure uniform unconscious- Charges suitable for smaller kinds of ness with every blow, compressed air livestock such as swine or for young devices must be equipped to deliver the animals are not acceptably inter- necessary constant air pressure and changed for use on larger kinds or must have accurate, constantly operat- older livestock, respectively. ing air pressure gauges. Gauges must be easily read and conveniently located § 313.16 Mechanical; gunshot. for use by the stunning operator and The slaughtering of cattle, calves, the inspector. For purposes of protect- sheep, swine, goats, horses, mules, and ing employees, inspectors, and others, other equines by shooting with fire- it is desirable that any stunning device arms and the handling in connection be equipped with safety features to pre- therewith, in compliance with the pro- vent injuries from accidental dis- visions contained in this section, are charge. Stunning instruments must be hereby designated and approved as hu- maintained in good repair. mane methods of slaughtering and han- (iii) The stunning area shall be so de- dling of such animals under the Act. signed and constructed as to limit the (a) Utilization of firearms, required ef- free movements of animals sufficiently fect; handling. (1) The firearms shall be to allow the operator to locate the employed in the delivery of a bullet or stunning blow with a high degree of ac- projectile into the animal in accord- curacy. All chutes, alleys, gates and re- ance with this section so as to produce straining mechanisms between and in- immediate unconsciousness in the ani- cluding holding pens and stunning mal by a single shot before it is shack- areas shall be free from pain-producing led, hoisted, thrown, cast, or cut. The features such as exposed bolt ends, animal shall be shot in such a manner loose boards, splintered or broken that they will be rendered unconscious planking, and protruding sharp metal with a minimum of excitement and dis- of any kind. There shall be no unneces- comfort. sary holes or other openings where feet (2) The driving of the animals to the or legs of animals may be injured. shooting areas shall be done with a Overhead drop gates shall be suitably minimum of excitement and discom- covered on the bottom edge to prevent fort to the animals. Delivery of calm injury on contact with animals. Rough- animals to the shooting area is essen- ened or cleated cement shall be used as tial since accurate placement of the flooring in chutes leading to stunning bullet is difficult in case of nervous or areas to reduce falls of animals. injured animals. Among other things, Chutes, alleys, and stunning areas this requires that, in driving animals

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to the shooting areas, electrical equip- pending on age and sex of the animal. ment be used as little as possible and In the case of bulls, rams, and boars, with the lowest effective voltage. small bore firearms may be used pro- (3) Immediately after the firearm is vided they are able to produce imme- discharged and the projectile is deliv- diate unconsciousness of the animals. ered, the animal shall be in a state of Small bore firearms are usually effec- complete unconsciousness and remain tive for stunning other cattle, sheep, in this condition throughout shackling, swine, and goats, and calves, horses, sticking and bleeding. and mules. (b) Facilities and procedure—(1) Gen- eral requirements for shooting facilities; § 313.30 Electrical; stunning or slaugh- operator. (i) On discharge, acceptable tering with electric current. firearms dispatch free projectiles or The slaughtering of swine, sheep, bullets of varying sizes and diameters calves, cattle, and goats with the use of through the skull and into the brain. electric current and the handling in Unconsciousness is produced imme- connection therewith, in compliance diately by a combination of physical with the provisions contained in this brain destruction and changes in section, are hereby designated and ap- intracranial pressure. Caliber of fire- proved as humane methods of slaugh- arms shall be such that when properly tering and handling of such animals aimed and discharged, the projectile under the Act. produces immediate unconsciousness. (a) Administration of electric current, (ii) To assure uniform unconscious- required effect; handling. (1) The electric ness of the animal with every discharge current shall be administered so as to where small-bore firearms are em- produce, at a minimum, surgical anes- ployed, it is necessary to use one of the thesia, i.e., a state where the animal following type projectiles: Hollow feels no painful sensation. The animals pointed bullets; frangible iron plastic shall be either stunned or killed before composition bullets; or powdered iron they are shackled, hoisted, thrown, missiles. When powdered iron missiles cast, or cut. They shall be exposed to are used, the firearms shall be in close proximity with the skull of the animal the electric current in a way that will when fired. Firearms must be main- accomplish the desired result quickly tained in good repair. For purposes of and effectively, with a minimum of ex- protecting employees, inspectors and citement and discomfort. others, it is desirable that all firearms (2) The driving or conveying of the be equipped with safety devices to pre- animals to the place of application of vent injuries from accidental dis- electric current shall be done with a charge. Aiming and discharging of fire- minimum of excitement and discom- arms should be directed away from op- fort to the animals. Delivery of calm erating areas. animals to the place of application is (iii) The provisions contained in essential to ensure rapid and effective § 313.15(b)(1)(iii) with respect to the insensibility. Among other things, this stunning area also apply to the shoot- requires that, in driving animals to the ing area. place of application, electrical equip- (iv) The shooting operation is an ex- ment be used as little as possible and acting procedure and requires a well- with the lowest effective voltage. trained and experienced operator. He (3) The quality and location of the must be able to accurately direct the electrical shock shall be such as to projectile to produce immediate uncon- produce immediate insensibility to sciousness. He must use the correct pain in the exposed animal. caliber firearm, powder charge and (4) The stunned animal shall remain type of ammunition to produce the de- in a state of surgical anesthesia sired results. through shackling, sticking, and bleed- (2) Special requirements. Choice of fire- ing. arms and ammunition with respect to (b) Facilities and procedures; operator— caliber and choice of powder charge re- (1) General requirements for operator. It quired to produce immediate uncon- is necessary that the operator of elec- sciousness of the animal may vary de- tric current application equipment be

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skilled, attentive, and aware of his or she shall inform the establishment op- her responsibility. erator of the incident and request that (2) Special requirements for electric cur- the operator take the necessary steps rent application equipment. The ability to prevent a recurrence. If the estab- of electric current equipment to per- lishment operator fails to take such ac- form with maximum efficiency is de- tion or fails to promptly provide the pendent on its proper design and effi- inspector with satisfactory assurances cient mechanical operation. Pathways, that such action will be taken, the in- compartments, current applicators, spector shall follow the procedures and all other equipment used must be specified in paragraph (a), (b), or (c) of designed to properly accommodate the this section, as appropriate. species of animals being anesthetized. (a) If the cause of inhumane treat- Animals shall be free from pain-pro- ment is the result of facility defi- ducing restraining devices. Injury of animals must be prevented by the ciencies, disrepair, or equipment elimination of sharp projections or ex- breakdown, the inspector shall attach posed wheels or gears. There shall be a ‘‘U.S. Rejected’’ tag thereto. No no unnecessary holes, spaces or open- equipment, alleyway, pen or compart- ings where feet or legs of animals may ment so tagged shall be used until be injured. Impellers or other devices made acceptable to the inspector. The designed to mechanically move or tag shall not be removed by anyone drive animals or otherwise keep them other than an inspector. All livestock in motion or compartmentalized shall slaughtered prior to such tagging may be constructed of flexible or padded be dressed, processed, or prepared material. Power activated gates de- under inspection. signed for constant flow of animals (b) If the cause of inhumane treat- shall be so fabricated that they will ment is the result of establishment em- not cause injury. All equipment used to ployee actions in the handling or mov- apply and control the electrical curing of livestock, the inspector shall at- rent shall be maintained in good re- tach a ‘‘U.S. Rejected’’ tag to the al- pair, and all indicators, instruments, leyways leading to the stunning area. and measuring devices shall be avail- After the tagging of the alleyway, no able for inspection by Program inspec- more livestock shall be moved to the tors during the operation and at other stunning area until the inspector re- times. ceives satisfactory assurances from the (3) Electric current. Each animal shall establishment operator that there will be given a sufficient application of not be a recurrence. The tag shall not electric current to ensure surgical anesthesia throughout the bleeding oper- be removed by anyone other than an ation. Suitable timing, voltage and inspector. All livestock slaughtered current control devices shall be used to prior to the tagging may be dressed, ensure that each animal receives the processed, or prepared under inspec- necessary electrical charge to produce tion. immediate unconsciousness. The cur- (c) If the cause of inhumane treat- rent shall be applied so as to avoid the ment is the result of improper stun- production of hemorrhages or other tis- ning, the inspector shall attach a ‘‘U.S. sue changes which could interfere with Rejected’’ tag to the stunning area. inspection procedures. Stunning procedures shall not be resumed until the inspector receives sat- [44 FR 68813, Nov. 30, 1979, as amended at 50 FR 25202, June 18, 1985] isfactory assurances from the establishment operator that there will not § 313.50 Tagging of equipment, alley- be a recurrence. The tag shall not be ways, pens, or compartments to pre- removed by anyone other than an in- vent inhumane slaughter or han- spector. All livestock slaughtered prior dling in connection with slaughter. to such tagging may be dressed, proc- When an inspector observes an inci- essed, or prepared under inspection. dent of inhumane slaughter or handling in connection with slaughter, he/

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§ 313.90 [Reserved] are subjected to sufficient heating for sufficient time to effectively destroy PART 314—HANDLING AND DIS- the contents for human food purposes. POSAL OF CONDEMNED OR (2) The use of equipment such as OTHER INEDIBLE PRODUCTS AT crushers or hashers for pretanking preparation of condemned products in OFFICIAL ESTABLISHMENTS the inedible products department has been found to give inedible character Sec. and appearance to the material. Ac- 314.1 Disposition of condemned products at official establishments having tanking cordingly, if condemned products are facilities; sealing of tanks. so crushed or hashed, conveying sys- 314.2 Tanking and other facilities for ined- tems, rendering tanks, and other equip- ible products to be separate from edible ment used in the further handling of product facilities. crushed or hashed material need not be 314.3 Disposition of condemned products at locked or sealed during the tanking op- official establishments having no erations. If the rendering tanks or tanking facilities. other equipment contain condemned 314.4 Suppression of odors in preparing ined- material not so crushed or hashed, the ible products. 314.5 Inedible rendered fats prepared at offi- equipment shall be sealed as prescribed cial establishments. in paragraph (a)(1) of this section. If 314.6 Inedible fats from outside official es- the crushed or hashed material is not tablishments. rendered in the establishment where 314.7 Carcasses of livestock condemned on produced, it shall be denatured as pro- ante-mortem inspection not to pass vided for in § 314.3 before leaving such through edible product areas. establishment. 314.8 Dead animal carcasses. (b) The seals of tanks shall be broken 314.9 Specimens for educational, research, only by a Program employee and only and other nonfood purposes; permits for, required. after the contents of the tanks have 314.10 Livers condemned because of para- been treated as provided in paragraph sitic infestation and for other causes; (a) of this section. The rendered fat de- conditions for disposal for purposes other rived from condemned material shall than human food. be held until a Program employee shall 314.11 Handling of certain condemned prod- have had an opportunity to determine ucts for purposes other than human food. whether it conforms with the require- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, ments of this section. Samples shall be 2.55. taken by Program employees as often SOURCE: 35 FR 15575, Oct. 3, 1970, unless as is necessary to determine whether otherwise noted. the rendered fat is effectually denatured. § 314.1 Disposition of condemned prod- (c) Carcasses of animals condemned ucts at official establishments hav- under § 309.3 of this subchapter may be ing tanking facilities; sealing of disposed of as provided in § 314.3, in lieu tanks. of tanking, with the approval of the in- (a) Carcasses, parts of carcasses, and spector. other products condemned at official establishments having facilities for § 314.2 Tanking and other facilities for tanking shall, except as provided in inedible products to be separate paragraph (c) of this section or else- from edible product facilities. where in this part, be disposed of by All tanks and equipment used for tanking as follows: rendering, otherwise preparing, or stor- (1) The lower opening of the tank ing inedible products shall be in rooms shall first be sealed securely by a Pro- or compartments separate from those gram employee, except when perma- used for preparing or storing edible nently connected with a blow line; then products. There shall be no connection the condemned products shall be placed between rooms or compartments con- in the tank in his presence, after which taining inedible products and those the upper opening shall also be sealed containing edible products, except that securely by such employee, who shall there may be one connecting doorway then see that the contents of the tank between the slaughtering or viscera

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separating department and the tank equipped with condensers and other ap- charging room of the inedible products pliances which will acceptably suppress rendering department. Pipes and odors incident to such preparation. chutes installed in accordance with such arrangements as are permitted by § 314.5 Inedible rendered fats pre- part 308 of this subchapter, or as may pared at official establishments. be approved by the Administrator in Except as provided in § 325.11(b) of specific cases, may be used to convey this subchapter, rendered animal fat inedible and condemned material from derived from condemned or other ined- edible product departments to inedible ible materials at official establish- product departments. ments shall be denatured to effectually distinguish it from an edible product, § 314.3 Disposition of condemned products at official establishments hav- either with low grade offal during the ing no tanking facilities. rendering or by adding to, and mixing thoroughly with, such fat, denaturing (a) Carcasses, parts of carcasses, and oil, No. 2 fuel oil, or brucine dissolved other products condemned at an offi- in a mixture of alcohol and pine oil or cial establishment which has no facilities for tanking shall, except as pro- oil of rosemary, and may be shipped in vided in paragraph (b) of this section or commerce in accordance with § 325.11(c) elsewhere in this part, be destroyed in of this subchapter. the presence of an inspector by inciner- [35 FR 15575, Oct. 3, 1970, as amended at 53 FR ation, or denatured with crude carbolic 24679, June 30, 1988] acid, or cresylic disinfectant, or a formula consisting of one part FD&C No. § 314.6 Inedible fats from outside offi- 3 green coloring, 40 parts water, 40 cial establishments. parts liquid detergent, and 40 parts oil Except as provided in § 325.11(b) of of citronella or any other proprietary this subchapter, inedible fats from out- material approved by the Adminis- side the premises of any official estab- trator in specific cases. When such lishment shall not be received into an product is to be denatured, it shall be official establishment except into the freely slashed before the denaturing tank room provided for inedible prod- agent is applied, except that, in the ucts, and then only when they have case of dead animals that have not been denatured in accordance with been dressed, the denaturant may be § 314.5 and are marked in accordance applied by injection. The denaturant with § 316.15 of this subchapter, and must be deposited in all portions of the when their receipt into the tank room carcass or product to the extent nec- produces no insanitary condition on essary to preclude its use for food pur- the premises; nor shall such fats be re- poses. ceived in such volume as interferes (b) All carcasses and parts con- with prompt disposal of condemned or demned on account of anthrax, as iden- other inedible material produced at the tified in § 310.9(b) of this subchapter, at establishment. When received, they official establishments which are not shall not enter any room or compart- equipped with tanking facilities shall be disposed of by (1) complete inciner- ment used for edible products. ation, or (2) by thorough denaturing [35 FR 15575, Oct. 3, 1970, as amended at 53 FR with crude carbolic acid, or cresylic 24679, June 30, 1988] disinfectant, and then disposed of in accordance with the requirements of § 314.7 Carcasses of livestock con- the particular State or municipal au- demned on ante-mortem inspection thorities, who shall be notified imme- not to pass through edible product diately by the area supervisor. areas. Carcasses of livestock which have § 314.4 Suppression of odors in prepar- been condemned on ante-mortem in- ing inedible products. spection shall not be taken through Tanks, fertilizer driers, and other rooms or compartments in which an equipment used in the preparation of edible product is prepared, handled, or inedible product shall be properly stored.

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§ 314.8 Dead animal carcasses. tanking pursuant to the provisions of (a) With the exception of dead live- § 314.1 of this subchapter if condemned stock which have died en route and are at official establishments having facili- received with livestock for slaughter at ties for tanking; otherwise they shall an official establishment, no dead ani- be destroyed pursuant to the provisions mal or part of the carcass of any live- of § 314.3 of this subchapter. stock that died otherwise than by (b) Livers condemned because of slaughter may be brought on the prem- parasites other than hydatid cysts; and ises of an official establishment unless livers condemned because of advance permission therefore is ob- telangiectasis, angioma, ‘‘sawdust’’ tained from the circuit supervisor. condition, cirrhosis, carotenosis, or (b) Under no circumstances shall the other nonmalignant change, benign ab- carcasses of any animal which has died scesses, or contamination, when these otherwise than by slaughter, or any conditions are not associated with in- part thereof, be brought into any room fectious diseases in the carcasses, may or compartment in which any edible be shipped from an official establish- product is prepared, handled, or stored. ment only for purposes other than § 314.9 Specimens for educational, re- human food, and only if all tissue af- search, and other nonfood pur- fected with abscesses is removed and poses; permits for, required. destroyed within the establishment, (a) Specimens of condemned or other and all livers are processed and dena- inedible materials, including embryos tured, with any agent prescribed in and specimens of animal parasites, § 325.13(a)(1) or (2) or (5), and in accord- may be released for educational, re- ance with § 325.13(a)(6) of this sub- search, or other nonfood purposes chapter. This provision for movement under permit issued by the inspector in from an official establishment is made charge: Provided, That the person desir- solely under the Federal Meat Inspec- ing such specimens makes a written tion Act and is not intended to relieve application to the inspector in charge or modify any other applicable require- for such permit on Form MP–403–10 and ments under any other law regarding arranges with and receives permission the movement of such articles, for pur- from the official establishment to ob- poses other than use as human food. tain the specimens. Permits shall be is- (c) Livers condemned because of con- sued for a period not longer than 1 year. The permit may be revoked by ditions described in paragraph (b) of the inspector in charge if the speci- this section shall be in containers mens are not used as stated in the ap- plainly marked ‘‘inedible’’. plication, or if the collection or han- [41 FR 23701, June 11, 1976] dling of the specimens interferes with inspection or the maintenance of sani- § 314.11 Handling of certain con- tary conditions in the establishment. demned products for purposes (b) The specimens referred to in para- other than human food. graph (a) of this section shall be col- Condemned carcasses of animals af- lected and handled only at such time fected with one or more of the follow- and place and in such manner as not to ing conditions may be shipped from an interfere with the inspection or to official establishment only for pur- cause any objectionable condition and poses other than human food and only shall be identified as inedible when they leave the establishment. if permission therefor is obtained from the circuit supervisor: Anasarca, Ocu- [35 FR 15575, Oct. 3, 1970, as amended at 38 FR lar Squamous Cell Carcinoma (after re- 18665, July 13, 1973; 39 FR 36000, Oct. 7, 1974] moval of neoplastic tissue), emacia- § 314.10 Livers condemned because of tion, eosinophilic myositis, immatu- parasitic infestation and for other rity, nonseptic bruises and injuries, causes; conditions for disposal for and sarcosporidiosis. This provision purposes other than human food. also applies to unborn calves and to (a) Livers condemned on account of products such as paunches and udders hydatid cysts shall be disposed of by

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when they have not been handled as re- primal part, the requirements for seal- quired under this subchapter for prod- ing shall be at the discretion of the cir- ucts for human food purposes; pro- cuit supervisor. Such carcasses and vided, such articles have not been con- parts shall be cooked for a time suffi- demned for other pathological reasons. cient to render them effectually into Such permission will be granted only if lard or tallow, provided all parts of the all parts to be so used will be promptly products are heated to a temperature handled, freely slashed and adequately not lower than 170 °F. for a period of identified as required by § 325.13(a)(2) of not less than 30 minutes. this subchapter. The slashing, identi- (b) At establishments not equipped fication and packing of the product with closed rendering equipment for shall be accomplished in an inedible rendering carcasses and parts passed product area under the supervision of for cooking into lard and tallow, such an inspector. Facilities must be ade- carcasses or parts may be rendered in quate so that the carcasses or parts open kettles under the direct super- saved under these provisions are not vision of a Program employee. Such contaminated with pus, manure, septic, rendering shall be done during regular or toxic materials, or similar sub- hours of work and in compliance with stances. The operation must not result the requirements as to temperature in insanitary conditions within the es- and time specified in paragraph (a) of tablishment. this section. [35 FR 15575, Oct. 3, 1970, as amended at 36 FR [35 FR 15577, Oct. 3, 1970, as amended at 43 FR 11639, June 17, 1971; 36 FR 11903, June 23, 1971] 25420, June 13, 1978] PART 315—RENDERING OR OTHER § 315.2 Carcasses and parts passed for cooking; utilization for food pur- DISPOSAL OF CARCASSES AND poses after cooking. PARTS PASSED FOR COOKING Carcasses and parts passed for cook- Sec. ing may be used for the preparation of 315.1 Carcasses and parts passed for cook- meat food products, provided all such ing; rendering into lard or tallow. carcasses or parts are heated to a tem- 315.2 Carcasses and parts passed for cook- perature not lower than 170 °F. for a ing; utilization for food purposes after period of not less than 30 minutes ei- cooking. ther before being used in or during the 315.3 Disposal of products passed for cook- preparation of the finished product. ing if not handled according to this part. [37 FR 2661, Feb. 4, 1972] AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. § 315.3 Disposal of products passed for § 315.1 Carcasses and parts passed for cooking if not handled according to cooking; rendering into lard or tal- this part. low. Products passed for cooking if not Carcasses and parts passed for cook- handled and processed in accordance ing may be rendered into lard in ac- with the provisions of this part, shall cordance with § 319.702 of this sub- be disposed of in accordance with § 314.1 chapter or rendered into tallow, pro- or § 314.3 of this subchapter. vided such rendering is done in the fol- [35 FR 15577, Oct. 3, 1970. Redesignated at 37 lowing manner: FR 2661, Feb. 4, 1972] (a) When closed rendering equipment is used, the lower opening, except when PART 316—MARKING PRODUCTS permanently connected with a blowline, shall first be sealed securely AND THEIR CONTAINERS by a Program employee; then the carcasses or parts shall be placed in such Sec. 316.1 Authorization required to make de- equipment in his presence, after which vices bearing official marks. the upper opening shall be securely 316.2 Approval required for official marks. sealed by such employee. When the 316.3 Use of official marks prohibited except product passed for cooking in the tank under supervision of Program employee; does not consist of a carcass or whole removal of official marks, when required.

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316.4 Marking devices; to be furnished by of- cial mark, or any abbreviation or sim- ficial establishments; control of. ulation of any official mark, to or on 316.5 Branding ink; to be furnished by offi- any product, or container thereof, ex- cial establishments; approval by Pro- cept under the supervision of a Pro- gram; color. 316.6 Products not to be removed from offi- gram employee, or as authorized by cial establishments unless marked in ac- part 317 of this subchapter in connec- cordance with the regulations. tion with the manufacture of contain- 316.7 Marking devices not to be false or mis- ers. leading; style and size of lettering; ap- (b) No person shall fill, or cause to be proval required. filled, in whole or in part, with any 316.8 Unmarked inspected products; moved product, any container bearing or in- between official establishments; moved tended to bear any official mark, or in commerce. 316.9 Products to be marked with official any abbreviation or simulation of any marks. official mark, except under the super- 316.10 Marking of meat food products with vision of a Program employee. official inspection legend and ingredient (c) Product bearing any official mark statement. shall not be canned, cooked, cured, 316.11 Special markings for certain meat smoked, salted, packed, rendered, or food products. otherwise prepared by any person for 316.12 Marking of equine carcasses and commercial purposes unless: parts thereof. 316.13 Marking of outside containers. (1) Such preparation is performed at 316.14 Marking tank cars and tank trucks an official establishment; or used in transportation of edible products. (2) Such preparation is conducted 316.15 Marking outside containers of ined- under State or other governmental in- ible grease, etc. spection and the prepared product is 316.16 Custom prepared products to be marked to show that fact; or marked ‘‘Not for Sale.’’ (3) The official marks are removed, AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, defaced, or otherwise destroyed before 2.55. or during such preparation; or SOURCE: 35 FR 15577, Oct. 3, 1970, unless (4) The preparation of the product otherwise noted. consists solely of cutting up operations at any establishment exempted from § 316.1 Authorization required to make inspection under paragraph 301(c)(2) of devices bearing official marks. the Act or equal provisions of a law of No brand manufacturer, printer or a State or organized Territory or at other person shall cast, print, litho- any establishment in an unorganized graph, or otherwise make or cause to Territory exempted under paragraph be made any device containing any of- 23(b) of the Act. ficial mark or simulation thereof without prior written authority therefor § 316.4 Marking devices; to be fur- from the Administrator as provided for nished by official establishments; control of. in part 317 of this subchapter. (a) The operator of each official es- § 316.2 Approval required for official tablishment or official import inspec- marks. tion establishment shall furnish such No device containing any official ink brands, burning brands, and any mark shall be made or caused to be other device for marking products with made for use on any product until it official marks as the Administrator has been approved by the Adminis- may determine is necessary for mark- trator as provided for in part 317 of this ing products at such establishment. subchapter. The official inspection legend on such a device shall be as prescribed in part 312 § 316.3 Use of official marks prohibited of this subchapter. except under supervision of Pro- (b) All official devices for marking gram employee; removal of official products with the official inspection marks, when required. legend, or other official inspection (a) No person shall affix or place, or marks, including self-locking seals, cause to be affixed or placed, the offi- shall be used only under supervision of cial inspection legend or any other offi- a Program employee, and, when not in

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use for marking shall be kept locked in § 316.6 Products not to be removed properly equipped locks or compart- from official establishments unless ments, the keys of which shall not marked in accordance with the reg- leave the possession of a Program em- ulations. ployee, or the locker or compartment No person shall remove or cause to be shall be sealed with an official seal of removed from an official establishment the Department as prescribed in part any products which the regulations in 312 of this subchapter. this subchapter require to be marked [35 FR 15577, Oct. 3, 1970, as amended at 36 FR in any way unless they are clearly and 12004, June 24, 1971; 46 FR 38072, July 24, 1981] legibly marked in compliance with such regulations. § 316.5 Branding ink; to be furnished by official establishments; approval § 316.7 Marking devices not to be false by Program; color. or misleading; style and size of lettering; approval required. (a) The operator of each official establishment shall furnish all ink for No brand or other marking device marking products with the official shall be false or misleading. The letters marks at such establishment. Such ink and figures thereon shall be of such must be made with harmless ingredi- style and type as will make a clear and ents that are approved for the purpose legible impression. All markings to be by the Administrator. Samples of inks applied to products in an official estab- shall be submitted to the Program lab- lishment shall be approved prior to use oratory from time to time as may be by the Administrator as provided for in deemed necessary by the inspector in § 317.3 of this subchapter, except that charge. official markings prescribed by the (b) Only ink approved for the purpose Federal meat grading regulations (7 shall be used to apply ink brands bear- CFR 53.19) need not be submitted to the ing official marks to carcasses of cat- Administrator for approval. tle, sheep, swine, or goats and fresh § 316.8 Unmarked inspected products; meat cuts derived therefrom. Any ink moved between official establish- containing F.D. & C. Violet No. 1 shall ments; moved in commerce. not be considered an approved ink (a) Unmarked products which have within the meaning of this paragraph. been inspected and passed but do not (c) Green ink shall not be used to bear the official inspection legend may apply marks to carcasses of cattle, be transported in compliance with part sheep, swine, or goats or fresh meat 325 of this subchapter from one official cuts derived therefrom. establishment to another official es- (d) Except as provided in paragraphs tablishment, for further processing, in (b) and (c) of this section, branding ink a railroad car, truck, or other closed of any color, approved for the purpose container, if the railroad car, truck, or by the Administrator in specific cases, container is sealed with an official seal may be used to apply ink brands, bear- of the Department (as prescribed in ing official marks, to processed meat part 312 of this subchapter) bearing the cuts derived from cattle, sheep, swine, official inspection legend. or goats. (b) Products which have been in- (e) Only green ink approved for the spected and passed but do not bear the purpose shall be used to apply ink official inspection legend may be re- brands bearing official marks to car- moved from an official establishment casses and parts of carcasses and meat in closed containers bearing the offi- cuts derived from horses, mules, and cial inspection legend and all other in- other equines. formation required by this part and (f) Ink used must assure legibility part 317 of this subchapter: Provided, and permanence of the markings and That upon removal from such closed the color of ink shall provide accept- container the product may not be fur- able contrast with the color of the ther transported in commerce unless product to which it is applied. such removal is made under the super- [35 FR 15577, Oct. 3, 1970, as amended at 38 FR vision of a Program employee and such 9088, Apr. 10, 1973] product is reinspected by a Program

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employee and packed under his super- offered for sale or transportation, in vision in containers bearing the official commerce, except as provided in § 316.8. inspection legend and all other infor- [35 FR 15577, Oct. 3, 1970, as amended at 36 FR mation required by this part and part 23720, Dec. 14, 1971] 317 of this subchapter: And provided further, That unmarked product shall not § 316.10 Marking of meat food prod- be brought into an official establish- ucts with official inspection legend ment in an open container. and ingredient statement. (a) Inspected and passed sausages and § 316.9 Products to be marked with official marks. other products in casings or in link form, of the ordinary ‘‘ring’’ variety or (a) Each carcass which has been in- larger shall be marked with the official spected and passed in an official estab- inspection legend and list of ingredi- lishment shall be marked at the time ents in accordance with Part 317 of this of inspection with the official inspec- subchapter. The official marks re- tion legend containing the number of quired by this section shall be branded the official establishment. near each end of the sausage or similar (b) Except as provided otherwise in product prepared in casings when the § 316.8, each primal part of a carcass product is of a size larger than that and each liver, beef tongue, and beef customarily sold at retail intact. heart which has been inspected and (b) Inspected and passed sausage and passed shall be marked with the offi- other products, in casings or in link cial inspection legend containing the form, of the smaller varieties, shall number of the official establishment bear one or more official inspection before it leaves the establishment in legends and one or more lists of ingre- which it is first inspected and passed, dients in accordance with Part 317 of and each such inspected and passed this subchapter on each kilogram (2.205 product shall be marked with the offi- lbs.) of product, except where such cial inspection legend containing the products leave the official establish- number of the official establishment ment completely enclosed in properly where it was last prepared. Additional labeled immediate containers having a official marks of inspection may be ap- capacity of 5 kilograms (11.025 lbs.) or plied to products as desired to meet less and containing a single kind of local conditions. Primal parts are the product: That such products wholesale cuts of carcasses as cus- Provided, tomarily distributed to retailers. The in properly labeled closed containers round, flank, loin, rib, plate, brisket, exceeding 5 kilograms (11.025 lbs.) ca- chuck, and shank are primal parts of pacity, when shipped to another offi- beef carcasses. Veal, mutton, and goat cial establishment for further process- primal parts are the leg; flank, loin, ing or to a governmental agency, need rack, breast, and shoulder. The ham, only have the official inspection legend belly, loin, shoulder, and jowl are pork and list of ingredients shown twice primal parts. Equine primal parts are throughout the contents of the con- the round, flank, loin, rib, plate, bris- tainer. When such products are shipped ket, chuck, and shank. to another official establishment for (c) Beef livers shall be marked with further processing, the inspector in the official inspection legend contain- charge at the point of origin shall iden- ing the number of the official estab- tify the shipment to the inspector in lishment, at which the cattle involved charge at destination by means of were slaughtered, on the convex sur- Form MP 408–1. face of the thickest portion of the (c) The list of ingredients may be ap- organ. plied by stamping, printing, using (d) Inspected and passed parts of car- paper bands, tags, or tissue strips, or casses which are not marked with the other means approved by the Adminis- official inspection legend under this trator in specific cases. section shall not enter any official es- (d) All cured products shall be tablishment or be sold, transported, or marked with the list of ingredients in

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accordance with Part 317 of this sub- (c)(1) When product is placed in a cas- chapter. ing to which artificial coloring is thereafter applied, as permitted in Part [35 FR 15577, Oct. 3, 1970, as amended at 37 FR 16863, Aug. 22, 1972; 38 FR 4385, Feb. 14, 1973; 318 of this subchapter, the product 39 FR 36000, Oct. 7, 1974; 44 FR 67088, Nov. 23, shall be legibly and conspicuously 1979] marked by stamping or printing on the casing the words ‘‘artificially colored.’’ § 316.11 Special markings for certain (2) If a casing is removed from prod- meat food products. uct at an official establishment and (a) Meat food products prepared in there is evidence of artificial coloring casing or link form (whether or not on the surface of the product, the prod- thereafter subdivided), other than sau- uct from which the casing has been re- sage, which possess the characteristics moved shall be marked by stamping di- of or resemble sausage, shall bear on rectly thereon the words ‘‘artificially each link or piece the word ‘‘imita- colored.’’ tion’’ prominently displayed: Provided, (3) The casing containing product That the following need not be so need not be marked to show that it is marked if they bear on each link or colored if it is colored prior to its use piece the name of the product in ac- as a covering for the product, and the cordance with § 317.2 of this subchapter: coloring is of a kind and so applied as Such products as coppa, capocollo, not to be transferable to the product lachschinken, bacon, pork loins, pork and not to be misleading or deceptive shoulder butts, and similar cuts of in any respect. meat which are prepared without added (d) When an approved artificial substance other than curing materials smoke flavoring or an approved smoke or condiments; meat rolls, bockwurst, flavoring is added to the formula of and similar products which do not con- any meat food product as permitted in tain cereal or vegetables; headcheese, part 318 of this subchapter, the product souse, sulze, scrapple, blood pudding, shall be legibly and conspicuously and liver pudding; and other products marked with the words ‘‘Artificial such as loaves, chili con carne, and Smoke Flavoring Added’’ or ‘‘Smoke meat and cheese products when pre- Flavoring Added,’’ whichever may be pared with sufficient cheese to give applicable. definite characteristics to the finished (e) Subject to the provisions in para- products: And provided further, That graph (a) of this section, in the case of imitation sausage packed in properly sausage of the smaller varieties, the labeled containers having a capacity of markings prescribed in this section 3 pounds or less and of a kind usually may be limited to links bearing the of- sold at retail intact, need not bear the ficial inspection legend, and such word ‘‘imitation’’ on each link or piece markings shall not be required if the if no other marking or labeling is ap- sausages are packed in properly labeled plied directly to the product. containers having a capacity of 3 (b) When cereal, vegetable starch, pounds or less and of a kind usually starchy vegetable flour, soy flour, soy sold at retail intact. Further, all mark- protein concentrate, isolated soy pro- ings otherwise required by this section tein, dried milk, nonfat dry milk, or (except those required by paragraph (a) calcium reduced dried skim milk is of this section) may be omitted from added to sausage in casing or in link the casings of sausage and other meat form within the limits prescribed in food products when these products are part 319 of this subchapter, the prod- to be processed in sealed metal con- ucts shall be marked with the name of tainers properly labeled in accordance each added ingredient, as for example with the requirements in part 317 of ‘‘cereal added,’’ ‘‘potato flour added,’’ this subchapter. ‘‘cereal and potato flour added,’’ ‘‘soy (f) When an approved antioxidant is flour added,’’ ‘‘isolated soy protein added to any meat food product as per- added,’’ ‘‘nonfat dry milk added,’’ ‘‘cal- mitted in parts 318 and 319 of this sub- cium reduced dried skim milk added,’’ chapter, the products shall be legibly or ‘‘cereal and nonfat dry milk added,’’ and conspicuously marked in an ap- as the case may be. proved manner identifying the specific

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antioxidant used by its common name crinkled paper bags, for properly or approved abbreviation and the pur- marked products, which are used solely pose for which it is added, such as, to protect the product against soiling ‘‘BHA, BHT, and Propylgallate added or excessive drying during transpor- to help protect flavor.’’ tation or storage, need not bear the of- (g) Sausage of the dry varieties treat- ficial inspection legend. ed with potassium sorbate or (c) The outside containers of prod- propylparaben (propyl p-hydroxyben- ucts for export shall be marked in com- zoate) as permitted by Part 318 of this pliance with part 322 of this subchapter subchapter shall be marked as pre- as well as this part. scribed in § 317.8(b)(28) of this sub- (d) Slack barrels used as outside con- chapter). tainers of products shall have a cloth or paper top covering bearing the offi- § 316.12 Marking of equine carcasses cial inspection legend containing the and parts thereof. official establishment number. At the (a) All inspected and passed equine time of removal of the covering, the of- carcasses and parts thereof prepared at ficial inspection legend shall be de- any establishment shall be conspicu- stroyed. ously marked at the time of inspection (e) The outside containers of any with the official inspection legend as product which has been inspected and prescribed in § 312.3 of this subchapter passed for cooking, pork which has and with other information prescribed been refrigerated as provided in for marking products in this part. § 318.10(c) of this subchapter, and beef (b) All equine carcasses and meat and which has been inspected and passed other parts thereof shall be marked to for refrigeration shall bear the mark- show the kinds of animals from which ings and tag prescribed in § 325.7(b) of they were derived, before the products this subchapter. are sold, transported, offered for sale or (f) The outside containers of glands transportation, or received for trans- and organs which are not used for portation in commerce. human food purposes, such as those described in § 325.19 of this subchapter, § 316.13 Marking of outside containers. shall be plainly marked with the (a) Except as otherwise provided in phrase ‘‘For pharmaceutical purposes,’’ part 325 of this subchapter, when any ‘‘For organotherapeutic purposes’’ or inspected and passed product for do- ‘‘For technical purposes,’’ as appro- mestic commerce is moved from an of- priate, with no reference to inspection, ficial establishment, the outside con- and need not bear other markings oth- tainer shall bear an official inspection erwise required under the regulations legend as prescribed in part 312 of this in this subchapter. subchapter. (g) Stencils, box dies, labels, and (b) When any product prepared in an brands may be used on shipping con- official establishment for domestic tainers of properly labeled products commerce has been inspected and and on such immediate containers, of passed and is enclosed in a cloth or properly marked products, as tierces, other wrapping, such wrapping shall barrels, drums, boxes, crates, and bear the official inspection legend and large-size fiber-board containers, with- official establishment number applied out approval as provided for in § 317.3 of by the approved 21⁄2-inch rubber brand this subchapter: Provided, That the in the form prescribed in part 312 of stencils, box dies, labels, and brands this subchapter: Provided, That the are not false or misleading and are ap- rubber brand may be omitted if the of- proved by the inspector in charge. The ficial inspection legend and official es- official inspection legend for use with tablishment number on the product it- such markings shall be approved by the self are clearly legible through the Administrator as provided for in part wrapping or the wrapping is labeled in 317 of this subchapter. accordance with part 317 of this sub- (h) The outside containers of livers chapter: Provided further, That plain prepared as described in § 314.10(b), unprinted wrappings, such as shall be marked as prescribed in stockinettes, cheesecloth, paper, and § 314.10(c) of this subchapter.

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(i) The outside containers of any graph (a) of this section and part 314 of equine product shall be marked to this subchapter. show the kinds of animals from which derived, when the products are sold, § 316.16 Custom prepared products to transported, offered for sale or trans- be marked ‘‘Not for Sale.’’ ported, or received for transportation Carcasses and parts therefrom that in commerce. are prepared on a custom basis under § 303.1(a)(2) of this subchapter shall be [35 FR 15577, Oct. 3, 1970, as amended at 43 FR 29268, July 7, 1978] marked at the time of preparation with the term ‘‘Not for Sale’’ in letters at § 316.14 Marking tank cars and tank least three-eighths inch in height, ex- trucks used in transportation of ed- cept that such products need not be so ible products. marked if in immediate containers Each tank car and each tank truck properly labeled in accordance with the carrying inspected and passed product regulations in § 317.16 of this sub- from an official establishment shall chapter. Ink used for marking such bear a label containing the name of the products must comply with the re- product in accordance with § 317.2 of quirements of § 316.5. this subchapter, the official inspection [35 FR 15577, Oct. 3, 1970, as amended at 38 FR legend containing the number of the of- 29214, Oct. 23, 1973] ficial establishment and the words ‘‘date of loading,’’ followed by a suit- PART 317—LABELING, MARKING able space in which the date the tank DEVICES, AND CONTAINERS car or tank truck is loaded shall be inserted. The label shall be located con- Subpart A—General spicuously and shall be printed on material of such character and so affixed Sec. as to preclude detachment or efface- 317.1 Labels required; supervision by Pro- ment upon exposure to the weather. gram employee. Before the car or truck is removed 317.2 Labels: definition; required features. from the place where it is unloaded, 317.3 Approval of abbreviations of marks of the carrier shall remove or obliterate inspection; preparation of marking devices bearing inspection legend without such label. advance approval prohibited; exception. [53 FR 28634, July 29, 1988] 317.4 Labeling approval. 317.5 Generically approved labeling. § 316.15 Marking outside containers of 317.6 Approved labels to be used only on inedible grease, etc. products to which they are applicable. 317.7 Products for foreign commerce; print- (a) Outside containers of inedible ing labels in foreign language permis- grease, inedible tallow, or other ined- sible; other deviations. ible animal fat, or mixture of any such 317.8 False or misleading labeling or prac- articles, resulting from operations at tices generally; specific prohibitions and any official establishment shall be requirements for labels and containers. marked conspicuously with the word 317.9 Labeling of equine products. ‘‘inedible’’ prior to removal from the 317.10 Reuse of official inspection marks; point of filling. Containers, such as reuse of containers bearing official marks, labels, etc. tierces, barrels, and half barrels shall 317.11 Labeling, filling of containers, han- have both ends painted white with du- dling of labeled products to be only in rable paint, if necessary, to provide a compliance with regulations. contrasting background, and the word 317.12 Relabeling products; requirements. ‘‘inedible’’ shall be marked thereon in 317.13 Storage and distribution of labels and letters not less than 2 inches high, containers bearing official marks. while on tank cars and tank trucks the 317.14–317.15 [Reserved] letters shall be not less than 4 inches 317.16 Labeling and containers of custom high. prepared products. 317.17 Interpretation and statement of la- (b) Inspected rendered animal fat beling policy for cured products; special which is intended not to be used for labeling requirements concerning nitrate human food may also be marked ‘‘ined- and nitrite. ible’’ if handled as provided in para- 317.18 Quantity of contents labeling.

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317.19 Definitions and procedures for deter- Subpart A—General mining net weight compliance. 317.20 Scale requirements for accurate § 317.1 Labels required; supervision by weights, repairs, adjustments, and re- Program employee. placement after inspection. 317.21 Scales: testing of. (a) When, in an official establish- 317.22 Handling of failed product. ment, any inspected and passed prod- 317.23 [Reserved] uct is placed in any receptacle or cov- 317.24 Packaging materials. ering constituting an immediate container, there shall be affixed to such Subpart B—Nutrition Labeling container a label as described in § 317.2 except that the following do not have 317.300 Nutrition labeling of meat or meat to bear such a label. food products. (1) Wrappings of dressed carcasses 317.301 [Reserved] and primal parts in an unprocessed 317.302 Location of nutrition information. state, bearing the official inspection 317.303–317.307 [Reserved] legend, if such wrappings are intended 317.308 Labeling of meat or meat food prod- solely to protect the product against ucts with number of servings. soiling or excessive drying during 317.309 Nutrition label content. transportation or storage, and the 317.310–317.311 [Reserved] wrappings bear no information except 317.312 Reference amounts customarily consumed per eating occasion. company brand names, trade marks, or 317.313 Nutrient content claims; general code numbers which do not include any principles. information required by § 317.2; 317.314–317.342 [Reserved] (2) Uncolored transparent coverings, 317.343 Significant participation for vol- such as cellophane, which bear no writ- untary nutrition labeling. ten, printed, or graphic matter and 317.344 Identification of major cuts of meat which enclose any unpackaged or products. packaged product bearing all markings 317.345 Guidelines for voluntary nutrition required by part 316 of this subchapter labeling of single-ingredient, raw prod- which are clearly legible through such ucts. coverings; 317.346–317.353 [Reserved] (3) Animal and transparent artificial 317.354 Nutrient content claims for ‘‘good casings bearing only the markings re- source,’’ ‘‘high,’’ and ‘‘more’’. quired by part 316 of this subchapter; 317.355 [Reserved] (4) Stockinettes used as ‘‘operative 317.356 Nutrient content claims for ‘‘light’’ devices’’, such as those applied to cured or ‘‘lite’’. 317.357–317.359 [Reserved] meats in preparation for smoking, 317.360 Nutrient content claims for calorie whether or not such stockinettes are content. removed following completion of the 317.361 Nutrient content claims for the so- operations for which they were applied; dium content. (5) Containers such as boil-in bags, 317.362 Nutrient content claims for fat, trays of frozen dinners, and pie pans fatty acids, and cholesterol content. which bear no information except com- 317.363 Nutrient content claims for pany brand names, trademarks, code ‘‘healthy’’. numbers, directions for preparation 317.364–317.368 [Reserved] and serving suggestions, and which are 317.369 Labeling applications for nutrient enclosed in a consumer size container content claims. that bears a label as described in § 317.2; 317.370–317.379 [Reserved] (6) Containers of products passed for 317.380 Label statements relating to useful- cooking or refrigeration and moved ness in reducing or maintaining body from an official establishment under weight. § 311.1 of this subchapter. 317.381–317.399 [Reserved] (b) Folders and similar coverings 317.400 Exemption from nutrition labeling. made of paper or similar materials, AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, whether or not they completely enclose 2.53. the product and which bear any writ- SOURCE: 35 FR 15580, Oct. 3, 1970, unless ten, printed, or graphic matter, shall otherwise noted. bear all features required on a label for an immediate container.

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(c) No covering or other container name of the food specified in the stand- which bears or is to bear a label shall ard, and in the case of any other prod- be filled, in whole or in part, except uct shall be the common or usual name with product which has been inspected of the food, if any there be, and if there and passed in compliance with the reg- is none, a truthful descriptive designa- ulations in this subchapter, which is tion, as prescribed in paragraph (e) of not adulterated and which is strictly in this section; accordance with the statements on the (2) If the product is fabricated from label. No such container shall be filled, two or more ingredients, the word ‘‘in- in whole or in part, and no label shall gredients’’ followed by a list of the in- be affixed thereto, except under super- gredients as prescribed in paragraph (f) vision of a Program employee. of this section; (3) The name and place of business of § 317.2 Labels: definition; required fea- the manufacturer, packer, or distribu- tures. tor for whom the product is prepared, (a) A label within the meaning of this as prescribed in paragraph (g) of this part shall mean a display of any print- section; ing, lithographing, embossing, stickers, (4) An accurate statement of the net seals, or other written, printed, or quantity of contents, as prescribed in graphic matter upon the immediate paragraph (h) of this section; container (not including package lin- (5) An official inspection legend and, ers) of any product. except as otherwise provided in para- (b) Any word, statement, or other in- graph (i) of this section, the number of formation required by this part to ap- the official establishment, in the form pear on the label must be prominently required by part 312 of this subchapter; placed thereon with such conspicuous- (6) Any other information required ness (as compared with other words, by the regulations in this part or part statements, designs, or devices, in the 319 of this subchapter. labeling) and in such terms as to (d) The principal display panel shall render it likely to be read and under- be the part of a label that is most like- stood by the ordinary individual under ly to be displayed, presented, shown, or customary conditions of purchase and examined under customary conditions use. In order to meet this requirement, of display for sale. Where packages such information must appear on the bear alternate principal display panels, principal display panel except as other- information required to be placed on wise permitted in this part. Except as the principal display panel shall be du- provided in § 317.7, all words, state- plicated on each principal display ments, and other information required panel. The principal display panel shall by or under authority of the Act to ap- be large enough to accommodate all pear on the label or labeling shall ap- the mandatory label information re- pear thereon in the English language: quired to be placed thereon by this part Provided, however, That in the case of and part 319 of this subchapter with products distributed solely in Puerto clarity and conspicuousness and with- Rico, Spanish may be substituted for out obscuring of such information by English for all printed matter except designs or vignettes or crowding. In de- the USDA inspection legend. termining the area of the principal dis- (c) Labels of all products shall show play panel, exclude tops, bottoms, the following information on the prin- flanges at tops and bottoms of cans, cipal display panel (except as otherwise and shoulders and necks of bottles or permitted in this part), in accordance jars. The principal display panel shall with the requirements of this part or, be: if applicable, part 319 of this sub- (1) In the case of a rectangular pack- chapter: age, one entire side, the area of which (1) The name of the product, which in is at least the product of the height the case of a product which purports to times the width of that side. be or is represented as a product for (2) In the case of a cylindrical or which a definition and standard of nearly cylindrical container: identity or composition is prescribed in (i) An area that is 40 percent of the part 319 of this subchapter, shall be the product of the height of the container

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times the circumference of the con- celery, whose primary function in food tainer, or is seasoning rather than nutritional (ii) A panel, the width of which is and from which no portion of any vola- one-third of the circumference and the tile oil or other flavoring principle has height of which is as high as the con- been removed. Spices include the spices tainer: Provided, however, That if there listed in 21 CFR 182.10, and 184. is immediately to the right or left of (B) The term ‘‘natural flavor,’’ ‘‘nat- such principal display panel, a panel ural flavoring,’’ ‘‘flavor’’ or ‘‘flavor- which has a width not greater than 20 ing’’ means the essential oil, oleoresin, percent of the circumference and a essence or extractive, protein hydroly- height as high as the container, and sate, distillate, or any product or which is reserved for information pre- roasting, heating or enzymolysis, scribed in paragraphs (c) (2), (3), and which contains the flavoring constitu- (5), such panel shall be known as the ents derived from a spice, fruit or fruit ‘‘20 percent panel’’ and such informa- juice, vegetable or vegetable juice, edition may be shown on that panel in ble yeast, herb, bark, bud, root, leaf or lieu of showing it on the principal display panel. any other edible portion of a plant, (3) In the case of a container of any meat, seafood, poultry, eggs, dairy other shape, 40 percent of the total sur- products, or fermentation products face of the container. thereof, whose primary function in (e) Any descriptive designation used food is flavoring rather than nutri- as a product name for a product which tional. Natural flavors include the nat- has no common or usual name shall ural essence or extractives obtained clearly and completely identify the from plants listed in 21 CFR 182.10, product. Product which has been pre- 182.20, 182.40, 182.50 and 184, and the pared by salting, smoking, drying, substances listed in 21 CFR 172.510. The cooking, chopping, or otherwise shall term natural flavor, natural flavoring, be so described on the label unless the flavor or flavoring may also be used to name of the product implies, or the designate spices, powered onion, pow- manner of packaging shows that the dered garlic, and powdered celery. product was subjected to such prepara- (ii) The term ‘‘corn syrup’’ may be tion. The unqualified terms ‘‘meat,’’ used to designate either corn syrup or ‘‘meat byproduct,’’ ‘‘meat food prod- corn syrup solids. uct,’’ and terms common to the meat (iii) The term ‘‘animal and vegetable industry but not common to consumers fats’’ or ‘‘vegetable and animal fats’’ such as ‘‘picnic,’’ ‘‘butt,’’ ‘‘cala,’’ may be used to designate the ingredi- ‘‘square,’’ ‘‘loaf,’’ ‘‘spread,’’ ‘‘delight,’’ ents of mixtures of such edible fats in ‘‘roll,’’ ‘‘plate,’’ ‘‘luncheon,’’ and product designated ‘‘compound’’ or ‘‘daisy’’ shall not be used as names of a ‘‘shortening.’’ ‘‘Animal fats’’ as used product unless accompanied with terms herein means fat derived from in- descriptive of the product or with a list spected and passed cattle, sheep, swine, of ingredients, as deemed necessary in or goats. any specific case by the Administrator in order to assure that the label will (iv) When a product is coated with not be false or misleading. pork fat, gelatin, or other approved (f)(1) The list of ingredients shall substance and a specific declaration of show the common or usual names of such coating appears contiguous to the the ingredients arranged in the de- name of the product, the ingredient scending order of predominance, except statement need not make reference to as otherwise provided in this para- the ingredients of such coating. graph. (v) When two meat ingredients com- (i) The terms spice, natural flavor, prise at least 70 percent of the meat natural flavoring, flavor and flavoring and meat byproduct ingredients of a may be used in the following manner: formula and when neither of the two (A) The term ‘‘spice’’ means any aro- meat ingredients is less than 30 percent matic vegetable substance in the by weight of the total meat and meat whole, broken, or ground form, with byproducts used, such meat ingredients the exceptions of onions, garlic and may be interchanged in the formula

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without a change being made in the in- case of a cylindrical or nearly cylin- gredients statement on labeling mate- drical container. rials: Provided, That the word ‘‘and’’ in (4) The ingredients statement may be lieu of a comma shall be shown be- placed on the information panel, ex- tween the declaration of such meat in- cept as otherwise permitted in this gredients in the statement of ingredi- subchapter. ents. (g)(1) The name or trade name of the (vi)(A) Product ingredients which are person that prepared the product may present in individual amounts of 2 per- appear as the name of the manufac- cent or less by weight may be listed in turer or packer without qualification the ingredients statement in other on the label. Otherwise the name of the than descending order of predomi- distributor of the product shall be nance: Provided, That such ingredients shown with a phrase such as ‘‘Prepared are listed by their common or usual for * * *’’. The place of business of the names at the end of the ingredients manufacturer, packer, or distributor statement and preceded by a quantify- shall be shown on the label by city, ing statement, such as ‘‘Contains State, and postal ZIP code when such lllll lllll percent of ,’’ ‘‘Less business is listed in a telephone or city lllll lllll than percent of .’’ directory, and if not listed in such di- The percentage of the ingredient(s) rectory, then the place of business shall be filled in with a threshold level shall be shown by street address, city, of 2 percent, 1.5 percent, 1.0 percent, or State, and postal ZIP code. 0.5 percent, as appropriate. No ingredi- (2) The name and place of business of ent to which the quantifying statement the manufacturer, packer, or distribu- applies may be present in an amount tor may be shown: greater than the stated threshold. Such a quantifying statement may also be (i) On the principal display panel, or utilized when an ingredients statement (ii) On the 20 percent panel adjacent contains a listing of ingredients by in- to the principal display panel and re- dividual components. Each component served for required information, in the listing may utilize the required quan- case of a cylindrical or nearly cylin- tifying statement at the end of each drical container, or component ingredients listing. (iii) On the front riser panel of frozen (B) Such ingredients may be adjusted food cartons, or in the product formulation without a (iv) On the information panel. change being made in the ingredients (h)(1) The statement of net quantity statement on the labeling, provided of contents shall appear on the prin- that the adjusted amount complies cipal display panel of all containers to with § 318.7(c)(4) and part 319 of this be sold at retail intact, in conspicuous subchapter, and does not exceed the and easily legible boldface print or amount shown in the quantifying type in distinct contrast to other mat- statement. Any such adjustments to ter on the container, and shall be de- the formulation shall be provided to clared in accordance with the provi- the inspector-in-charge. sions of this paragraph. (2) On containers of frozen dinners, (2) The statement as it is shown on a entrees, pizzas, and similar consumer label shall not be false or misleading packaged products in cartons the in- and shall express an accurate state- gredient statement may be placed on ment of the quantity of contents of the the front riser panel: Provided, That container. Reasonable variations the words ‘‘see ingredients’’ followed caused by loss or gain of moisture dur- immediately by an arrow is placed on ing the course of good distribution the principal display panel imme- practices or by unavoidable deviations diately above the location of such in good manufacturing practices will statement without intervening print or be recognized. Variations from stated designs. quantity of contents shall be as pro- (3) The ingredient statement may be vided in § 317.19. The statement shall placed on the 20 percent panel adjacent not include any term qualifying a unit to the principal display panel and re- of weight, measure, or count such as served for required information, in the ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant

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quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ section permits certain exceptions or words of similar importance. from the provisions of this paragraph (3) The statement shall be placed on for margarine packages, random the principal display panel within the weight consumer size packages, and bottom 30 percent of the area of the packages of less than 1⁄2 ounce net panel in lines generally parallel to the weight. Pargraph (h)(12) of this section base: Provided, That on packages hav- permits certain exceptions from the ing a principal display panel of 5 square provision of this paragraph for multi- inches or less, the requirement for unit packages. placement within the bottom 30 per- (6) The statement shall be in letters cent of the area of the label panel shall and numerals in type size established not apply when the statement meets in relationship to the area of the prin- the other requirements of this para- cipal display panel of the package and graph (h). In any case, the statement shall be uniform of all packages of sub- may appear in more than one line. The stantially the same size by complying terms ‘‘net weight’’ or ‘‘net wt.’’ shall with the following type specifications: be used when stating the net quantity (i) Not less than one-sixteenth inch of contents in terms of weight, and the in height on packages, the principal term ‘‘net contents’’ or ‘‘content’’ display panel of which has an area of 5 when stating the net quantity of con- square inches or less; tents in terms of fluid measure. (ii) Not less than one-eighth inch in (4) Except as provided in § 317.7, the height on packages, the principal dis- statement shall be expressed in terms play panel of which has an area of more of avoirdupois weight or liquid meas- than 5 but not more than 25 square ure. Where no general consumer usage inches; to the contrary exists, the statement (iii) Not less than three-sixteenths shall be in terms of liquid measure, if inch in height on packages, the prin- the product is liquid, or in terms of cipal display panel of which has an weight if the product is solid, semisolid area of more than 25 but not more than viscous or a mixture of solid and liquid. 100 square inches; For example, a declaration of 3⁄4-pound (iv) Not less than one-quarter inch in avoirdupois weight shall be expressed height on packages, the principal dis- as ‘‘Net Wt. 12 oz.’’ except as provided play panel of which has an area of more for in paragraph (h)(5) of this section than 100 but not more than 400 square for random weight packages; a declara- inches. tion of 11⁄2 pounds avoirdupois weight (v) Not less than one-half inch in shall be expressed as ‘‘Net Wt. 24 oz. (1 height on packages, the principal dis- lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 lb.),’’ or play panel of which has an area of more ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ than 400 square inches. (5) On packages containing 1 pound (7) The ratio of height to width of let- or 1 pint and less than 4 pounds or 1 ters and numerals shall not exceed a gallon, the statement shall be ex- differential of 3 units to 1 unit (no pressed as a dual declaration both in more than 3 times as high as it is ounces and (immediately thereafter in wide). Heights pertain to upper case or parentheses) in pounds, with any re- capital letters. When upper and lower mainder in terms of ounces or common case or all lower case letters are used, or decimal fraction of the pound, or in it is the lower case letter ‘‘o’’ or its the case of liquid measure, in the larg- equivalent that shall meet the mini- est whole units with any remainder in mum standards. When fractions are terms of fluid ounces or common or used, each component numeral shall decimal fractions of the pint or quart, meet one-half the height standards. except that on random weight pack- (8) The statement shall appear as a ages the statement shall be expressed distinct item on the principal display in terms of pounds and decimal frac- panel and shall be separated by a space tions of the pound, for packages over 1 at least equal to the height of the let- pound, and for packages which do not tering used in the statement from exceed 1 pound the statement may be other printed label information appear- in decimal fractions of the pound in ing above or below the statement and lieu of ounces. Paragraph (h)(9) of this by a space at least equal to twice the

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width of the letter ‘‘N’’ of the style of (iii) Individually wrapped and labeled type used in the quantity of contents packages of less than 1⁄2 ounce net statement from other printed label in- weight bearing labels declaring net formation appearing to the left or right weight, price per pound, and total of the statement. It shall not include price, shall be exempt from the type any term qualifying a unit of weight, size, dual declaration, and placement measure, or count such as, ‘‘jumbo requirements of this paragraph, if an quart,’’ ‘‘full gallon,’’ ‘‘giant quart,’’ accurate statement of net weight is ‘‘when packed,’’ ‘‘Minimum’’ or words shown conspicuously on the principal of similar import. display panel of the package. (9) The following exemptions from (iv) Margarine in 1 pound rectangular the requirements contained in this packages (except packages containing paragraph (h) are hereby established: whipped or soft margarine or packages (i) Individually wrapped, random that contain more than four sticks) is exempt from the requirements of para- weight consumer size packages shipped graphs (h) (3) and (5) of this section rein bulk containers (as specified in para- garding the placement of the state- graph (h)(11) of this section) and meat ment of the net quantity of contents products that are subject to shrinkage within the bottom 30 percent of the through moisture loss during good dis- principal display panel and that the tribution practices and are designated statement be expressed both in ounces as gray area type of products as defined and in pounds, if the statement appears under § 317.19 need not bear a net as ‘‘1 pound’’ or ‘‘one pound’’ in a con- weight statement when shipped from spicuous manner on the principal dis- an official establishment, provided play panel. that a net weight shipping statement (v) Sliced shingle packed bacon in which meets the requirements of para- rectangular packages is exempt from graph (h)(2) of this section is applied to the requirements of paragraphs (h)(3) their shipping container prior to ship- and (h)(5) of this section regarding the ping it from the official establishment. placement of the statement of the net Net weight statements so applied to quantity of contents within the bottom the shipping container are exempt from 30 percent of the principal display the type size, dual declaration, and panel, and that the statement be ex- placement requirements of this para- pressed both in ounces and in pounds, if graph, if an accurate statement of net the statement appears in a conspicuous weight is shown conspicuously on the manner on the principal display panel. principal display panel of the shipping (10) Labels for containers which bear container. The net weight also shall be any representation as to the number of applied directly to random weight servings contained therein shall bear, consumer size packages prior to retail contiguous to such representation, and display and sale. The net weight state- in the same size type as is used for ment on random weight consumer size such representation, a statement of the packages for retail sale shall be exempt net quantity of each such serving. from the type size, dual declaration, (11) As used in this section, a ‘‘ran- and placement requirements of this dom weight consumer size package’’ is paragraph, if an accurate statement of one which is one of a lot, shipment or net weight is shown conspicuously on delivery of packages of the same prod- the principal display panel of the pack- uct with varying weights and with no age. fixed weight pattern. (ii) Individually wrapped and labeled (12) On a multiunit retail package, a packages of less than 1⁄2 ounce net statement of the net quantity of con- weight and random weight consumer tents shall appear on the outside of the size packages shall be exempt from the package and shall include the number requirements of this paragraph is they of individual units, the quantity of are in a shipping container and the each individual unit, and in paren- statement of net quantity of contents theses, the total net quantity of con- on the shipping container meets the re- tents of the multiunit package in quirements of paragraph (h)(2) of this terms of avoirdupois or fluid ounces, section; except that such declaration of total

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quantity need not be followed by an ad- (1) A label for product which is an ditional parenthetical declaration in imitation of another food shall bear terms of the largest whole units and the word ‘‘imitation’’ immediately pre- subdivisions thereof, as required by ceding the name of the food imitated paragraph (h)(5) of this section. For the and in the same size and style of letter- purposes of this section, ‘‘multiunit re- ing as in that name and immediately tail package’’ means a package con- thereafter the word ‘‘ingredients:’’ and taining two or more individually the names of the ingredients arranged packaged units of the identical com- in the order of their predominance. modity and in the same quantity, with (2) If a product purports to be or is the individual packages intended to be represented for any special dietary use sold as part of the multiunit retail by man, its label shall bear a state- package but capable of being individ- ment concerning its vitamin, mineral, ually sold in full compliance with all and other dietary properties upon requirements of the regulations in this which the claim for such use is based in part. Open multiunit retail packages whole or in part and shall be in con- that do not obscure the number of formity with regulations (21 CFR part units and the labeling thereon are not 125) established pursuant to sections subject to this paragraph if the label- 403, and 701 of the Federal Food, Drug, ing of each individual unit complies and Cosmetic Act (21 U.S.C. 343, 371). with the requirements of paragraphs (3) When an artificial smoke flavor- (h) (2), (3), (6), and (8) of this section. ing or an smoke flavoring is added as (i) The official establishment number an ingredient in the formula of a meat of the official establishment in which food product, as permitted in part 318 the product was processed under in- of this subchapter, there shall appear spection shall be placed as follows: on the label, in prominent letters and (1) Within the official inspection leg- contiguous to the name of the product, a statement such as ‘‘Artificial Smoke end in the form required by part 312 of Flavoring Added’’ or ‘‘Smoke Flavor- this subchapter; or ing Added,’’ as may be applicable, and (2) Outside the official inspection leg- the ingredient statement shall identify end elsewhere on the exterior of the any artificial smoke flavoring or container or its labeling, e.g., the lid of smoke flavoring so added as an ingredi- a can, if shown in a prominent and leg- ent in the formula of the meat food ible manner in a size sufficient to in- product. sure easy visibility and recognition and (4) When any other artificial flavor- accompanied by the prefix ‘‘EST’’; or ing is permitted under part 318 of this (3) Off the exterior of the container, subchapter to be added to a product, e.g., on a metal clip used to close cas- the ingredient statement shall identify ings or bags, or on the back of a paper it as ‘‘Artificial Flavoring.’’ label of a canned product, or on other (5) When artificial coloring is added packaging or labeling material in the to edible fats as permitted under part container, e.g., on aluminum pans and 318 of this subchapter such substance trays placed within containers, when a shall be declared on the label in a statement of its location is printed prominent manner and contiguous to contiguous to the official inspection the name of the product by the words legend, such as ‘‘EST. No. on Metal ‘‘Artificially colored’’ or ‘‘Artificial Clip’’ or ‘‘Est. No. on Pan’’, if shown in coloring added’’ or ‘‘With added artifi- a prominent and legible manner in a cial coloring.’’ When natural coloring size sufficient to insure easy visibility such as annatto is added to edible fats and recognition; or as permitted under part 318 of this sub- (4) On an insert label placed under a chapter, such substance shall be de- transparent covering if clearly visible clared on the label in the same manner and legible and accompanied by the by a phrase such as ‘‘Colored with prefix ‘‘EST’’. annatto.’’ (j) Labels of any product within any (6) When product is placed in a casing of the following paragraphs shall show to which artificial coloring is applied the information required by such para- as permitted under part 318 of this sub- graph for such product: chapter, there shall appear on the

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label, in a prominent manner and con- (13)(i) On the label of any ‘‘Mechani- tiguous to the name of the product, the cally Separated (Species)’’ described in words, ‘‘Artificially colored.’’ § 319.5(a) of this subchapter, the name (7) If a casing is removed from prod- of such product shall be followed im- uct at an official establishment and mediately by the phrase ‘‘for process- there is evidence of artificial coloring ing’’ unless such product has a protein on the surface of the product, there content of not less than 14 percent and shall appear on the label, in a promi- a fat content of not more than 30 per- nent manner and contiguous to the cent. name of product, the words ‘‘Artifi- (ii) When any ‘‘Mechanically Sepa- cially colored.’’ rated (Species)’’ described in § 319.5 of (8) When a casing is colored prior to this subchapter is used as an ingredient its use as a covering for product and in the preparation of a meat food prod- the color is not transferred to the product and such ‘‘Mechanically Separated uct enclosed in the casing, no reference (Species)’’ contributes 20 mg or more of to color need appear on the label but calcium to a serving of such meat food no such casing may be used if it is mis- product, the label of such meat food leading or deceptive with respect to product shall state the calcium content color, quality, or kind of product, or of such meat food product, determined otherwise. and expressed as the percentage of the (9) Product which bears or contains U.S. Recommended Daily Allowance any other artificial coloring, as per- (U.S. RDA) in a serving in accordance mitted under part 318 of this sub- with 21 CFR 101.9(b)(1), (c)(7) (i) and chapter, shall bear a label stating that (iv), and (e), as part of any nutrition fact on the immediate container or if information included on such label, or there is none, on the product. if such meat food product does not bear (10) When an antioxidant is added to nutrition labeling information, as part product as permitted under part 318 of of a prominent statement in immediate this subchapter, there shall appear on conjunction with the list of ingredi- the label in prominent letters and con- ents, as follows: ‘‘A ——— serving contiguous to the name of the product, a tains ——% of the U.S. RDA of cal- statement identifying the officially ap- cium’’, with the blanks to be filled in, proved specific antioxidant by its com- respectively, with the quantity of such mon name or abbreviation thereof and product that constitutes a serving and the purpose for which it is added, such the amount of calcium provided by as, ‘‘BHA, BHT, and Propylgallate such serving: Provided, That, calcium added to help protect flavor.’’ content need not be stated where (a) (11) Containers of meat packed in the percent of the U.S. RDA of calcium borax or other preservative for export to be declared would not differ from to a foreign country which permits the the percent of the U.S. RDA that would use of such preservative shall, at the be declared if the meat food product time of packing, be marked ‘‘for ex- contained only hand deboned ingredi- port,’’ followed on the next line by the ents or (b) the calcium content of a words ‘‘packed in preservative,’’ or serving of the meat food product would such equivalent statement as may be be 20 percent of the U.S. RDA or more approved for this purpose by the Ad- if the meat food product contained ministrator and directly beneath this only hand deboned ingredients. there shall appear the word ‘‘establish- (k) Packaged products which require ment’’ or abbreviation thereof, fol- special handling to maintain their lowed by the number of the establish- wholesome condition shall have promi- ment at which the product is packed. nently displayed on the principal dis- The complete statement shall be ap- play panel of the label the statement: plied in a conspicuous location and in ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ letters not less than 1 inch in height. ‘‘Perishable Keep Under Refrigera- (12) Containers of other product tion,’’ or such similar statement as the packed in, bearing, or containing any Administrator may approve in specific chemical preservative shall bear a cases. Products that are distributed label stating that fact. frozen during distribution and thawed

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prior to or during display for sale at re- information shall be set off by a border tail shall bear the statement on the and shall be one color type printed on shipping container: ‘‘Keep Frozen.’’ a single color contrasting background The consumer-size containers for such whenever practical. products shall bear the statement (2) The labels of the meat and meat ‘‘Previously Handled Frozen for Your products specified in this paragraph (l) Protection, Refreeze or Keep Refrig- shall include the following rationale erated.’’ For all perishable canned statement as part of the safe handling products the statement shall be shown instructions, ‘‘This product was pre- in upper case letters one-fourth inch in pared from inspected and passed meat height for containers having a net and/or poultry. Some food products weight of 3 pounds or less, and for con- may contain bacteria that could cause tainers having a net weight over 3 illness if the product is mishandled or pounds, the statement shall be in upper cooked improperly. For your protec- case letters at least one-half inch in tion, follow these safe handling in- height. structions.’’ This statement shall be (l) Safe handling instructions shall be placed immediately after the heading provided for: All meat and meat prod- and before the safe handling state- ucts of cattle, swine, sheep, goat, ments. horse, or other equine not heat proc- (3) Meat and meat products, specified essed in a manner that conforms to the in this paragraph (l), shall bear the la- time and temperature combinations in beling statements: the Table for Time/Temperature Com- (i) Keep refrigerated or frozen. Thaw bination For Cooked Beef, Roast Beef, in refrigerator or microwave. (Any por- and Cooked Corned Beef in § 318.17, or tion of this statement that is in con- that have not undergone other further flict with the product’s specific han- processing that would render them dling instructions, may be omitted, ready-to-eat; and all comminuted meat e.g., instructions to cook without patties not heat processed in a manner thawing.) (A graphic illustration of a that conforms to the time and temperature combinations in the Table for refrigerator shall be displayed next to Permitted Heat-Processing Tempera- the statement.); ture/Time Combinations For Fully- (ii) Keep raw meat and poultry sepa- Cooked Patties in § 318.23; except as ex- rate from other foods. Wash working empted under paragraph (l)(4) of this surfaces (including cutting boards), section. utensils, and hands after touching raw (1)(i) Safe handling instructions shall meat or poultry. (A graphic illustra- accompany every meat or meat prod- tion of soapy hands under a faucet uct, specified in this paragraph (l) des- shall be displayed next to the state- tined for household consumers, hotels, ment.); restaurants, or similar institutions and (iii) Cook thoroughly. (A graphic il- shall appear on the label. The informa- lustration of a skillet shall be dis- tion shall be in lettering no smaller played next to the statement.); and than one-sixteenth of an inch in size (iv) Keep hot foods hot. Refrigerate and shall be prominently placed with leftovers immediately or discard. (A such conspicuousness (as compared graphic illustration of a thermometer with other words, statements, designs shall be displayed next to the state- or devices in the labeling) as to render ment.) it likely to be read and understood by (4) Meat or meat products intended the ordinary individual under cus- for further processing at another offi- tomary conditions of purchase and use. cial establishment are exempt from the (ii) The safe handling information requirements prescribed in paragraphs shall be presented on the label under (l)(1) through (l)(3) of this section. the heading ‘‘Safe Handling Instruc- (m)(1) The information panel is that tions’’ which shall be set in type size part of a label that is the first surface larger than the print size of the ration- to the right of the principal display ale statement and handling statements panel as observed by an individual fac- as discussed in paragraphs (l)(2) and ing the principal display panel, with (l)(3) of this section. The safe handling the following exceptions:

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(i) If the first surface to the right of effect as the respective marks for the principal display panel is too small which they are authorized abbrevia- to accommodate the required informa- tions. tion or is otherwise unusable label (b) Except for the purposes of prepar- space, e.g., folded flaps, tear strips, ing and submitting a sample or sam- opening flaps, heat-sealed flaps, the ples of the same to the Administrator next panel to the right of this part of for approval, no brand manufacturer, the label may be used. printer, or other person shall cast, (ii) If the package has one or more al- print, lithograph, or otherwise make ternate principal display panels, the in- any marking device containing any of- formation panel is to the right of any ficial mark or simulation thereof, or principal display panel. any label bearing any such mark or (iii) If the top of the container is the simulation, without the written au- principal display panel and the pack- thority therefor of the Administrator. age has no alternate principal display However, when any such sample label, panel, the information panel is any or other marking device, is approved panel adjacent to the principal display by the Administrator, additional sup- panel. plies of the approved label, or marking (2) (i) Except as otherwise permitted device, may be made for use in accord- in this part, all information required to ance with the regulations in this sub- appear on the principal display panel chapter, without further approval by or permitted to appear on the informa- the Administrator. The provisions of tion panel shall appear on the same this paragraph apply only to labels, or panel unless there is insufficient space. other marking devices, bearing or con- In determining the sufficiency of the taining an official inspection legend available space, except as otherwise shown in § 312.2(b), § 312.3(a) (only the prescribed in this part, any vignettes, legend appropriate for horse meat food designs, and any other nonmandatory products) or § 312.3(b) (only the legend information shall not be considered. If appropriate for other (nonhorse) equine there is insufficient space for all re- meat food products), or any abbrevia- quired information to appear on a sin- tions, copy or representation thereof. gle panel, it may be divided between (c) No brand manufacturer or other the principal display panel and the in- person shall cast or otherwise make, formation panel, provided that the in- without an official certificate issued in formation required by any given provi- quadruplicate by a Program employee, sion of this part, such as the ingredi- a brand or other marking device con- ents statement, is not divided and ap- taining an official inspection legend, or pears on the same panel. simulation thereof, shown in § 312.2(a), (ii) All information appearing on the § 312.3(a) (only the legend appropriate information panel pursuant to this sec- for horse carcasses and parts of horse tion shall appear in one place without carcasses), § 312.3(b) (only the legend intervening material, such as designs appropriate for other equine (nonhorse) or vignettes. carcasses and parts of other (nonhorse) [35 FR 15580, Oct. 3, 1970] equine carcasses) or § 312.7(a). (1) The certificate is a Food Safety EDITORIAL NOTE: For FEDERAL REGISTER ci- and Inspection Service form for signa- tations affecting § 317.2, see the List of Sec- ture by a Program employee and the tions Affected in the Finding Aids section of this volume. official establishment ordering the brand or other marking device, bearing § 317.3 Approval of abbreviations of a certificate serial number and a let- marks of inspection; preparation of terhead and the seal of the United marking devices bearing inspection States Department of Agriculture. The legend without advance approval certificate authorizes the making of prohibited; exception. only the brands or other marking de- (a) The Administrator may approve vices of the type and quantity listed on and authorize the use of abbreviations the certificate. of marks of inspection under the regu- (2) After signing the certificate, the lations in this subchapter. Such abbre- Program employee and the establish- viations shall have the same force and ment shall each keep a copy, and the

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remaining two copies shall be given to resentative of the Secretary upon re- the brand or other marking device quest. manufacturer. (b) The Food Labeling Division shall (3) The manufacturer of the brands or permit submission for approval of only other marking devices shall engrave or sketch labeling, as defined in § 317.4(d), otherwise mark each brand or other for all products, except as provided in marking device with a permanent iden- § 317.5(b) (2)–(9) and except for tem- tifying serial number unique to it. The porary use of final labeling as pre- manufacturer shall list on each of the scribed in paragraph (f) of this section. two copies of the certificate given to (c) All labeling required to be sub- the manufacturer the number of each mitted for approval as set forth in brand or other marking device author- § 317.4(a) shall be submitted in dupli- ized by the certificate. The manufac- cate to the Food Labeling Division, turer shall retain one copy of the cer- Regulatory Programs, Food Safety and tificate for the manufacturer’s records Inspection Service, U.S. Department of and return the remaining copy with Agriculture, Washington, DC 20250. A the brands or other marking devices to parent company for a corporation may the Program employee whose name and submit only one labeling application address are given on the certificate as (in duplicate form) for a product pro- the recipient. duced in other establishments that are (4) In order that all such brands or owned by the corporation. other marking devices bear identifying (d) ‘‘Sketch’’ labeling is a printer’s numbers, within one year after June 24, proof or equivalent which clearly 1985, an establishment shall either re- shows all labeling features, size, loca- place each such brand or other mark- tion, and indication of final color, as ing device which does not bear an iden- specified in § 317.2. FSIS will accept tifying number, or, under the direction sketches that are hand drawn, com- of the inspector-in-charge, mark such puter generated or other reasonable brand or other marking device with a facsimiles that clearly reflect and permanent identifying number. project the final version of the labeling. Indication of final color may be (Recordkeeping requirements approved by met by: submission of a color sketch, the Office of Management and Budget under submission of a sketch which indicates control number 0583–0015) by descriptive language the final col- [35 FR 15580, Oct. 3, 1970, as amended at 50 FR ors, or submission with the sketch of 21422, May 24, 1985] previously approved final labeling that indicates the final colors. § 317.4 Labeling approval. (e) Inserts, tags, liners, pasters, and (a) No final labeling shall be used on like devices containing printed or any product unless the sketch labeling graphic matter and for use on, or to be of such final labeling has been submit- placed within, containers and coverings ted for approval to the Food Labeling of product shall be submitted for ap- Division, Regulatory Programs, Food proval in the same manner as provided Safety and Inspection Service, and ap- for labeling in § 317.4(a), except that proved by such division, accompanied such devices which contain no ref- by FSIS form, Application for Approval erence to product and bear no mislead- of Labels, Marking, and Devices, ex- ing feature shall be used without sub- cept for generically approved labeling mission for approval as prescribed in authorized for use in § 317.5(b). The § 317.5(b)(7). management of the official establish- (f)(1) Consistent with the requirement or establishment certified under ments of this section, temporary ap- a foreign inspection system, in accord- proval for the use of a final label or ance with part 327 of this subchapter, other final labeling that may otherwise must maintain a copy of all labeling be deemed deficient in some particular used, along with the product formula- may be granted by the Food Labeling tion and processing procedure, in ac- Division. Temporary approvals may be cordance with part 320 of this sub- granted for a period not to exceed 180 chapter. Such records shall be made calendar days, under the following con- available to any duly authorized rep- ditions:

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(i) The proposed labeling would not does not contain any special claims, misrepresent the product; such as quality claims, nutrient con- (ii) The use of the labeling would not tent claims, health claims, negative present any potential health, safety, or claims, geographical origin claims, or dietary problems to the consumer; guarantees, or which is not a domestic (iii) Denial of the request would cre- product labeled in a foreign language; ate undue economic hardship; and (2) Labeling for single-ingredient (iv) An unfair competitive advantage products (such as beef steak or lamb would not result from the granting of chops) which does not contain any spe- the temporary approval. cial claims, such as quality claims, nu- (2) Extensions of temporary approv- trient content claims, health claims, als may also be granted by the Food negative claims, geographical origin Labeling Division provided that the ap- claims, or guarantees, or which is not a plicant demonstrates that new cir- domestic product labeled with a for- cumstances, meeting the above cri- eign language; teria, have developed since the original (3) Labeling for containers of prod- temporary approval was granted. ucts sold under contract specifications (g) The inspector-in-charge shall ap- to Federal Government agencies, when prove meat carcass ink brands and such product is not offered for sale to meat food product ink and burning the general public, provided that the brands, which comply with parts 312 contract specifications include specific and 316 of this subchapter. requirements with respect to labeling, [60 FR 67454, Dec. 29, 1995] and are made available to the inspector-in-charge; § 317.5 Generically approved labeling. (4) Labeling for shipping containers (a)(1) An official establishment or an which contain fully labeled immediate establishment certified under a foreign containers, provided such labeling inspection system, in accordance with complies with § 316.13; part 327 of this subchapter, is author- (5) Labeling for products not in- ized to use generically approved label- tended for human food, provided they ing, as defined in paragraph (b) of this comply with part 325 of this subsection, without such labeling being chapter; submitted for approval to the Food (6) Meat inspection legends, which Safety and Inspection Service in Wash- comply with parts 312 and 316 of this ington or the field, provided the label- subchapter; ing is in accordance with this section (7) Inserts, tags, liners, pasters, and and shows all mandatory features in a like devices containing printed or prominent manner as required in graphic matter and for use on, or to be § 317.2, and is not otherwise false or placed within containers, and coverings misleading in any particular. of products, provided such devices con- (2) The Food Safety and Inspection tain no reference to product and bear Service shall select samples of generi- no misleading feature; cally approved labeling from the (8) Labeling for consumer test prod- records maintained by official estab- ucts not intended for sale; and lishments and establishments certified (9) Labeling which was previously ap- under foreign inspection systems, in proved by the Food Labeling Division accordance with part 327 of this sub- as sketch labeling, and the final label- chapter, as required in § 317.4, to deter- ing was prepared without modification mine compliance with labeling require- or with the following modifications: ments. Any finding of false or mislead- (i) All features of the labeling are ing labeling shall institute the pro- proportionately enlarged or reduced, ceedings prescribed in § 335.12. provided that all minimum size re- (b) Generically approved labeling is quirements specified in applicable reg- labeling which complies with the fol- ulations are met and the labeling is lowing: legible; (1) Labeling for a product which has (ii) The substitution of any unit of a product standard as specified in part measurement with its abbreviation or 319 of this subchapter or the Standards the substitution of any abbreviation and Labeling Policy Book and which with its unit of measurement, e.g.,

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‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for (xv) The deletion of the word ‘‘new’’ ‘‘ounce,’’ or of the word ‘‘pound’’ for on new product labeling; ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; (xvi) The addition, deletion, or (iii) A master or stock label has been amendment of special handling state- approved from which the name and ad- ments, provided that the change is con- dress of the distributor are omitted and sistent with § 317.2(k); such name and address are applied be- (xvii) The addition of safe handling fore being used (in such case, the words instructions as required by § 317.2(l); ‘‘prepared for’’ or similar statement (xviii) Changes reflecting a change in must be shown together with the blank the quantity of an ingredient shown in space reserved for the insertion of the the formula without a change in the name and address when such labels are order of predominance shown on the offered for approval); label, provided that the change in (iv) Wrappers or other covers bearing quantity of ingredients complies with pictorial designs, emblematic designs any minimum or maximum limits for or illustrations, e.g., floral arrange- the use of such ingredients prescribed ments, illustrations of animals, fire- in parts 318 and 319 of this subchapter; works, etc. are used with approved la- (xix) Changes in the color of the labeling (the use of such designs will not beling, provided that sufficient con- make necessary the application of la- trast and legibility remain; beling not otherwise required); (xx) A change in the product vi- (v) A change in the language or the gnette, provided that the change does arrangement of directions pertaining not affect mandatory labeling informa- to the opening of containers or the tion or misrepresent the content of the serving of the product; package; (vi) The addition, deletion, or amend- (xxi) A change in the establishment ment of a dated or undated coupon, a number by a corporation or parent cents-off statement, cooking instruc- company for an establishment under tions, packer product code informa- its ownership; tion, or UPC product code information; (xxii) Changes in nutrition labeling (vii) Any change in the name or ad- that only involve quantitative adjust- dress of the packer, manufacturer or ments to the nutrition labeling infor- distributor that appears in the signa- mation, except for serving sizes, pro- ture line; vided the nutrition labeling informa- (viii) Any change in the net weight, tion maintains its accuracy and con- provided the size of the net weight sistency; statement complies with § 317.2; (xxiii) Deletion of any claim, and the (ix) The addition, deletion, or amend- deletion of non-mandatory features or ment of recipe suggestions for the non-mandatory information; and product; (xxiv) The addition or deletion of a (x) Any change in punctuation; direct translation of the English lan- (xi) Newly assigned or revised estab- guage into a foreign language for prod- lishment numbers for a particular es- ucts marked ‘‘for export only.’’ tablishment for which use of the label- [60 FR 67455, Dec. 29, 1995] ing has been approved by the Food La- beling Division, Regulatory Programs; § 317.6 Approved labels to be used only (xii) The addition or deletion of open on products to which they are ap- dating information; plicable. (xiii) A change in the type of packag- Labels shall be used only on products ing material on which the label is for which they are approved, and only printed; if they have been approved for such (xiv) Brand name changes, provided products in accordance with § 317.3: Pro- that there are no design changes, the vided, That existing stocks of labels ap- brand name does not use a term that proved prior to the effective date of connotes quality or other product char- this section and the quantity of which acteristics, the brand name has no geo- has been identified to the circuit super- graphic significance, and the brand visor as being in storage on said date name does not affect the name of the at the official establishment or other product; identified warehouse for the account of

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the operator of the official establish- (b) The labels and containers of prod- ment may be used until such stocks are uct shall comply with the following exhausted, but not later than 1 year provisions, as applicable: after the effective date of this section (1) Terms having geographical sig- unless such labels conform to all the nificance with reference to a locality requirements of this part and part 319 other than that in which the product is of this subchapter. The Administrator prepared may appear on the label only may upon the show of good cause grant when qualified by the word ‘‘style,’’ individual extension of time as he ‘‘type,’’ or ‘‘brand,’’ as the case may be, deems necessary. in the same size and style of lettering as in the geographical term, and ac- § 317.7 Products for foreign commerce; companied with a prominent qualifying printing labels in foreign language statement identifying the country, permissible; other deviations. State, Territory, or locality in which Labels to be affixed to packages of the product is prepared, using terms products for foreign commerce may be appropriate to effect the qualification. printed in a foreign language and may When the word ‘‘style’’ or ‘‘type’’ is show the statement of the quantity of used, there must be a recognized style contents in accordance with the usage or type of product identified with and of the country to which exported and peculiar to the area represented by the other deviations from the form of la- geographical term and the product beling required under this part may be must possess the characteristics of approved for such product by the Ad- such style or type, and the word ministrator in specific cases: Provided, ‘‘brand’’ shall not be used in such a (a) That the proposed labeling ac- way as to be false or misleading: Pro- cords to the specifications of the for- vided, That a geographical term which eign purchaser, has come into general usage as a trade (b) That it is not in conflict with the name and which has been approved by laws of the country to which the prod- the Administrator as being a generic uct is intended for export, and term may be used without the quali- (c) That the outside container is la- fications provided for in this para- beled to show that it is intended for ex- graph. The terms ‘‘frankfurter,’’ ‘‘vi- port; but if such product is sold or of- enna,’’ ‘‘bologna,’’ ‘‘lebanon bologna,’’ fered for sale in domestic commerce, ‘‘braunschweiger,’’ ‘‘thuringer,’’ all the requirements of this subchapter ‘‘genoa,’’ ‘‘leona,’’ ‘‘berliner,’’ ‘‘hol- apply. The inspection legend and the stein,’’ ‘‘goteborg,’’ ‘‘milan,’’ ‘‘polish,’’ establishment number shall in all cases ‘‘italian,’’ and their modifications, as appear in English but in addition, may applied to sausages, the terms ‘‘bruns- appear literally translated in a foreign wick’’ and ‘‘irish’’ as applied to stews language. and the term ‘‘boston’’ as applied to pork shoulder butts need not be accom- § 317.8 False or misleading labeling or panied with the word ‘‘style,’’ ‘‘type,’’ practices generally; specific prohi- or ‘‘brand,’’ or a statement identifying bitions and requirements for labels the locality in which the product is and containers. prepared. (a) No product or any of its wrappers, (2) Such terms as ‘‘farm’’ or ‘‘coun- packaging, or other containers shall try’’ shall not be used on labels in con- bear any false or misleading marking, nection with products unless such label, or other labeling and no state- products are actually prepared on the ment, word, picture, design, or device farm or in the country: Provided, That which conveys any false impression or if the product is prepared in the same gives any false indication of origin or way as on the farm or in the country quality or is otherwise false or mis- these terms, if qualified by the word leading shall appear in any marking or ‘‘style’’ in the same size and style of other labeling. No product shall be lettering, may be used: Provided fur- wholly or partly enclosed in any wrap- ther, That the term ‘‘farm’’ may be per, packaging, or other container that used as part of a brand designation is so made, formed, or filled as to be when qualified by the word ‘‘brand’’ in misleading. the same size and style of lettering,

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and followed with a statement identify- ages for sliced bacon which meet the ing the locality in which the product is following specifications will be accept- prepared: And Provided further, That ed as meeting the requirements of this the provisions of this paragraph shall subparagraph provided the enclosed not apply to products prepared in ac- bacon is positioned so that the cut sur- cordance with § 319.106 of this sub- face of the representative slice can be chapter. Sausage containing cereal visually examined: shall not be labeled ‘‘farm style’’ or (a) For shingle-packed sliced bacon, ‘‘country style,’’ and lard not rendered the transparent window shall be de- in an open kettle shall not be des- signed to reveal at least 70 percent of ignated as ‘‘farm style’’ or ‘‘country the length (longest dimension) of the style.’’ representative slice, and this window (3) The requirement that the label shall be at least 11⁄2 inches wide. The shall contain the name and place of transparent window shall be located business of the manufacturer, packer, not more than five-eighths inch from or distributor shall not relieve any es- the top or bottom edge of a 1-pound or tablishment from the requirement that smaller package and not more than its label shall not be misleading in any three-fourths inch from either the top particular. or bottom edge of a package larger (4) The term ‘‘spring lamb’’ or ‘‘genu- than 1 pound. ine spring lamb’’ is applicable only to (b) For stack-packed sliced bacon, carcasses of new-crop lambs slaugh- the transparent window shall be de- tered during the period beginning in signed to reveal at least 70 percent of March and terminating not beyond the the length (longest dimension) of the close of the week containing the first representative slice and be at least 11⁄2 Monday in October. inches wide. (5)(i) Coverings shall not be of such (6) The word ‘‘fresh’’ shall not be color, design, or kind as to be mislead- used on labels to designate product ing with respect to color, quality, or which contains any sodium nitrate, so- kind of product to which they are ap- dium nitrite, potassium nitrate, or po- plied. For example, transparent or tassium nitrite, or which has been salt- semitransparent coverings for such ar- ed for preservation. ticles as sliced bacon or fresh (7)(i) No ingredient shall be des- (uncooked) meat and meat food prod- ignated on the label as a spice, flavor- ucts shall not bear lines or other de- ing, or coloring unless it is a spice, fla- signs of red or other color which give a voring, or coloring, as the case may be. false impression of leanness of the An ingredient that is both a spice and product. Transparent or a coloring, or both a flavoring and a semitransparent wrappers, casings, or coloring, shall be designated as ‘‘spice coverings for use in packaging cured, and coloring’’, or ‘‘flavoring and color- cured and smoked, or cured and cooked ing’’, as the case may be, unless such sausage products, and sliced ready-to- ingredient is designated by its common eat meat food products may be color or usual name. tinted or bear red designs on 50 percent (ii) Any ingredient not designated in of such wrapper or covering: Provided, § 317.2(f)(1)(i) of this part whose func- That the transparent or tion is flavoring, either in whole or in semitransparent portion of the prin- part, must be designated by its com- cipal display panel is free of color tint- mon or usual name. Those ingredients ing and red designs: And provided fur- which are of livestock and poultry ori- ther, That the principal display panel gin must be designated by names that provides at least 20 percent unob- include the species and livestock and structed clear space, consolidated in poultry tissues from which the ingredi- one area so that the true nature and ents are derived. color of the product is visible to the (8) As used on labels of product, the consumer. term ‘‘gelatin’’ shall mean (i) the jelly (ii) Packages for sliced bacon that prepared in official establishments by have a transparent opening shall be de- cooking pork skins, tendons, or consigned to expose, for viewing, the cut nective tissue from inspected and surface of a representative slice. Pack- passed product, and (ii) dry commercial

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gelatin or the jelly resulting from its moved, thus eliminating the entire use. tibia and fibula, or radius and ulna, re- (9) Product (other than canned prod- spectively, together with the overlying uct) labeled with the term ‘‘loaf’’ as muscle, skin, and other tissue. part of its name: (15) Such terms as ‘‘meat extract’’ or (i) If distributed from the official es- ‘‘extract of beef’’ without qualification tablishment in consumer size contain- shall not be used on labels in connec- ers may be in any shape; tion with products prepared from or- (ii) If distributed in a container of a gans or other parts of the carcass, size larger than that sold intact at re- other than fresh meat. Extracts pre- tail the product shall be prepared in pared from any parts of the carcass rectangular form, or as in paragraph other than fresh meat may be properly (b)(9)(iii) of this section; labeled as extracts with the true name (iii) If labeled as an ‘‘Old Fashioned of the parts from which prepared. In Loaf’’ shall be prepared in a traditional the case of extract in fluid form, the form, such as rectangular with rounded word ‘‘fluid’’ shall also appear on the top or circular with flat bottom and label, as, for example, ‘‘fluid extract of rounded top. beef.’’ (10) The term ‘‘baked’’ shall apply (16) [Reserved] only to product which has been cooked (17) When any product is enclosed in by the direct action of dry heat and for a container along with a packing sub- a sufficient time to permit the product stance such as brine, vinegar, or agar to assume the characteristics of a jelly, a declaration of the packing sub- baked article, such as the formation of stance shall be printed prominently on a brown crust on the surface, rendering the label as part of the name of the out of surface fat, and the product, as for example, ‘‘frankfurts caramelization of the sugar if applied. packed in brine,’’ ‘‘lamb tongue packed Baked loaves shall be heated to a tem- in vinegar,’’ or ‘‘beef tongue packed in perature of at least 160 °F. and baked agar jelly,’’ as the case may be. The pork cuts shall be heated to an internal packing substance shall not be used in temperature of at least 170 °F. such a manner as will result in the con- (11) When products such as loaves are tainer being so filled as to be mislead- browned by dipping in hot edible oil or ing. by a flame, the label shall state such (18) ‘‘Leaf lard’’ is lard prepared from fact, e.g., by the words ‘‘Browned in fresh leaf fat. Hot Cottonseed Oil’’ or ‘‘Browned by a (19) When lard or hardened lard is Flame,’’ as the case may be, appearing mixed with rendered pork fat or hard- as part of the product name. ened rendered pork fat, the mixture (12) The term ‘‘meat’’ and the names shall be designated as ‘‘rendered pork of particular kinds of meat, such as fat’’ or ‘‘hardened rendered pork fat,’’ beef, veal, mutton, lamb, and pork, as the case may be. shall not be used in such manner as to (20) Oil, stearin, or stock obtained be false or misleading. from beef or mutton fats rendered at a (13) The word ‘‘ham,’’ without any temperature above 170 °F. shall not be prefix indicating the species of animal designated as ‘‘oleo oil,’’ ‘‘oleo stea- from which derived, shall be used in la- rin,’’ or ‘‘oleo stock,’’ respectively. beling only in connection with the hind (21) When not more than 20 percent of legs of swine. Ham shanks as such or beef fat, mutton fat, oleo stearin, vege- ham shank meat as such or the trim- table stearin, or hardened vegetable fat mings accruing in the trimming and is mixed with lard or with rendered shaping of hams shall not be labeled pork fat, there shall appear on the ‘‘ham’’ or ‘‘ham meat’’ without quali- label, contiguous to and in the same fication. When used in connection with size and style of lettering as the name a chopped product the term ‘‘ham’’ or of the product, the words ‘‘beef fat ‘‘ham meat’’ shall not include the skin. added,’’ ‘‘mutton fat added,’’ ‘‘oleo ste- (14) The terms ‘‘shankless’’ and arin added,’’ ‘‘vegetable stearin added,’’ ‘‘hockless’’ shall apply only to hams or ‘‘hardened vegetable fat added,’’ as and pork shoulders from which the the case may be. If more than 20 per- shank or hock has been completely recent is added, the product name shall

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refer to the particular animal fat or (25) When approved proteolytic en- fats used, such as, ‘‘Lard and Beef zymes as permitted in part 318 of this Fat.’’ The designation ‘‘vegetable fat’’ subchapter are used on steaks or other is applicable to vegetable oil, vegetable raw meat cuts, there shall appear on stearin, or a combination of such oil the label, in a prominent manner, con- and stearin, whereas the designations tiguous to the product name, the state- ‘‘vegetable oil’’ and ‘‘vegetable stea- ment, ‘‘Tenderized with [approved en- rin’’ shall be applicable only to the oil zyme],’’ to indicate the use of such en- and the stearin respectively, when used zymes. Any other approved substance in meat food products. which may be used in the solution shall (22) Cooked, cured, or pickled pigs also be included in the statement. feet, pigs knuckles, and similar prod- When approved inorganic chlorides as ucts, shall be labeled to show that the permitted in part 318 of this subchapter bones remain in the product, if such is are used on steaks or other raw meat the case. The designation ‘‘semi- cuts there shall appear on the label in boneless’’ shall not be used if less than a prominent manner, contiguous to the 50 percent of the total weight of bones product name, the statement, ‘‘Tender- has been removed. ized with (names of approved inorganic (23) When monoglycerides, chloride(s))’’ to indicate the use of such diglycerides, and/or polyglycerol esters inorganic chlorides. Any other ap- of fatty acids are added to rendered proved substance which may be in the animal fat or a combination of such fat and vegetable fat, there shall appear on the label in a prominent manner and type or lettering not smaller than 20-point contiguous to the name of the product type. The requirements of this subsection shall a statement such as ‘‘With be in addition to and not in lieu of any of the Monoglycerides and Diglycerides other requirements of this Act. Added,’’ or ‘‘With Diglycerides and (c) No person shall possess in a form ready Monoglycerides,’’ or ‘‘With Polyglyc- for serving colored oleomargarine or colored erol Esters of Fatty Acids’’ as the case margarine at a public eating place unless a may be. notice that oleomargarine or margarine is (24) Section 407 of the Federal Food, served is displayed prominently and con- Drug, and Cosmetic Act contains provi- spicuously in such place and in such manner sions with respect to colored margarine as to render it likely to be read and understood by the ordinary individual being served or colored oleomargarine (21 U.S.C. 347) in such eating place or is printed or is other- 1 which are set forth herein as footnote. wise set forth on the menu in type or lettering not smaller than that normally used to 1 ‘‘Sec. 407(a) Colored oleomargarine or col- designate the serving of other food items. No ored margarine which is sold in the same person shall serve colored oleomargarine or State or Territory in which it is produced colored margarine at a public eating place, shall be subject in the same manner and to whether or not any charge is made therefor, the same extent to the provisions of this Act unless (1) each separate serving bears or is as if it had been introduced in interstate accompanied by labeling identifying it as commerce. oleomargarine or margarine, or (2) each sep- (b) No person shall sell, or offer for sale, arate serving thereof is triangular in shape. colored oleomargarine or colored margarine (d) Colored oleomargarine or colored mar- unless— garine when served with meals at a public (1) Such oleomargarine or margarine is eating place shall at the time of such service packaged, be exempt from the labeling requirements of (2) The net weight of the contents of any section 343 of this Act (except subsection (a) package sold in a retail establishment is one and (f) of section 343 of this title) if it compound or less, plies with the requirements of subsection (b) (3) There appears on the label of the pack- of this section. age (A) The word ‘oleomargarine’ or ‘mar- (e) For the purpose of this section colored garine’ in type or lettering at least as large oleomargarine or colored margarine is oleo- as any other type or lettering on such label, margarine or margarine having a tint or and (B) A full and accurate statement of all shade containing more than one and six the ingredients contained in such oleo- tenths degrees of yellow or of yellow and red margarine, or margarine, and collectively, but with an excess of yellow (4) Each part of the contents of the pack- over red, measured in terms of Lovibond age is contained in a wrapper which bears tintometer scale or its equivalent’’ (21 U.S.C. the word ‘oleomargarine’ or ‘margarine’ in 347).

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solution shall also be included in the year in the case of products hermeti- statement. cally sealed in metal or glass contain- (26) When dimethylpolysiloxan is ers, dried or frozen products, or any added as an antifoaming agent to ren- other products that the Administrator dered fats, its presence shall be de- finds should be labeled with the year clared on the label contiguous to the because the distribution and marketing name of the product. Such declaration practices with respect to such products shall read ‘‘Dimethylpolysiloxan may cause a label without a year iden- Added.’’ tification to be misleading. (27) When pizzas are formulated with (ii) Immediately adjacent to the cal- crust containing calcium propionate or endar date shall be a phrase explaining sodium propionate, there shall appear the meaning of such date, in terms of on the label contiguous to the name of ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use the product the statement ‘‘———— before’’ date, with or without a further added to retard spoilage of crust’’ pre- qualifying phrase, e.g., ‘‘For Maximum ceded by the name of the preservative. Freshness’’ or ‘‘For Best Quality’’, and (28) Sausage of the dry varieties such phrases shall be approved by the treated with potassium sorbate or Administrator as prescribed in § 317.4. propylparaben (propyl p- (33) [Reserved] hydroxybenzoate) as permitted by part (34) The terms ‘‘All,’’ ‘‘Pure,’’ 318 of this subchapter, shall be marked ‘‘100%,’’ and terms of similar connota- or labeled with a statement disclosing tion shall not be used on labels for such treatment and the purpose there- products to identify ingredient con- of, such as ‘‘dipped in a potassium sor- tent, unless the product is prepared bate solution to retard mold growth.’’ solely from a single ingredient. (29) Meat of goats shall be identified (35) When agar-agar is used in canned as goat meat or chevon. jellied meat food products, as per- (30) The term ‘‘Chitterlings’’ shall mitted in part 318 of this subchapter, apply to the large intestines of swine, there shall appear on the label in a or young bovine animals when preceded prominent manner, contiguous to the with the word ‘‘Calf’’ or ‘‘Veal.’’ Meat product name, a statement to indicate food products that contain chitterlings the use of agar-agar. or calf or veal chitterlings, in accord- (36) When sodium alginate, calcium ance with § 318.6(b)(8) of this subchapter carbonate, and lactic acid and calcium shall be identified with product names carbonate (or glucono delta-lactone) that refer to such ingredients, as for are used together in a dry binding ma- instance, ‘‘Chitterling Loaf,’’ trix in restructured, formed meat food ‘‘Chitterling Pie,’’ or ‘‘Calf Chitterlings products, as permitted in part 318 of and Gravy,’’ and shall be packed in this subchapter, there shall appear on containers having a capacity of 3 the label contiguous to the product pounds or less and of a kind usually name, a statement to indicate the use sold at retail intact and bearing such of sodium alginate, calcium carbonate other information as is required by this and lactic acid and calcium carbonate part. (or glucono delta-lactone). (31) Products that contain blood from (37) [Reserved] livestock as permitted by part 318 of [35 FR 15580, Oct. 3, 1970] this subchapter shall be labeled with a EDITORIAL NOTE: For FEDERAL REGISTER ci- name that includes the term ‘‘blood,’’ tations affecting § 317.8, see the List of CFR and the specific kind of blood shall be Sections Affected in the Finding Aids sec- declared in the ingredient statement, tion of this volume. e.g., ‘‘Swine blood,’’ in the manner required by this part. § 317.9 Labeling of equine products. (32) A calendar date may be shown on The immediate containers of any labeling when declared in accordance equine products shall be labeled to with the provisions of this subpara- show the kinds of animals from which graph: derived when the products are sold, (i) The calendar date shall express transported, offered for sale or trans- the month of the year and the day of portation or received for transpor- the month for all products and also the tation in commerce.

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§ 317.10 Reuse of official inspection product because the labels have be- marks; reuse of containers bearing come mutilated or otherwise damaged, official marks, labels, etc. a request for relabeling the product (a) No official inspection legend or shall be sent to the Administrator, ac- other official mark which has been pre- companied with a statement of the rea- viously used shall be used again for the sons therefor. Labeling material in- identification of any product, except as tended for relabeling inspected and provided for in paragraph (b) of this passed product shall not be transported section. from an official establishment until (b) All stencils, marks, labels, or permission has been received from the other labeling on previously used con- Administrator. The relabeling of in- tainers, whether relating to any prod- spected and passed product with labels uct or otherwise, shall be removed or bearing any official marks shall be obliterated before such containers are done under the supervision of a Pro- used for any product, unless such label- gram inspector. The official establishing correctly indicates the product to ment shall reimburse the Program, in be packed therein and such containers accordance with the regulations of the are refilled under the supervision of a Department, for any cost involved in Program employee. supervising the relabeling of such product. § 317.11 Labeling, filling of containers, handling of labeled products to be § 317.13 Storage and distribution of la- only in compliance with regula- bels and containers bearing official tions. marks. (a) No person shall in any official es- Labels, wrappers, and containers tablishment apply or affix, or cause to bearing any official marks, with or be applied or affixed, any label to any without the establishment number, product prepared or received in such may be transported from one official establishment, or to any container establishment to any other official es- thereof, or fill any container at such an tablishment provided such shipments establishment, except in compliance are made with the prior authorization with the regulations in this sub- of the inspector in charge at point of chapter. origin, who will notify the inspector in (b) No covering or other container charge at destination concerning the shall be filled, in whole or in part, at date of shipment, quantity, and type of any official establishment with any labeling material involved. No such product unless it has been inspected material shall be used at the establish- and passed in compliance with the reg- ment to which it is shipped unless such ulations in this subchapter, is not adul- use conforms with the requirements of terated, and is strictly in accordance this subchapter. with the statements on the label, and such filling is done under the super- §§ 317.14–317.15 [Reserved] vision of a Program employee. (c) No person shall remove, or cause § 317.16 Labeling and containers of to be removed from an official estab- custom prepared products. lishment any product bearing a label Products that are custom prepared unless such label is in compliance with under § 303.1(a)(2) of this subchapter the regulations in this subchapter, or must be packaged immediately after any product not bearing a label re- preparation and must be labeled (in quired by such regulations. lieu of information otherwise required § 317.12 Relabeling products; require- by this part 317) with the words ‘‘Not ments. For Sale’’ in lettering not less than three-eighth inch in height. Such ex- When it is claimed by an official es- empted custom prepared products or tablishment that any of its products their containers may bear additional which bore labels bearing official labeling provided such labeling is not marks has been transported to a loca- false or misleading. tion other than an official establishment, and it is desired to relabel the [37 FR 4071, Feb. 26, 1972]

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§ 317.17 Interpretation and statement (3) Products described in paragraph of labeling policy for cured prod- (b) of this section and § 319.2 of this ucts; special labeling requirements subchapter shall not be subject to the concerning nitrate and nitrite. labeling requirements of paragraphs (b) (a) With respect to sections 1(n) (7), and (c) of this section if they contain (9), and (12) of the Act and § 317.2, any an amount of salt sufficient to achieve substance mixed with another sub- a brine concentration of 10 percent or stance to cure a product must be iden- more. tified in the ingredients statement on [37 FR 16863, Aug. 22, 1972, as amended at 44 the label of such product. For example, FR 48961, Aug. 21, 1979] curing mixtures composed of such ingredients as water, salt, sugar, sodium § 317.18 Quantity of contents labeling. phosphate, sodium nitrate, and sodium Sections 317.18 through 317.22 of this nitrite or other permitted substances part prescribe the procedures to be fol- which are added to any product, must lowed for determining net weight com- be identified on the label of the prod- pliance and prescribe the reasonable uct by listing each such ingredient in variations from the declared net accordance with the provisions of weight on the labels of immediate con- § 317.2. tainers of products in accordance with (b) Any product, such as bacon and § 317.2(h) of this part. pepperoni, which is required to be labeled by a common or usual name or [55 FR 49834, Nov. 30, 1990] descriptive name in accordance with § 317.2(c)(1) and to which nitrate or ni- § 317.19 Definitions and procedures for trite is permitted or required to be determining net weight compliance. added may be prepared without nitrate (a) For the purpose of §§ 317.18 or nitrite and labeled with such com- through 317.22 of this part, the reason- mon or usual name or descriptive name able variations allowed, definitions, when immediately preceded with the and procedures to be used in determin- term ‘‘Uncured’’ as part of the product ing net weight and net weight compli- name in the same size and style of let- ance are described in the National In- tering as the product name, provided stitute of Standards and Technology that the product is found by the Ad- (NIST) Handbook 133, ‘‘Checking the ministrator to be similar in size, fla- Net Contents of Packaged Goods,’’ vor, consistency, and general appear- Third Edition, September 1988, and ance to such product as commonly pre- Supplements 1, 2, 3, and 4 dated Sep- pared with nitrate or nitrite, or both. tember 1990, October 1991, October 1992, (c)(1) Products described in para- and October 1994, respectively, which graph (b) of this section or § 319.2 of are incorporated by reference, with the this subchapter, which contain no ni- exception of the NIST Handbook 133 trate or nitrite shall bear the state- and Supplements 1, 3, and 4 requirement ‘‘No Nitrate or Nitrite Added.’’ ments listed in paragraphs (b) and (c) This statement shall be adjacent to the of this section. Those provisions incor- product name in lettering of easily porated by reference herein, are consid- readable style and at least one-half the ered mandatory requirements. This in- size of the product name. corporation was approved by the Direc- (2) Products described in paragraph tor of the Federal Register in accord- (b) of this section and § 319.2 of this ance with 5 U.S.C. 552(a) and 1 CFR subchapter shall bear, adjacent to the part 51. (These materials are incor- product name in lettering of easily porated as they exist on the date of ap- readable style and at least one-half the proval.) A notice of any change in the size of the product name, the state- Handbook cited herein will be pub- ment ‘‘Not Preserved—Keep Refrig- lished in the FEDERAL REGISTER. Copies erated Below 40 °F. At All Times’’ un- may be purchased from the Super- less they have been thermally proc- intendent of Documents, U.S. Govern- essed to Fo 3 or more; they have been ment Printing Office, Washington, DC fermented or pickled to pH of 4.6 or 20402. It is also available for inspection less; or they have been dried to a water at the Office of the Federal Register In- activity of 0.92 or less. formation Center, 800 North Capitol

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Street NW., suite 700, Washington, DC Chapter 3 Methods of Test for Packages 20408. Labeled by Weight (b) The following NBS Handbook 133 3.11.4. Exhausting the Aerosol Container requirements are not incorporated by reference. Chapter 4 Methods of Test for Packages Labeled by Volume Chapter 2—General Considerations 4.6.4. Method D: Determining the Net Con- 2.13.1 Polyethylene Sheeting and Film tents of Compressed Gas in Cylinders 2.13.2 Textiles 4.7. Milk 2.13.3 Mulch 4.16. Fresh Oysters Labeled by Volume Chapter 5 Methods of Test for Packages La- Chapter 3—Methods of Test for Packages beled by Count, Length, Area, Thickness, Labeled by Weight or Combinations of Quantities 3.11. Aerosol Packages 5.4. Polyethylene Sheeting 3.14. Glazed Raw Seafood and Fish 3.15. Canned Coffee Supplement 3 3.16. Borax 3.17. Flour Chapter 3 Methods of Test for Packages Labeled by Weight Chapter 4—Methods of Test for Packages 3.17. Flour and Dry Pet Food Labeled by Volume 4.7. Milk Chapter 5 Methods of Test for Packages La- 4.8. Mayonnaise and Salad Dressing beled by Count, Length, Area, Thickness, or Combination of Quantities 4.9. Paint, Varnish, and Lacquers—Nonaero- sol 5.4. Polyethylene Sheeting 4.11. Peat Moss 5.5. Paper Plates 4.12. Bark Mulch 5.8. Baler Twine 4.15. Ice Cream Novelties Appendix A. Forms and Worksheets Chapter 5—Methods of Test for Packages La- Supplement 4 beled by Count, Length, Area, Thickness, 3.11 Aerosol Packages or Combinations of Quantities 3.11.1 Equipment 5.4. Polyethylene Sheeting 3.11.2 Preparation for Test 5.5. Paper Plates 3.11.3 The Determination of Net Contents: 5.6. Sanitary Paper Products Part 1 5.7. Pressed and Blown Glass Tumblers and 3.11.4 Exhausting the Aerosol Container Stemware 3.11.5 The Determination of Net Contents: Part 2 Appendix D: Package Net Contents Appendix A. Report Forms Regulations [55 FR 49834, Nov. 30, 1990, as amended at 60 D.1.1. U.S. Department of Health and FR 12884, March 9, 1995] Human Services, Food and Drug Admin- istration § 317.20 Scale requirements for accu- D.1.2. Department of Agriculture, Food rate weights, repairs, adjustments, Safety and Inspection Service and replacement after inspection. D.1.3. Federal Trade Commission D.1.4. Environmental Protection Agency (a) All scales used to weigh meat D.1.5. U.S. Department of the Treasury, Bu- products sold or otherwise distributed reau of Alcohol, Tobacco, and Firearms in commerce in federally inspected meat establishments shall be installed, (c) The following requirements of maintained and operated to insure ac- Supplement 1, dated September 1990, curate weights. Such scales shall meet Supplement 3, dated October 1992, and the applicable requirements contained Supplement 4, dated 1994, of NIST in National Institute of Standards and Handbook 133 are not incorporated by Technology Handbook 44, ‘‘Specifica- reference. tions, Tolerances and Other Technical Supplement 1 Requirements for Weighing and Meas- uring Devices,’’ 1994 Edition, October Chapter 2 General Considerations 1993, which is incorporated by ref- 2.13.1. Polyethylene Sheeting and Film erence. This incorporation was ap- 2.13.2. Textiles proved by the Director of the Federal 2.13.3. Mulch Register in accordance with 5 U.S.C..

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552(a) and 1 CFR part 51. (These mate- shall have an FSIS approved net rials are incorporated as they exist on weight program under a Total Quality the date of approval.) Copies may be Control System or Partial Quality Con- purchased from the Superintendent of trol Program in accordance with § 318.4 Documents, U.S. Government Printing of this subchapter. Office, Washington, DC 20402. It is also available for inspection at the Office of [55 FR 49834, Nov. 30, 1990] the Federal Register Information Cen- § 317.22 Handling of failed product. ter, 800 North Capitol Street NW., suite 700, Washington, DC 20408. Any lot of product which is found to (b) All scales used to weigh meat be out of compliance with net weight products sold or otherwise distributed requirements upon testing in accord- in commerce or in States designated ance with § 317.19 shall be handled as under section 301(c) of the Federal follows: Meat Inspection Act, shall be of suffi- (a) A lot tested in an official estab- cient capacity to weigh the entire unit lishment and found not to comply with and/or package. net weight requirements may be re- (c) No scale shall be used at a feder- processed and must be reweighed and ally inspected establishment to weigh remarked to satisfy the net weight re- meat products unless it has been found quirements of this section and be rein- upon test and inspection, as specified spected, in accordance with the rein NIST Handbook 44, to provide accu- quirements of this Part. rate weight. If a scale is reinspected or (b) A lot tested outside of an official retested and found to be inaccurate, or establishment and found not to comply if any repairs, adjustments or replace- with net weight requirements must be ments are made to a scale, it shall not reweighed and remarked with a proper be used until it has been inspected and net weight statement, provided that tested by a USDA official, or a State or such reweighing and remarking shall local government weights and meas- not deface, cover, or destroy any other ures official, or State registered or li- marking or labeling required under censed scale repair firm or person, and this subchapter and the net quantity of it must meet all accuracy require- contents is shown with the same prom- ments as specified in NIST Handbook inence as the most conspicuous feature 44. If a USDA inspector has put a retain of a label. tag on a scale it can only be removed [55 FR 49834, Nov. 30, 1990] by a USDA inspector. As long as the tag is on the scale, it shall not be used. § 317.23 [Reserved] [55 FR 49834, Nov. 30, 1990, as amended at 60 FR 12884, Mar. 9, 1995] § 317.24 Packaging materials. (a) Edible products may not be § 317.21 Scales: testing of. packaged in a container which is com- (a) The operator of each official es- posed in whole or in part of any poison- tablishment that weighs meat food ous or deleterious substances which products shall cause such scales to be may render the contents adulterated or tested for accuracy, in accordance with injurious to health. All packaging ma- the technical requirements of NIST terials must be safe for their intended Handbook 44, at least once during the use within the meaning of section 409 calendar year. In cases where the of the Federal Food, Drug, and Cos- scales are found not to maintain accu- metic Act, as amended (FFDCA). racy between tests, more frequent tests (b) Packaging materials entering the may be required and monitored by an official establishment must be accom- authorized USDA program official. panied or covered by a guaranty, or (b) The operator of each official es- statement of assurance, from the pack- tablishment shall display on or near aging supplier under whose brand name each scale a valid certification of the and firm name the material is mar- scale’s accuracy from a State or local keted to the official establishment. government’s weights and measures The guaranty shall state that the ma- authority or from a State registered or terial’s intended use complies with the licensed scale repair firm or person, or FFDCA and all applicable food additive

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regulations. The guaranty must iden- tion, and use. Selection of a material tify the material, e.g., by the distin- for review does not in itself affect a guishing brand name or code designa- material’s acceptability. Materials tion appearing on the packaging mate- may continue to be used during the re- rial shipping container; must specify view period. However, if information the applicable conditions of use, in- requested from the supplier is not pro- cluding temperature limits and any vided within the time indicated in the other pertinent limits specified under request—a minimum of 30 days—any the FFDCA and food additive regula- applicable guaranty shall cease to be tions; and must be signed by an author- effective, and approval to continue ized official of the supplying firm. The using the specified packaging material guaranty may be limited to a specific in official establishments may be de- shipment of an article, in which case it nied. The Administrator may extend may be part of or attached to the in- this time where reasonable grounds for voice covering such shipment, or it extension are shown, as, for example, may be general and continuing, in where data must be obtained from sup- which case, in its application to any pliers. article or other shipment of an article, it shall be considered to have been (e) The Administrator may dis- given at the date such article was approve for use in official shipped by the person who gives the establishmelts packaging materials guaranty. Guaranties consistent with whose use cannot be confirmed as com- the Food and Drug Administration’s plying with FFDCA and applicable food regulations regarding such guaranties additive regulations. Before approval (21 CFR 7.12 and 7.13) will be accept- to use a packaging material is finally able. The management of the establish- denied by the Administrator, the af- ment must maintain a file containing fected official establishment and the guaranties for all food contact packag- supplier of the material shall be given ing materials in the establishment. notice and the opportunity to present The file shall be made available to Pro- their views to the Administrator. If the gram inspectors or other Department official establishment and the supplier officials upon request. While in the of- do not accept the Administrator’s de- ficial establishment, the identity of all termination, a hearing in accordance packaging materials must be traceable with applicable rules of practice will be to the applicable guaranty. held to resolve such dispute. Approval (c) The guaranty by the packaging to use the materials pending the out- supplier will be accepted by Program come of the presentation of views or inspectors to establish that the use of hearing shall be denied if the Adminis- material complies with the FFDCA and trator determines that such use may all applicable food additive regula- present an imminent hazard to public tions. health. (d) The Department will mmnitor the (f) Periodically, the Administrator use of packaging material in official will issue to inspectors a listing, by establishments to assure that the re- distinguishing brand name or code des- quirements of paragraph (a) of this sec- ignation, of packaging materials that tion are met, and may question the basis for any guaranty described under have been reviewed and that fail to paragraph (b) of this section. Official meet the requirements of paragraph (a) establishments and packaging suppli- of this section. Listed materials will ers providing written guaranties to not be permitted for use in official es- those official establishments will be tablishments. If a subsequent review of permitted an opportunity to provide any material indicates that it meets information tm designated Department the requirements of paragraph (a), the officials as needed to verify the basis material will be deleted from the list- for any such guaranty. The required in- ing. formation will include, but is not lim- (g) Nothing in this section shall af- ited to, manufacturing firm’s name, fect the authority of Program inspec- trade name or code designation for the tors to refuse a specific material if he/ material, complete chemical composi- she determines the material may

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render products adulterated or injuri- trition information. In determining the ous to health. sufficiency of available space for the nutrition information, the space need- [49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990] ed for vignettes, designs, and other nonmandatory label information on the principal display panel may be con- Subpart B—Nutrition Labeling sidered.

SOURCE: 58 FR 664, Jan. 6, 1993, unless oth- [58 FR 664, Jan. 6, 1993, as amended at 59 FR erwise noted. 40213, Aug. 8, 1994; 60 FR 176, Jan. 3, 1995]

§ 317.300 Nutrition labeling of meat or §§ 317.303–317.307 [Reserved] meat food products. § 317.308 Labeling of meat or meat (a) Nutrition labeling shall be pro- food products with number of vided for all meat or meat food prod- servings. ucts intended for human consumption The label of any package of a meat or and offered for sale, except single-in- meat food product that bears a rep- gredient, raw products, in accordance resentation as to the number of with the requirements of § 317.309; ex- servings contained in such package cept as exempted under § 317.400 of this shall meet the requirements of subpart. (b) Nutrition labeling may be pro- § 317.2(h)(10). vided for single-ingredient, raw meat [58 FR 664, Jan. 6, 1993, as amended at 60 FR or meat food products in accordance 176, Jan. 3, 1995] with the requirements of §§ 317.309 and 317.345. Significant participation in vol- § 317.309 Nutrition label content. untary nutrition labeling shall be (a) All nutrient and food component measured by the Agency in accordance quantities shall be declared in relation with §§ 317.343 and 317.344 of this sub- to a serving as defined in this section. part. (b)(1) The term ‘‘serving’’ or ‘‘serving size’’ means an amount of food cus- [58 FR 664, Jan. 6, 1993, as amended at 60 FR 176, Jan. 3, 1995] tomarily consumed per eating occasion by persons 4 years of age or older, § 317.301 [Reserved] which is expressed in a common household measure that is appropriate to the § 317.302 Location of nutrition infor- product. When the product is specially mation. formulated or processed for use by in- (a) Nutrition information on a label fants or by toddlers, a serving or serv- of a packaged meat or meat food prod- ing size means an amount of food cus- uct shall appear on the label’s principal tomarily consumed per eating occasion display panel or on the information by infants up to 12 months of age or by panel, except as provided in paragraphs children 1 through 3 years of age, re- (b) and (c) of this section. spectively. (b) Nutrition information for gift (2) Except as provided in paragraphs packs may be shown at a location (b)(8), (b)(12), and (b)(14) of this section other than on the product label, pro- and for products that are intended for vided that the labels for these products weight control and are available only bear no nutrition claim. In lieu of on through a weight-control or weight- the product label, nutrition informa- maintenance program, serving size de- tion may be provided by alternate clared on a product label shall be deter- means such as product label inserts. mined from the ‘‘Reference Amounts (c) Meat or meat food products in Customarily Consumed Per Eating Oc- packages that have a total surface area casion—General Food Supply’’ (Ref- available to bear labeling greater than erence Amount(s)) that appear in 40 square inches but whose principal § 317.312(b) using the procedures de- display panel and information panel do scribed in this paragraph (b). For prod- not provide sufficient space to accom- ucts that are both intended for weight modate all required information may control and available only through a use any alternate panel that can be weight-control program, a manufac- readily seen by consumers for the nu- turer may determine the serving size

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that is consistent with the meal plan of (v) For products that have Reference the program. Such products must bear Amounts of 100 grams (or milliliter) or a statement, ‘‘for sale only through the larger and are individual units within a lll program’’ (fill in the blank with multi-serving package, if a unit con- the name of the appropriate weight- tains more than 150 percent but less control program, e.g., Smith’s Weight than 200 percent of the Reference Control), on the principal display Amount, the manufacturer may decide panel. However, the Reference whether to declare the individual unit Amounts in § 317.312(b) shall be used for as 1 or 2 servings. purposes of evaluating whether weight- (vi) For products which consist of control products that are available two or more foods packaged and pre- only through a weight-control program sented to be consumed together where qualify for nutrition claims. the ingredient represented as the main (3) The declaration of nutrient and ingredient is in discrete units (e.g., food component content shall be on the beef fritters and barbecue sauce), the basis of the product ‘‘as packaged’’ for serving size may be the number of dis- all products, except that single-ingre- crete units represented as the main in- dient, raw products may be declared on gredient plus proportioned minor in- the basis of the product ‘‘as consumed’’ gredients used to make the Reference as set forth in § 317.345(a)(1). In addition Amount for the combined product as to the required declaration on the basis determined in § 317.312(c). of ‘‘as packaged’’ for products other (vii) For packages containing several than single-ingredient, raw products, individual single-serving containers, the declaration may also be made on each of which is labeled with all re- the basis of ‘‘as consumed,’’ provided that preparation and cooking instruc- quired information including nutrition tions are clearly stated. labeling as specified in this section (4) For products in discrete units (i.e., are labeled appropriately for indi- (e.g., hot dogs, and individually vidual sale as single-serving contain- packaged products within a multi-serv- ers), the serving size shall be 1 unit. ing package), and for products which (5) For products in large discrete consist of two or more foods packaged units that are usually divided for con- and presented to be consumed together sumption (e.g., pizza), for unprepared where the ingredient represented as the products where the entire contents of main ingredient is in discrete units the package is used to prepare large (e.g., beef fritters and barbecue sauce), discrete units that are usually divided the serving size shall be declared as fol- for consumption (e.g. pizza kit), and for lows: products which consist of two or more (i) If a unit weighs 50 percent or less foods packaged and presented to be of the Reference Amount, the serving consumed together where the ingredi- size shall be the number of whole units ent represented as the main ingredient that most closely approximates the is a large discrete unit usually divided Reference Amount for the product cat- for consumption, the serving size shall egory. be the fractional slice of the ready-to- (ii) If a unit weighs more than 50 per- eat product (e.g., 1⁄8 quiche, 1⁄4 pizza) cent but less than 67 percent of the that most closely approximates the Reference Amount, the manufacturer Reference Amount for the product cat- may declare one unit or two units as egory. The serving size may be the the serving size. fraction of the package used to make (iii) If a unit weighs 67 percent or the Reference Amount for the unpre- more but less than 200 percent of the pared product determined in § 317.312(d) Reference Amount, the serving size or the fraction of the large discrete shall be one unit. unit represented as the main ingredi- (iv) If a unit weighs 200 percent or ent plus proportioned minor ingredi- more of the Reference Amount, the ents used to make the Reference manufacturer may declare one unit as Amount of the combined product deter- the serving size if the whole unit can mined in § 317.312(c). In expressing the reasonably be consumed at a single fractional slice, manufacturers shall eating occasion. use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions

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that can be generated by further divi- (iv) A description of the individual sion by 2 or 3. container or package shall be used for (6) For nondiscrete bulk products single-serving containers and meal- (e.g., whole roast beef, marinated beef type products and for individually tenderloin, large can of chili), and for packaged products within multi-serv- products which consist of two or more ing containers (e.g., can, box, package, foods packaged and presented to be meal, or dinner). A description of the consumed together where the ingredi- individual unit shall be used for other ent represented as the main ingredient products in discrete units (e.g., chop, is a bulk product (e.g., roast beef and slice, link, or patty). gravy), the serving size shall be the (v) For unprepared products where amount in household measure that the entire contents of the package is most closely approximates the Ref- used to prepare large discrete units erence Amount for the product cat- that are usually divided for consump- egory and may be the amount of the tion (e.g., pizza kit), the fraction or bulk product represented as the main portion of the package may be used. ingredient plus proportioned minor in- (vi) For products that consist of two gredients used to make the Reference or more distinct ingredients or compo- Amount for the combined product de- nents packaged and presented to be termined in § 317.312(c). consumed together (e.g., ham with a (7) For labeling purposes, the term glaze packet), the nutrition informa- ‘‘common household measure’’ or tion may be declared for each compo- ‘‘common household unit’’ means cup, nent or as a composite. The serving tablespoon, teaspoon, piece, slice, frac- size may be provided in accordance 1 tion (e.g., ⁄4 pizza), ounce (oz), or other with the provisions of paragraphs common household equipment used to (b)(4), (b)(5), and (b)(6) of this section. package food products (e.g., jar or (vii) For nutrition labeling purposes, tray). In expressing serving size in a teaspoon means 5 milliliters (mL), a household measures, except as speci- tablespoon means 15 mL, a cup means fied in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following rules 240 mL, and 1 oz in weight means 28 shall be used: grams (g). (i) Cups, tablespoons, or teaspoons (viii) When a serving size, determined shall be used wherever possible and ap- from the Reference Amount in § 317.312(b) and the procedures described propriate. Cups shall be expressed in 1⁄4- in this section, falls exactly half way or 1⁄3-cup increments, tablespoons in whole number of tablespoons for quan- between two serving sizes (e.g., 2.5 tities less than 1⁄4 cup but greater than tbsp), manufacturers shall round the or equal to 2 tablespoons (tbsp), 1, 11⁄3, serving size up to the next incremental 11⁄2, or 1 2⁄3 tbsp for quantities less than size. 2 tbsp but greater than or equal to 1 (8) A product that is packaged and tbsp, and teaspoons in whole number of sold individually and that contains less teaspoons for quantities less than 1 than 200 percent of the applicable Ref- tbsp but greater than or equal to 1 tea- erence Amount shall be considered to spoon (tsp), and in 1⁄4-tsp increments be a single-serving container, and the for quantities less than 1 tsp. entire content of the product shall be (ii) If cups, tablespoons or teaspoons labeled as one serving, except for prod- are not applicable, units such as piece, ucts that have Reference Amounts of slice, tray, jar, and fraction shall be 100 g (or mL) or larger, manufacturers used. may decide whether a package that (iii) If cups, tablespoons and contains more than 150 percent but less teaspoons, or units such as piece, slice, than 200 percent of the Reference tray, jar, or fraction are not applicable, Amount is 1 or 2 servings. Packages ounces may be used. Ounce measure- sold individually that contain 200 per- ments shall be expressed in 0.5-ounce cent or more of the applicable Ref- increments most closely approximat- erence Amount may be labeled as a sin- ing the Reference Amount with round- gle-serving if the entire content of the ing indicated by the use of the term package can reasonably be consumed ‘‘about’’ (e.g., about 2.5 ounces). at a single-eating occasion.

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(9) A label statement regarding a tween 2 and 5 servings and random serving shall be the serving size ex- weight products. The number of pressed in common household measures servings between 2 and 5 servings shall as set forth in paragraphs (b)(2) be rounded to the nearest 0.5 serving. through (b)(8) of this section and shall Rounding should be indicated by the be followed by the equivalent metric use of the term ‘‘about’’ (e.g., about 2 quantity in parenthesis (fluids in milli- servings; about 3.5 servings). liters and all other foods in grams), ex- (ii) When the serving size is required cept for single-serving containers. to be expressed on a drained solids (i) For a single-serving container, the basis and the number of servings varies parenthetical metric quantity, which because of a natural variation in unit will be presented as part of the net size (e.g., pickled pigs feet), the manu- weight statement on the principal dis- facturer may state the typical number play panel, is not required except of servings per container (e.g., usually where nutrition information is re- 5 servings). quired on a drained weight basis ac- (iii) For random weight products, a cording to paragraph (b)(11) of this sec- manufacturer may declare ‘‘varied’’ for tion. However, if a manufacturer vol- the number of servings per container untarily provides the metric quantity provided the nutrition information is on products that can be sold as single- based on the Reference Amount ex- servings, then the numerical value pro- pressed in ounces. The manufacturer vided as part of the serving size dec- may provide the typical number of laration must be identical to the met- servings in parenthesis following the ric quantity declaration provided as ‘‘varied’’ statement (e.g., varied (ap- part of the net quantity of contents proximately 8 servings per pound)). statement. (iv) For packages containing several (ii) The gram or milliliter quantity individual single-serving containers, equivalent to the household measure each of which is labeled with all re- should be rounded to the nearest whole quired information including nutrition number except for quantities that are less than 5 g (mL). The gram (mL) labeling as specified in this section quantity between 2 and 5 g (mL) should (i.e., are labeled appropriately for indi- be rounded to the nearest 0.5 g (mL) vidual sale as single-serving contain- and the g (mL) quantity less than 2 g ers), the number of servings shall be (mL) should be expressed in 0.1-g (mL) the number of individual packages increments. within the total package. (iii) In addition, serving size may be (v) For packages containing several declared in ounce, in parenthesis, fol- individually packaged multi-serving lowing the metric measure separated units, the number of servings shall be by a slash where other common house- determined by multiplying the number hold measures are used as the primary of individual multi-serving units in the unit for serving size, e.g., 1 slice (28 g/ total package by the number of 1 oz) for sliced bologna. The ounce servings in each individual unit. quantity equivalent to the metric (11) The declaration of nutrient and quantity should be expressed in 0.1-oz food component content shall be on the increments. basis of product as packaged or pur- (iv) If a manufacturer elects to use chased with the exception of products abbreviations for units, the following that are packed or canned in water, abbreviations shall be used: tbsp for ta- brine, or oil but whose liquid packing blespoon, tsp for teaspoon, g for gram, medium is not customarily consumed. mL for milliliter, and oz for ounce. Declaration of the nutrient and food (10) Determination of the number of component content of products that servings per container shall be based are packed in liquid which is not cus- on the serving size of the product de- tomarily consumed shall be based on termined by following the procedures the drained solids. described in this section. (12) Serving size for meal-type prod- (i) The number of servings shall be ucts as defined in § 317.313(l) shall be rounded to the nearest whole number the entire content (edible portion only) except for the number of servings be- of the package.

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(13) Another column of figures may pressed to the nearest 5-calorie incre- be used to declare the nutrient and ment up to and including 50 calories, food component information in the and 10-calorie increment above 50 cal- same format as required by § 317.309(e), ories, except that amounts less than 5 (i) Per 100 grams, 100 milliliters, or 1 calories may be expressed as zero. En- ounce of the product as packaged or ergy content per serving may also be purchased. expressed in kilojoule units, added in (ii) Per one unit if the serving size of parenthesis immediately following the a product in discrete units in a multi- statement of the caloric content. serving container is more than one (i) Caloric content may be calculated unit. by the following methods. Where either (14) If a product consists of assort- specific or general food factors are ments of meat or meat food products used, the factors shall be applied to the (e.g., variety packs) in the same pack- actual amount (i.e., before rounding) of age, nutrient content shall be ex- food components (e.g., fat, carbo- pressed on the entire package contents hydrate, protein, or ingredients with or on each individual product. specific food factors) present per serv- (15) If a product is commonly coming. bined with other ingredients or is (A) Using specific Atwater factors cooked or otherwise prepared before (i.e., the Atwater method) given in eating, and directions for such com- Table 13, page 25, ‘‘Energy Value of bination or preparations are provided, Foods—Basis and Derivation,’’ by A. L. another column of figures may be used Merrill and B. K. Watt, United States to declare the nutrient contents on the Department of Agriculture (USDA), basis of the product as consumed for Agriculture Handbook No. 74 (Slightly the product alone (e.g., a cream soup revised February 1973), which is incor- mix may be labeled with one set of porated by reference. Table 13 of the Daily Values for the dry mix (per serv- ‘‘Energy Value of Foods—Basis and ing), and another set for the serving of Derivation,’’ Agriculture Handbook No. the final soup when prepared (e.g., per 74 is incorporated as it exists on the serving of cream soup mix and 1 cup of date of approval. This incorporation by vitamin D fortified whole milk)): Pro- reference was approved by the Director vided, That the type and quantity of of the Federal Register in accordance the other ingredients to be added to with 5 U.S.C. 552(a) and 1 CFR part 51. the product by the user and the specific It is available for inspection at the Of- method of cooking and other prepara- fice of the Federal Register, suite 700, tion shall be specified prominently on 800 North Capitol Street, NW., Wash- the label. ington, DC, or at the office of the FSIS (c) The declaration of nutrition infor- Docket Clerk, Room 3171, South Build- mation on the label or in labeling of a ing, 14th and Independence Avenue, meat or meat food product shall con- SW., Washington, DC. Copies of the in- tain information about the level of the corporation by reference are available following nutrients, except for those from the Product Assessment Division, nutrients whose inclusion, and the dec- Regulatory Programs, Food Safety and laration of amounts, is voluntary as Inspection Service, U.S. Department of set forth in this paragraph. No nutri- Agriculture, Room 329, West End Court ents or food components other than Building, Washington, DC 20250–3700; those listed in this paragraph as either (B) Using the general factors of 4, 4, mandatory or voluntary may be in- and 9 calories per gram for protein, cluded within the nutrition label. Ex- total carbohydrate, and total fat, re- cept as provided for in paragraph (f) or spectively, as described in USDA’s Ag- (g) of this section, nutrient informa- riculture Handbook No. 74 (Slightly re- tion shall be presented using the nutri- vised February 1973), pages 9–11, which ent names specified and in the follow- is incorporated by reference. Pages 9– ing order in the formats specified in 11, Agriculture Handbook No. 74 is in- paragraph (d) or (e) of this section. corporated as it exists on the date of (1) ‘‘Calories, total,’’ ‘‘Total cal- approval. This incorporation by ref- ories,’’ or ‘‘Calories’’: A statement of erence was approved by the Director of the caloric content per serving, ex- the Federal Register in accordance

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with 5 U.S.C. 552(a) and 1 CFR part 51. crement below 5 grams and to the near- (The availability of this incorporation est gram increment above 5 grams. If by reference is given in paragraph the serving contains less than 0.5 gram, (c)(1)(i)(A) of this section.); the content shall be expressed as zero. (C) Using the general factors of 4, 4, (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A and 9 calories per gram for protein, statement of the number of grams of total carbohydrate less the amount of saturated fat per serving defined as the insoluble dietary fiber, and total fat, sum of all fatty acids containing no respectively, as described in USDA’s double bonds, except that label dec- Agriculture Handbook No. 74 (Slightly laration of saturated fat content infor- revised February 1973), pages 9–11, mation is not required for products which is incorporated by reference in that contain less than 0.5 gram of total accordance with 5 U.S.C. 552(a) and 1 fat per serving if no claims are made CFR part 51. (The availability of this about fat or cholesterol content, and if incorporation by reference is given in ‘‘calories from saturated fat’’ is not de- paragraph (c)(1)(i)(A) of this section.); clared. Saturated fat content shall be or indented and expressed as grams per (D) Using data for specific food fac- serving to the nearest 0.5 (1⁄2)-gram in- tors for particular foods or ingredients crement below 5 grams and to the near- approved by the Food and Drug Admin- est gram increment above 5 grams. If istration (FDA) and provided in parts the serving contains less than 0.5 gram, 172 or 184 of 21 CFR, or by other means, the content shall be expressed as zero. as appropriate. (A) ‘‘Stearic Acid’’ (VOLUNTARY): A (ii) ‘‘Calories from fat’’: A statement statement of the number of grams of of the caloric content derived from stearic acid per serving may be de- total fat as defined in paragraph (c)(2) clared voluntarily, except that when a of this section per serving, expressed to claim is made about stearic acid, label the nearest 5-calorie increment, up to declaration shall be required. Stearic and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when section per serving may be declared monounsaturated fat is declared, or voluntarily, expressed to the nearest 5- when a claim about fatty acids or cho- calorie increment, up to and including lesterol is made on the label or in la- 50 calories, and the nearest 10-calorie beling of a product other than one that increment above 50 calories, except meets the criteria in § 317.362(b)(1) for a that amounts less than 5 calories may claim for ‘‘fat free,’’ label declaration be expressed as zero. This statement of polyunsaturated fat is required. shall be indented under the statement Polyunsaturated fat content shall be of calories from fat as provided in para- indented and expressed as grams per graph (d)(5) of this section. serving to the nearest 0.5 (1⁄2)-gram in- (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A crement below 5 grams and to the near- statement of the number of grams of est gram increment above 5 grams. If total fat per serving defined as total the serving contains less than 0.5 gram, lipid fatty acids and expressed as the content shall be expressed as zero. triglycerides. Amounts shall be ex- (iii) ‘‘Monounsaturated fat’’ or pressed to the nearest 0.5 (1⁄2)-gram in- ‘‘Monounsaturated’’ (VOLUNTARY): A

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statement of the number of grams of (6) ‘‘Carbohydrate, total’’ or ‘‘Total monounsaturated fat per serving de- carbohydrate’’: A statement of the fined as cis-monounsaturated fatty number of grams of total carbohydrate acids may be declared voluntarily, ex- per serving expressed to the nearest cept that when polyunsaturated fat is gram, except that if a serving contains declared, or when a claim about fatty less than 1 gram, the statement ‘‘Con- acids or cholesterol is made on the tains less than 1 gram’’ or ‘‘less than 1 label or in labeling of a product other gram’’ may be used as an alternative, than one that meets the criteria in or, if the serving contains less than 0.5 § 317.362(b)(1) for a claim for ‘‘fat free,’’ gram, the content may be expressed as label declaration of monounsaturated zero. Total carbohydrate content shall fat is required. Monounsaturated fat be calculated by subtraction of the sum content shall be indented and expressed of the crude protein, total fat, mois- as grams per serving to the nearest 0.5 ture, and ash from the total weight of (1⁄2)-gram increment below 5 grams and the product. This calculation method is to the nearest gram increment above 5 described in USDA’s Agriculture Hand- grams. If the serving contains less than book No. 74 (Slightly revised February 0.5 gram, the content shall be expressed 1973), pages 2 and 3, which is incor- as zero. porated by reference. Pages 2 and 3, Ag- (3) ‘‘Cholesterol’’: A statement of the riculture Handbook No. 74 is incor- cholesterol content per serving ex- porated as it exists on the date of ap- pressed in milligrams to the nearest 5- proval. This incorporation by reference milligram increment, except that label was approved by the Director of the declaration of cholesterol information Federal Register in accordance with 5 is not required for products that con- U.S.C. 552(a) and 1 CFR part 51. (The tain less than 2 milligrams of choles- availability of this incorporation by terol per serving and make no claim reference is given in paragraph about fat, fatty acids, or cholesterol (c)(1)(i)(A) of this section.) content, or such products may state (i) ‘‘Dietary fiber’’: A statement of the cholesterol content as zero. If the the number of grams of total dietary product contains 2 to 5 milligrams of fiber per serving, indented and ex- cholesterol per serving, the content pressed to the nearest gram, except may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of the serving contains greater than 140 soluble dietary fiber per serving may milligrams. be declared voluntarily except when a (5) ‘‘Potassium’’ (VOLUNTARY): A claim is made on the label or in label- statement of the number of milligrams ing about soluble fiber, label declara- of potassium per serving may be de- tion shall be required. Soluble fiber clared voluntarily, except that when a content shall be indented under dietary claim is made about potassium con- fiber and expressed to the nearest tent, label declaration shall be re- gram, except that if a serving contains quired. Potassium content shall be ex- less than 1 gram, the statement ‘‘Con- pressed as zero when the serving contains less than 1 gram’’ or ‘‘less than 1 tains less than 5 milligrams of potas- gram’’ may be used as an alternative, sium, to the nearest 5-milligram incre- and if the serving contains less than 0.5 ment when the serving contains 5 to gram, the content may be expressed as 140 milligrams of potassium, and to the zero. nearest 10-milligram increment when (B) ‘‘Insoluble fiber’’ (VOLUNTARY): the serving contains greater than 140 A statement of the number of grams of milligrams. insoluble dietary fiber per serving may

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be declared voluntarily except when a alternative, and if the serving contains claim is made on the label or in label- less than 0.5 gram, the content may be ing about insoluble fiber, label declara- expressed as zero. tion shall be required. Insoluble fiber (iv) ‘‘Other carbohydrate’’ (VOL- content shall be indented under dietary UNTARY): A statement of the number fiber and expressed to the nearest of grams of other carbohydrate per gram, except that if a serving contains serving may be declared voluntarily. less than 1 gram, the statement ‘‘Con- Other carbohydrate shall be defined as tains less than 1 gram’’ or ‘‘less than 1 the difference between total carbo- gram’’ may be used as an alternative, hydrate and the sum of dietary fiber, and if the serving contains less than 0.5 sugars, and sugar alcohol, except that gram, the content may be expressed as if sugar alcohol is not declared (even if zero. present), it shall be defined as the dif- (ii) ‘‘Sugars’’: A statement of the ference between total carbohydrate and number of grams of sugars per serving, the sum of dietary fiber and sugars. except that label declaration of sugars Other carbohydrate content shall be in- content is not required for products dented and expressed to the nearest that contain less than 1 gram of sugars gram, except that if a serving contains per serving if no claims are made about less than 1 gram, the statement ‘‘Con- sweeteners, sugars, or sugar alcohol tains less than 1 gram’’ or ‘‘less than 1 content. Sugars shall be defined as the gram’’ may be used as an alternative, sum of all free mono- and disaccharides and if the serving contains less than 0.5 (such as glucose, fructose, lactose, and gram, the content may be expressed as sucrose). Sugars content shall be in- zero. dented and expressed to the nearest (7) ‘‘Protein’’: A statement of the gram, except that if a serving contains number of grams of protein per serving less than 1 gram, the statement ‘‘Con- expressed to the nearest gram, except tains less than 1 gram’’ or ‘‘less than 1 that if a serving contains less than 1 gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected tone or aldehyde group and whose use amino acid score of less than 40 ex- in the food is listed by FDA (e.g., pressed as a percent, either of the fol- mannitol or xylitol) or is generally rec- lowing shall be placed adjacent to the ognized as safe (e.g., sorbitol). In lieu declaration of protein content by of the term ‘‘sugar alcohol,’’ the name weight: The statement ‘‘not a signifi- of the specific sugar alcohol (e.g., cant source of protein,’’ or a listing ‘‘xylitol’’) present in the product may aligned under the column headed ‘‘Per- be used in the nutrition label, provided cent Daily Value’’ of the corrected that only one sugar alcohol is present amount of protein per serving, as de- in the product. Sugar alcohol content termined in paragraph (c)(7)(ii) of this shall be indented and expressed to the section, calculated as a percentage of nearest gram, except that if a serving the Daily Reference Value (DRV) or contains less than 1 gram, the state- Reference Daily Intake (RDI), as appro- ment ‘‘Contains less then 1 gram’’ or priate, for protein and expressed as per- ‘‘less than 1 gram’’ may be used as an cent of Daily Value. When the protein

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quality in a product as measured by by the Food and Agriculture Organiza- the Protein Efficiency Ratio (PER) is tion of the United Nations/World less than 40 percent of the reference Health Organization, is incorporated as standard (casein) for a product rep- it exists on the date of approval. This resented or purported to be for infants, incorporation by reference was ap- the statement ‘‘not a significant source proved by the Director of the Federal of protein’’ shall be placed adjacent to Register in accordance with 5 U.S.C. the declaration of protein content. Pro- 552(a) and 1 CFR part 51. It is available tein content may be calculated on the for inspection at the Office of the Fed- basis of the factor of 6.25 times the ni- eral Register, suite 700, 800 North Cap- trogen content of the food as deter- itol Street, NW., Washington, DC, or at mined by appropriate methods of anal- the office of the FSIS Docket Clerk, ysis in accordance with § 317.309(h), ex- Room 3171, South Building, 14th and cept when the procedure for a specific Independence Avenue, SW., Washing- food requires another factor. ton, DC. Copies of the incorporation by (i) A statement of the corrected reference are available from the Prod- amount of protein per serving, as de- uct Assessment Division, Regulatory termined in paragraph (c)(7)(ii) of this Programs, Food Safety and Inspection section, calculated as a percentage of Service, U.S. Department of Agri- the RDI or DRV for protein, as appro- culture, Room 329, West End Court priate, and expressed as percent of Building, Washington, DC 20250–3700. Daily Value, may be placed on the For products represented or purported label, except that such a statement to be for infants, the corrected amount shall be given if a protein claim is of protein (grams) per serving is equal made for the product, or if the product to the actual amount of protein is represented or purported to be for in- (grams) per serving multiplied by the fants or children under 4 years of age. relative protein quality value. The rel- When such a declaration is provided, it ative protein quality value shall be de- shall be placed on the label adjacent to termined by dividing the subject prod- the statement of grams of protein and uct’s protein PER value by the PER aligned under the column headed ‘‘Per- value for casein. If the relative protein cent Daily Value,’’ and expressed to value is above 1.00, it shall be set at the nearest whole percent. However, 1.00. the percentage of the RDI for protein shall not be declared if the product is (iii) For the purpose of labeling with represented or purported to be for in- a percent of the DRV or RDI, a value of fants and the protein quality value is 50 grams of protein shall be the DRV less than 40 percent of the reference for adults and children 4 or more years standard. of age, and the RDI for protein for chil- (ii) The corrected amount of protein dren less than 4 years of age, infants, (grams) per serving for products rep- pregnant women, and lactating women resented or purported to be for adults shall be 16 grams, 14 grams, 60 grams, and children 1 or more years of age is and 65 grams, respectively. equal to the actual amount of protein (8) Vitamins and minerals: A state- (grams) per serving multiplied by the ment of the amount per serving of the amino acid score corrected for protein vitamins and minerals as described in digestibility. If the corrected score is this paragraph, calculated as a percent above 1.00, then it shall be set at 1.00. of the RDI and expressed as percent of The protein digestibility-corrected Daily Value. amino acid score shall be determined (i) For purposes of declaration of per- by methods given in sections 5.4.1, 7.2.1, cent of Daily Value as provided for in and 8 in ‘‘Protein Quality Evaluation, paragraphs (d) through (g) of this sec- Report of the Joint FAO/WHO Expert tion, products represented or purported Consultation on Protein Quality Eval- to be for use by infants, children less uation,’’ Rome, 1990, which is incor- than 4 years of age, pregnant women, porated by reference. Sections 5.4.1, or lactating women shall use the RDI’s 7.2.1, and 8 of the ‘‘Report of the Joint that are specified for the intended FAO/WHO Expert Consultation on Pro- group. For products represented or pur- tein Quality Evaluation,’’ as published ported to be for use by both infants and

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children under 4 years of age, the per- erals present at less than 2 percent of cent of Daily Value shall be presented the RDI are not required to be declared by separate declarations according to in nutrition labeling but may be de- paragraph (e) of this section based on clared by a zero or by the use of an as- the RDI values for infants from birth terisk (or other symbol) that refers to to 12 months of age and for children another asterisk (or symbol) that is under 4 years of age. Similarly, the placed at the bottom of the table and percent of Daily Value based on both that is followed by the statement the RDI values for pregnant women ‘‘Contains less than 2 percent of the and for lactating women shall be de- Daily Value of this (these) nutrient clared separately on products rep- (nutrients).’’ Alternatively, if vitamin resented or purported to be for use by A, vitamin C, calcium, or iron is both pregnant and lactating women. present in amounts less than 2 percent When such dual declaration is used on of the RDI, label declaration of the nu- any label, it shall be included in all la- trient(s) is not required if the state- beling, and equal prominence shall be ment ‘‘Not a significant source of given to both values in all such label- lll (listing the vitamins or minerals ing. All other products shall use the omitted)’’ is placed at the bottom of RDI for adults and children 4 or more the table of nutrient values. years of age. (iv) The following RDI’s and nomen- (ii) The declaration of vitamins and clature are established for the follow- minerals as a percent of the RDI shall ing vitamins and minerals which are include vitamin A, vitamin C, calcium, essential in human nutrition: and iron, in that order, and shall in- Vitamin A, 5,000 International Units clude any of the other vitamins and Vitamin C, 60 milligrams minerals listed in paragraph (c)(8)(iv) Calcium, 1.0 gram of this section when they are added, or Iron, 18 milligrams when a claim is made about them. Vitamin D, 400 International Units Other vitamins and minerals need not Vitamin E, 30 International Units be declared if neither the nutrient nor Thiamin, 1.5 milligrams the component is otherwise referred to Riboflavin, 1.7 milligrams on the label or in labeling or advertis- Niacin, 20 milligrams ing and the vitamins and minerals are: Vitamin B6, 2.0 milligrams (A) Required or permitted in a stand- Folate, 0.4 milligram ardized food (e.g., thiamin, riboflavin, Vitamin B12, 6 micrograms and niacin in enriched flour) and that Biotin, 0.3 milligram standardized food is included as an in- Pantothenic acid, 10 milligrams gredient (i.e., component) in another Phosphorus, 1.0 gram product; or Iodine, 150 micrograms (B) Included in a product solely for Magnesium, 400 milligrams technological purposes and declared Zinc, 15 milligrams only in the ingredients statement. The Copper, 2.0 milligrams declaration may also include any of the (v) The following synonyms may be other vitamins and minerals listed in added in parenthesis immediately fol- paragraph (c)(8)(iv) of this section lowing the name of the nutrient or die- when they are naturally occurring in tary component: the food. The additional vitamins and Vitamin C—Ascorbic acid minerals shall be listed in the order es- Thiamin—Vitamin B1 tablished in paragraph (c)(8)(iv) of this Riboflavin—Vitamin B2 section. Folate—Folacin (iii) The percentages for vitamins Calories—Energy and minerals shall be expressed to the (vi) A statement of the percent of vi- nearest 2-percent increment up to and tamin A that is present as beta-caro- including the 10-percent level, the tene may be declared voluntarily. nearest 5-percent increment above 10 When the vitamins and minerals are percent and up to and including the 50- listed in a single column, the state- percent level, and the nearest 10-per- ment shall be indented under the infor- cent increment above the 50-percent mation on vitamin A. When vitamins level. Amounts of vitamins and min- and minerals are arrayed horizontally,

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the statement of percent shall be pre- (iii) Information required in para- sented in parenthesis following the dec- graphs (d)(3), (d)(5), (d)(7), and (d)(8) of laration of vitamin A and the percent this section shall be in type size no of Daily Value of vitamin A in the smaller than 8 point. Except for the product (e.g., ‘‘Percent Daily Value: heading ‘‘Nutrition Facts,’’ the infor- Vitamin A 50 (90 percent as beta-caro- mation required in paragraphs (d)(4), tene)’’). When declared, the percent- (d)(6), and (d)(9) of this section and all ages shall be expressed in the same in- other information contained within the crements as are provided for vitamins nutrition label shall be in type size no and minerals in paragraph (c)(8)(iii) of smaller than 6 point. When provided, this section. the information described in paragraph (9) For the purpose of labeling with a (d)(10) of this section shall also be in percent of the DRV, the following type no smaller than 6 point. DRV’s are established for the following (iv) The headings required by para- food components based on the reference graphs (d)(2), (d)(4), and (d)(6) of this caloric intake of 2,000 calories: section (i.e., ‘‘Nutrition Facts,’’ Food component Unit of measurement DRV ‘‘Amount per Serving,’’ and ‘‘% Daily Value*’’), the names of all nutrients Fat ...... grams (g) ...... 65 that are not indented according to re- Saturated fatty acids ...... do ...... 20 Cholesterol ...... milligrams (mg) ...... 300 quirements of paragraph (c) of this sec- Total carbohydrate ...... grams (g) ...... 300 tion (i.e., Calories, Total fat, Choles- Fiber ...... do ...... 25 terol, Sodium, Potassium, Total carbo- Sodium ...... milligrams (mg) ...... 2,400 Potassium ...... do ...... 3,500 hydrate, and Protein), and the percent- Protein ...... grams (g) ...... 50 age amounts required by paragraph (d)(7)(ii) of this section shall be high- (d)(1) Nutrient information specified lighted by bold or extra bold type or in paragraph (c) of this section shall be other highlighting (reverse printing is presented on products in the following not permitted as a form of highlight- format, except on products on which ing) that prominently distinguishes it dual columns of nutrition information from other information. No other infor- are declared as provided for in para- mation shall be highlighted. graph (e) of this section, on those prod- (v) A hairline rule that is centered ucts on which the simplified format is between the lines of text shall separate permitted to be used as provided for in ‘‘Amount Per Serving’’ from the cal- paragraph (f) of this section, on prod- orie statements required in paragraph ucts for infants and children less than (d)(5) of this section and shall separate 4 years of age as provided for in each nutrient and its corresponding § 317.400(c), and on products in packages percent of Daily Value required in that have a total surface area available paragraphs (d)(7)(i) and (d)(7)(ii) of this to bear labeling of 40 or less square section from the nutrient and percent inches as provided for in paragraph (g) of Daily Value above and below it. of this section. (i) The nutrition information shall be (2) The information shall be pre- set off in a box by use of hairlines and sented under the identifying heading of shall be all black or one color type, ‘‘Nutrition Facts’’ which shall be set in printed on a white or other neutral a type size larger than all other print contrasting background whenever prac- size in the nutrition label and, except tical. for labels presented according to the (ii) All information within the nutri- format provided for in paragraph (d)(11) tion label shall utilize: of this section, unless impractical, (A) A single easy-to-read type style, shall be set the full width of the infor- (B) Upper and lower case letters, mation provided under paragraph (d)(7) (C) At least one point leading (i.e., of this section. space between two lines of text) except (3) Information on serving size shall that at least four points leading shall immediately follow the heading. Such be utilized for the information required information shall include: by paragraphs (d)(7) and (d)(8) of this (i) ‘‘Serving Size’’: A statement of section, and the serving size as specified in para- (D) Letters should never touch. graph (b)(9) of this section.

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(ii) ‘‘Servings Per Container’’: The a DRV has been established, except number of servings per container, ex- that the percent for protein may be cept that this statement is not re- omitted as provided in paragraph (c)(7) quired on single-serving containers as of this section. The percent shall be defined in paragraph (b)(8) of this sec- calculated by dividing either the tion. amount declared on the label for each (4) A subheading ‘‘Amount Per Serv- nutrient or the actual amount of each ing’’ shall be separated from serving nutrient (i.e., before rounding) by the size information by a bar. DRV for the nutrient, except that the (5) Information on calories shall im- percent for protein shall be calculated mediately follow the heading ‘‘Amount as specified in paragraph (c)(7)(ii) of Per Serving’’ and shall be declared in this section. The numerical value shall one line, leaving sufficient space be- be followed by the symbol for percent tween the declaration of ‘‘Calories’’ and ‘‘Calories from fat’’ to allow clear (i.e., %). differentiation, or, if ‘‘Calories from (8) Nutrient information for vitamins saturated fat’’ is declared, in a column and minerals shall be separated from with total ‘‘Calories’’ at the top, fol- information on other nutrients by a lowed by ‘‘Calories from fat’’ (in- bar and shall be arrayed horizontally dented), and ‘‘Calories from saturated (e.g., Vitamin A 4%, Vitamin C 2%, fat’’ (indented). Calcium 15%, Iron 4%) or may be listed (6) The column heading ‘‘% Daily in two columns, except that when more Value,’’ followed by an asterisk (e.g., than four vitamins and minerals are ‘‘% Daily Value*’’), shall be separated declared, they may be declared verti- from information on calories by a bar. cally with percentages listed under the The position of this column heading column headed ‘‘% Daily Value.’’ shall allow for a list of nutrient names (9) A footnote, preceded by an aster- and amounts as described in paragraph isk, shall be placed beneath the list of (d)(7) of this section to be to the left of, vitamins and minerals and shall be sep- and below, this column heading. The arated from that list by a hairline. column headings ‘‘Percent Daily (i) The footnote shall state: Percent Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may Daily Values are based on a 2,000 cal- be substituted for ‘‘% Daily Value.’’ orie diet. Your daily values may be (7) Except as provided for in para- higher or lower depending on your cal- graph (g) of this section, and except as permitted by § 317.400(d)(2), nutrient in- orie needs. formation for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be de- Calories: 2,000 2,500 clared in the nutrition label, except vitamins and minerals, shall be declared Total fat ...... Less than .... 65 g ...... 80 g as follows: Saturated fat Less than .... 20 g ...... 25 g Cholesterol ... Less than .... 300 mg ...... 300 mg (i) The name of each nutrient, as Sodium ...... Less than .... 2,400 mg ..... 2,400 mg specified in paragraph (c) of this sec- Total carbo- ...... 300 g ...... 375 g tion, shall be given in a column and hydrate. followed immediately by the quan- Dietary fiber ...... 25 g ...... 30 g titative amount by weight for that nutrient appended with a ‘‘g’’ for grams (ii) If the percent of Daily Value is or ‘‘mg’’ for milligrams. given for protein in the Percent of (ii) A listing of the percent of the Daily Value column as provided in DRV as established in paragraphs paragraph (d)(7)(ii) of this section, pro- (c)(7)(iii) and (c)(9) of this section shall tein shall be listed under dietary fiber, be given in a column aligned under the and a value of 50 g shall be inserted on heading ‘‘% Daily Value’’ established the same line in the column headed in paragraph (d)(6) of this section with ‘‘2,000’’ and value of 65 g in the column the percent expressed to the nearest headed ‘‘2,500.’’ whole percent for each nutrient de- (iii) If potassium is declared in the clared in the column described in para- column described in paragraph (d)(7)(i) graph (d)(7)(i) of this section for which

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of this section, potassium shall be list- (ii) If the space beneath the manda- ed under sodium and the DRV estab- tory declaration of iron is not adequate lished in paragraph (c)(9) of this sec- to accommodate any remaining vita- tion shall be inserted on the same line mins and minerals to be declared or the in the numeric columns. information required in paragraph (iv) The abbreviations established in (d)(9) of this section, the remaining in- paragraph (g)(2) of this section may be formation may be moved to the right used within the footnote. and set off by a line that distinguishes (10) Caloric conversion information it and sets it apart from the percent of on a per-gram basis for fat, carbo- Daily Value information given to the hydrate, and protein may be presented left. The caloric conversion informa- beneath the information required in tion provided for in paragraph (d)(10) of paragraph (d)(9), separated from that this section may be presented beneath information by a hairline. This infor- either side or along the full length of mation may be presented horizontally the nutrition label. (i.e., ‘‘Calories per gram: Fat 9, Carbo- (iii) If there is not sufficient continu- hydrate 4, Protein 4’’) or vertically in ous vertical space (i.e., approximately columns. 3 inches) to accommodate the required (11)(i) If the space beneath the infor- components of the nutrition label up to mation on vitamins and minerals is not and including the mandatory declara- adequate to accommodate the information of iron, the nutrition label may be tion required in paragraph (d)(9) of this presented in a tabular display in which section, the information required in the footnote required by paragraph paragraph (d)(9) may be moved to the (d)(9) of the section is given to the far right of the column required in para- right of the label, and additional vita- graph (d)(7)(ii) of this section and set mins and minerals beyond the four off by a line that distinguishes it and that are required (i.e., vitamin A, vita- sets it apart from the percent of Daily min C, calcium, and iron) are arrayed Value information. The caloric conver- horizontally following declarations of sion information provided for in para- the required vitamins and minerals. graph (d)(10) of this section may be pre- (12) The following sample label illus- sented beneath either side or along the trates the provisions of paragraph (d) full length of the nutrition label. of this section:

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(13)(i) Nutrition labeling on the outer used interchangeably for the same type label of packages of meat or meat food of food (e.g., meat salad containers) products that contain two or more may use an aggregate display. products in the same packages (e.g., (ii) Aggregate displays shall comply variety packs) or of packages that are with format requirements of paragraph

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(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 317.312(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language follow- tional column(s) either immediately ing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., ‘‘Pro- as packaged and according to the label tein/Proteinas 2 g’’). All required infor- serving size based on the Reference mation must be included in both lan- Amount in § 317.312(b) or as a footnote. guages. (A) If such additional quantitative (e) Nutrition information may be pre- information is given immediately adja- sented for two or more forms of the cent to the required quantitative infor- same product (e.g., both ‘‘raw’’ and mation, it shall be declared for all nu- ‘‘cooked’’) or for common combina- trients listed and placed immediately tions of foods as provided for in para- following and differentiated from the graph (b) of this section, or for dif- required quantitative information ferent units (e.g., per 100 grams) as pro- (e.g., separated by a comma). Such in- vided for in paragraph (b) of this sec- formation shall not be put in a sepa- tion, or for two or more groups for which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as ‘‘Amount Per Serving,’’ there shall be packaged for only those nutrients that two or more column headings accu- are present in different amounts than rately describing the forms of the same the amounts declared in the required product (e.g., ‘‘raw’’ and ‘‘roasted’’), quantitative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40 Amount in § 317.312(b) shall be to the calories, 65 mg sodium, 6 g total carbo- left of the numeric columns. hydrate (6 g sugars), and 4 g protein). (2) When the dual labeling is pre- (ii) Total fat and its quantitative sented for two or more forms of the amount by weight shall be followed by same product, for combinations of an asterisk (or other symbol) (e.g., foods, or for different units, total cal- ‘‘Total fat (2 g)*’’) referring to another ories and calories from fat (and cal- asterisk (or symbol) at the bottom of ories from saturated fat, when de- the nutrition label identifying the clared) shall be listed in a column and form(s) of the product for which quan- indented as specified in paragraph titative information is presented.

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(4) Information required in para- headings set forth in paragraph (e)(1) of graphs (d)(7)(ii) and (d)(8) of this sec- this section. tion shall be presented under the sub- (5) The following sample label illus- heading ‘‘% DAILY VALUE’’ and in trates the provisions of paragraph (e) columns directly under the column of this section:

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(f)(1) Nutrition information may be forth herein when any required nutri- presented in a simplified format as set ents, other than the core nutrients

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(i.e., calories, total fat, sodium, total are based on a 2,000 calorie diet’’ and, if carbohydrate, and protein), are present the term ‘‘Daily Value’’ is not spelled in insignificant amounts. An insignifi- out in the heading, a statement that cant amount shall be defined as that ‘‘DV’’ represents ‘‘Daily Value.’’ amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 317.302(a) by one or more of the follow- clude information on the following nu- ing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient Serving size—Serv size values and that is followed by the Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat graph (g) of this section and in Polyunsaturated fat—Polyunsat fat § 317.400(c) and (d), nutrient informa- Cholesterol—Cholest tion declared in the simplified format Total carbohydrate—Total carb shall be presented in the same manner Dietary fiber—Fiber as specified in paragraphs (d) or (e) of Soluble fiber—Sol fiber this section, except that the footnote Insoluble fiber—Insol fiber required in paragraph (d)(9) of this sec- Sugar alcohol—Sugar alc tion is not required. When the footnote Other carbohydrate—Other carb is omitted, an asterisk shall be placed (3) Omitting the footnote required in at the bottom of the label followed by paragraph (d)(9) of this section and the statement ‘‘Percent Daily Values placing another asterisk at the bottom

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of the label followed by the statement with 5 U.S.C. 552(a) and 1 CFR part 51. ‘‘Percent Daily Values are based on a Copies may be purchased from the 2,000 calorie diet’’ and, if the term AOAC International, 2200 Wilson Blvd., ‘‘Daily Value’’ is not spelled out in the suite 400, Arlington, VA 22201. It is also heading, a statement that ‘‘DV’’ rep- available for inspection at the Office of resents ‘‘Daily Value.’’ the Federal Register Information Cen- (4) Presenting the required nutrition ter, suite 700, 800 North Capitol Street, information on any other label panel. NW., Washington, DC. (h) Compliance with this section (3) Two classes of nutrients are de- shall be determined as follows: fined for purposes of compliance: (1) A production lot is a set of food (i) Class I. Added nutrients in for- production consumer units that are tified or fabricated foods; and from one production shift. Alter- (ii) Class II. Naturally occurring (in- natively, a collection of consumer digenous) nutrients. If any ingredient units of the same size, type, and style which contains a naturally occurring produced under conditions as nearly (indigenous) nutrient is added to a uniform as possible, designated by a food, the total amount of such nutrient common container code or marking, in the final food product is subject to constitutes a production lot. Class II requirements unless the same (2) The sample for nutrient analysis nutrient is also added, which would shall consist of a composite of a mini- make the total amount of such nutri- mum of six consumer units, each from ent subject to Class I requirements. a production lot. Alternatively, the (4) A product with a label declaration sample for nutrient analysis shall con- of a vitamin, mineral, protein, total sist of a composite of a minimum of six carbohydrate, dietary fiber, other car- consumer units, each randomly chosen bohydrate, polyunsaturated or to be representative of a production monounsaturated fat, or potassium lot. In each case, the units may be indi- shall be deemed to be misbranded vidually analyzed and the results of the under section 1(n) of the Federal Meat analyses averaged, or the units would Inspection Act (21 U.S.C. 601(n)(1)) un- be composited and the composite ana- less it meets the following require- lyzed. In both cases, the results, wheth- ments: er an average or a single result from a (i) Class I vitamin, mineral, protein, composite, will be considered by the dietary fiber, or potassium. The nutri- Agency to be the nutrient content of a ent content of the composite is at least composite. All analyses shall be per- equal to the value for that nutrient deformed by appropriate methods and clared on the label. procedures used by the Department for (ii) Class II vitamin, mineral, pro- each nutrient in accordance with the tein, total carbohydrate, dietary fiber, ‘‘Chemistry Laboratory Guidebook,’’ other carbohydrate, polyunsaturated or, if no USDA method is available and or monounsaturated fat, or potassium. appropriate for the nutrient, by appro- The nutrient content of the composite priate methods for the nutrient in ac- is at least equal to 80 percent of the cordance with the 1990 edition of the value for that nutrient declared on the ‘‘Official Methods of Analysis’’ of the label; Provided, That no regulatory ac- AOAC International, formerly Associa- tion will be based on a determination tion of Official Analytical Chemists, of a nutrient value which falls below 15th ed., which is incorporated by ref- this level by an amount less than the erence, unless a particular method of variability generally recognized for the analysis is specified in § 317.309(c), or, if analytical method used in that product no USDA, AOAC, or specified method is at the level involved, and inherent nu- available and appropriate, by other re- trient variation in a product. liable and appropriate analytical pro- (5) A product with a label declaration cedures as so determined by the Agen- of calories, sugars, total fat, saturated cy. The ‘‘Official Methods of Analysis’’ fat, cholesterol, or sodium shall be is incorporated as it exists on the date deemed to be misbranded under section of approval. This incorporation by ref- 1(n) of the Federal Meat Inspection Act erence was approved by the Director of (21 U.S.C. 601(n)(1)) if the nutrient con- the Federal Register in accordance tent of the composite is greater than 20

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percent in excess of the value for that (Reference Amount(s)), as set forth in nutrient declared on the label; Pro- paragraph (b) of this section, are: vided, That no regulatory action will be (1) The Reference Amounts are cal- based on a determination of a nutrient culated for persons 4 years of age or value which falls above this level by an older to reflect the amount of food cus- amount less than the variability gen- tomarily consumed per eating occasion erally recognized for the analytical by persons in this population group. method used in that product at the These Reference Amounts are based on level involved, and inherent nutrient data set forth in appropriate national variation in a product. food consumption surveys. (6) The amount of a vitamin, mineral, (2) The Reference Amounts are cal- protein, total carbohydrate, dietary culated for an infant or child under 4 fiber, other carbohydrate, polyunsat- years of age to reflect the amount of urated or monounsaturated fat, or po- food customarily consumed per eating tassium may vary over labeled occasion by infants up to 12 months of amounts within good manufacturing age or by children 1 through 3 years of practice. The amount of calories, sug- age, respectively. These Reference ars, total fat, saturated fat, choles- Amounts are based on data set forth in terol, or sodium may vary under la- appropriate national food consumption beled amounts within good manufac- surveys. Such Reference Amounts are turing practice. to be used only when the product is (7) Compliance will be based on the specially formulated or processed for metric measure specified in the label use by an infant or by a child under 4 statement of serving size. years of age. (8) The management of the establish- (3) An appropriate national food con- ment must maintain records to support sumption survey includes a large sam- the validity of nutrient declarations ple size representative of the demo- contained on product labels. Such graphic and socioeconomic characteris- records shall be made available to the tics of the relevant population group inspector or any duly authorized rep- and must be based on consumption resentative of the Agency upon re- data under actual conditions of use. quest. (4) To determine the amount of food (9) The compliance provisions set customarily consumed per eating occa- forth in paragraph (h) (1) through (8) of sion, the mean, median, and mode of this section shall not apply to single- the consumed amount per eating occa- ingredient, raw meat (including ground sion were considered. beef) products, including those that have been previously frozen, when nu- (5) When survey data were insuffi- trition labeling is based on the most cient, FSIS took various other sources current representative data base values of information on serving sizes of food contained in USDA’s National Nutrient into consideration. These other sources Data Bank or its published form, the of information included: Agriculture Handbook No. 8 series (i) Serving sizes used in dietary guid- available from the Government Print- ance recommendations or rec- ing Office. ommended by other authoritative systems or organizations; (Paperwork requirements were approved by (ii) Serving sizes recommended in the Office of Management and Budget under comments; control number 0583–0088) (iii) Serving sizes used by manufac- [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, turers and grocers; and 1993; 58 FR 47627, Sept. 10, 1993; 59 FR 45194, Sept. 1, 1994; 60 FR 176, Jan. 3, 1995] (iv) Serving sizes used by other countries. §§ 317.310–317.311 [Reserved] (6) Because they reflect the amount customarily consumed, the Reference § 317.312 Reference amounts customar- Amount and, in turn, the serving size ily consumed per eating occasion. declared on the product label are based (a) The general principles followed in on only the edible portion of food, and arriving at the reference amounts cus- not bone, seed, shell, or other inedible tomarily consumed per eating occasion components.

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(7) The Reference Amount is based on TABLE 1.ÐREFERENCE AMOUNTS CUSTOMARILY the major intended use of the product CONSUMED PER EATING OCCASIONÐINFANT (e.g., a mixed dish measurable with a AND TODDLER FOODS 1,2,3 cup as a main dish and not as a side Reference dish). Product category amount (8) The Reference Amounts for prod- Infant & Toddler Foods: ucts that are consumed as an ingredi- Dinner Dry Mix ...... 15 g ent of other products, but that may Dinner, ready-to-serve, strained type ...... 60 g also be consumed in the form in which Dinner, soups, ready-to-serve junior type ...... 110 g Dinner, stew or soup ready-to-serve toddlers 170 g they are purchased (e.g., ground beef), Plain meats and meat sticks, ready-to-serve .. 55 g are based on use in the form purchased. 1 These values represent the amount of food customarily (9) FSIS sought to ensure that foods consumed per eating occasion and were primarily derived from the 1977±1978 and the 1987±1988 Nationwide Food that have similar dietary usage, prod- Consumption Surveys conducted by the U.S. Department of uct characteristics, and customarily Agriculture. 2 Unless otherwise noted in the Reference Amount column, consumed amounts have a uniform Ref- the Reference Amounts are for the ready-to-serve or almost erence Amount. ready-to-serve form of the product (i.e., heat and serve). If not listed separately, the Reference Amount for the unprepared (b) The following Product Categories form (e.g., dehydrated cereal) is the amount required to make one Reference Amount of the prepared form. and Reference Amounts shall be used 3 Manufacturers are required to convert the Reference as the basis for determining serving Amount to the label serving size in a household measure most appropriate to their specific product using the proce- sizes for specific products: dures established by regulation.

TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young ...... 110 g n/a. Lard, margarine, shortening ...... 1 tbsp n/a. Salad and potato toppers; e.g., bacon bits ...... 7 g n/a. Bacon (bacon, beef breakfast strips, pork breakfast strips, pork rinds) ...... 15 g 54 g=bacon. 30 g = breakfast strips. Dried; e.g., jerky, dried beef, Parma ham sausage products with a moisture/protein ratio 30 g n/a. of less than 2:1; e.g., pepperoni. Snacks; e.g., meat snack food sticks ...... 30 g n/a. Luncheon meat, bologna, Canadian style bacon, pork pattie crumbles, beef pattie crum- 55 g n/a. bles, blood pudding, luncheon loaf, old fashioned loaf, berlinger, bangers, minced luncheon roll, thuringer, liver sausage, mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf, scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham, sandwich spread, teawurst, cervelet, Lebanon bologna, potted meat food product, taco fillings, meat pie fillings. Linked meat sausage products, Vienna sausage, frankfurters, pork sausage, imitation 55 g n/a. 75 frankfurters, bratwurst, kielbasa, Polish sausage, summer sausage, mettwurst, g=uncooked smoked country sausage, smoked sausage, smoked or pickled meat, pickled pigs feet. sausage. Entrees without sauce, cuts of meat including marinated, tenderized, injected cuts of 85 g 114 g. meat, beef patty, corn dog, croquettes, fritters, cured ham, dry cured ham, dry cured cappicola, corned beef, pastrami, country ham, pork shoulder picnic, meatballs, pureed adult foods. Canned meats, canned beef, canned pork. 4 ...... 55 g n/a. Entrees with sauce, barbecued meats in sauce ...... 140 g n/a. Mixed dishes NOT measurable with a cup; 5 e.g., burrito, egg roll, enchilada, pizza, 140 g (plus 55 g n/a. pizza roll, quiche, all types of sandwiches, cracker and meat lunch type packages, for products gyro, stromboli, burger on a bun, frank on a bun, calzone, taco, pockets stuffed with with sauce meat, foldovers, stuffed vegetables with meat, shish kabobs, empanada. toppings) Mixed dishes measurable with a cup; e.g., meat casserole, macaroni and cheese with 1 cup n/a. meat, pot pie, spaghetti with sauce, meat chili, chili with beans, meat hash, creamed chipped beef, beef ravioli in sauce, beef stroganoff, Brunswick stew, goulash, meat stew, ragout, meat lasagna, meat filled pasta. SaladsÐpasta or potato, potato salad with bacon, macaroni and meat salad ...... 140 g n/a. SaladsÐall other meat, salads, ham salad ...... 100 g n/a. SoupsÐall varieties ...... 245 g n/a. Major main entree type sauce; e.g., spaghetti sauce with meat, spaghetti sauce with 125 g n/a. meatballs. Minor main entree sauce; e.g., pizza sauce with meat, gravy ...... 1¤4 cup n/a. Seasoning mixes dry, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with meat..

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TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5ÐContinued

Reference Reference Product category amount amount Ready-to-serve Ready-to-cook

As reconstituted: Amount to make one Reference Amount of the final dish; e.g., Gravy ...... 1¤4 cup n/a. Major main entree type sauce ...... 125 g n/a. Soup ...... 245 g n/a. Entree measurable with a cup ...... 1 cup n/a. 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977±78 and the 1987±88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be sauce topping.

(c) For products that have no Ref- (d) If a product requires further prep- erence Amount listed in paragraph (b) aration, e.g., cooking or the addition of of this section for the unprepared or water or other ingredients, and if para- the prepared form of the product and graph (b) of this section provides a Ref- that consist of two or more foods erence Amount for the product in the packaged and presented to be prepared form, then the Reference consumed together (e.g., lunch meat Amount for the unprepared product with cheese and crackers), the Ref- shall be determined using the following erence Amount for the combined prod- rules: uct shall be determined using the fol- (1) Except as provided for in para- lowing rules: graph (d)(2) of this section, the Ref- (1) For bulk products, the Reference erence Amount for the unprepared Amount for the combined product shall product shall be the amount of the un- be the Reference Amount, as estab- prepared product required to make the lished in paragraph (b) of this section, Reference Amount for the prepared for the ingredient that is represented product as established in paragraph (b) as the main ingredient plus propor- of this section. tioned amounts of all minor ingredients. (2) For products where the entire (2) For products where the ingredient contents of the package is used to pre- represented as the main ingredient is pare one large discrete unit usually di- one or more discrete units, the Ref- vided for consumption, the Reference erence Amount for the combined prod- Amount for the unprepared product uct shall be either the number of small shall be the amount of the unprepared discrete units or the fraction of the product required to make the fraction large discrete unit that is represented of the large discrete unit closest to the as the main ingredient that is closest Reference Amount for the prepared to the Reference Amount for that in- product as established in paragraph (b) gredient as established in paragraph (b) of this section. of this section plus proportioned (e) The Reference Amount for an imi- amounts of all minor ingredients. tation or substitute product or altered (3) If the Reference Amounts are in product as defined in § 317.313(d), such compatible units, they shall be as a ‘‘low calorie’’ version, shall be the summed (e.g., ingredients in equal vol- same as for the product for which it is umes such as tablespoons). If the Ref- offered as a substitute. erence Amounts are in incompatible (f) The Reference Amounts set forth units, the weights of the appropriate in paragraphs (b) through (e) of this volumes should be used (e.g., grams of section shall be used in determining one ingredient plus gram weight of ta- whether a product meets the criteria blespoons of a second ingredient). for nutritional claims. If the serving

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size declared on the product label dif- sheets, suitably identified. If such data fers from the Reference Amount, and has already been submitted with an the product meets the criteria for the earlier labeling application from the claim only on the basis of the Ref- applicant, the present labeling applica- erence Amount, the claim shall be fol- tion must provide the data. lowed by a statement that sets forth (5) The labeling application must be the basis on which the claim is made. signed by the applicant or by his or her That statement shall include the Ref- attorney or agent, or (if a corporation) erence Amount as it appears in para- by an authorized official. graph (b) of this section followed, in (6) The labeling application shall in- parentheses, by the amount in common clude a statement signed by the person household measure if the Reference responsible for the labeling applica- Amount is expressed in measures other tion, that to the best of his or her than common household measures. knowledge, it is a representative and (g) The Administrator, on his or her balanced submission that includes un- own initiative or on behalf of any in- favorable information, as well as favor- terested person who has submitted a able information, known to him or her labeling application, may issue a pro- pertinent to the evaluation of the la- posal to establish or amend a Product beling application. Category or Reference Amount identi- (7) Labeling applications for a new fied in paragraph (b) of this section. Reference Amount and/or Product Cat- (1) Labeling applications and sup- egory shall be accompanied by the fol- porting documentation to be filed lowing data which shall be submitted under this section shall be submitted in the following form to the Director, in quadruplicate, except that the sup- Food Labeling Division, Regulatory porting documentation may be submit- Programs, Food Safety and Inspection ted on a computer disc copy. If any Service, Washington, DC 20250: part of the material submitted is in a ———————————————————————— foreign language, it shall be accom- (Date) panied by an accurate and complete The undersigned, llllll submits this English translation. The labeling appli- labeling application pursuant to 9 CFR cation shall state the applicant’s post 317.312 with respect to Reference Amount office address. and/or Product Category. (2) Pertinent information will be con- Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part sidered as part of an application on the of this labeling application, are the follow- basis of specific reference to such infor- ing: mation submitted to and retained in (i) A statement of the objective of the la- the files of the Food Safety and Inspec- beling application; tion Service. However, any reference to (ii) A description of the product; unpublished information furnished by a (iii) A complete sample product label in- person other than the applicant will cluding nutrition label, using the format established by regulation; not be considered unless use of such in- (iv) A description of the form in which the formation is authorized (with the un- product will be marketed; derstanding that such information may (v) The intended dietary uses of the prod- in whole or part be subject to release uct with the major use identified (e.g., ham to the public) in a written statement as a luncheon meat); signed by the person who submitted it. (vi) If the intended use is primarily as an Any reference to published information ingredient in other foods, list of foods or food categories in which the product will be used should be accompanied by reprints or as an ingredient with information on the photostatic copies of such references. prioritization of the use; (3) The availability for public disclo- (vii) The population group for which the sure of labeling applications, along product will be offered for use (e.g., infants, with supporting documentation, sub- children under 4 years of age); mitted to the Agency under this sec- (viii) The names of the most closely-relat- tion will be governed by the rules spec- ed products (or in the case of foods for special dietary use and imitation or substitute ified in subchapter D, title 9. foods, the names of the products for which (4) Data accompanying the labeling they are offered as substitutes); application, such as food consumption (ix) The suggested Reference Amount (the data, shall be submitted on separate amount of edible portion of food as

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consumed, excluding bone, skin or other in- control, how they affect interpretation of re- edible components) for the population group sults. for which the product is intended with full (D) The methodology used to collect or description of the methodology and proce- process data including study design, sam- dures that were used to determine the sug- pling procedures, materials used (e.g., ques- gested Reference Amount. In determining tionnaire, interviewer’s manual), procedures the Reference Amount, general principles used to collect or process data, methods or and factors in paragraph (a) of this section procedures used to control for unbiased esti- should be followed. mates, and procedures used to correct for (x) The suggested Reference Amount shall nonresponse, should be fully documented. be expressed in metric units. Reference (xiii) A statement concerning the feasibil- Amounts for foods shall be expressed in ity of convening associations, corporations, grams except when common household units consumers, and other interested parties to such as cups, tablespoons, and teaspoons are engage in negotiated rulemaking to develop more appropriate or are more likely to pro- a proposed rule. mote uniformity in serving sizes declared on Yours very truly, product labels. For example, common house- Applicant ——————————————— hold measures would be more appropriate if products within the same category differ By ——————————————————— substantially in density such as mixed dishes (Indicate authority) measurable with a cup. (8) Upon receipt of the labeling appli- (A) In expressing the Reference Amount in cation and supporting documentation, grams, the following general rules shall be followed: the applicant shall be notified, in writ- (1) For quantities greater than 10 grams, ing, of the date on which the labeling the quantity shall be expressed in nearest 5 application was received. Such notice grams increment. shall inform the applicant that the la- (2) For quantities less than 10 grams, exact beling application is undergoing Agen- gram weights shall be used. cy review and that the applicant shall (B) [Reserved] subsequently be notified of the Agen- (xi) A labeling application for a new sub- cy’s decision to consider for further re- category of food with its own Reference view or deny the labeling application. Amount shall include the following addi- (9) Upon review of the labeling appli- tional information: (A) Data that demonstrate that the new cation and supporting documentation, subcategory of food will be consumed in the Agency shall notify the applicant, amounts that differ enough from the Ref- in writing, that the labeling applica- erence Amount for the parent category to tion is either being considered for fur- warrant a separate Reference Amount. Data ther review or that it has been sum- must include sample size, and the mean, marily denied by the Administrator. standard deviation, median, and modal (10) If the labeling application is consumed amount per eating occasion for summarily denied by the Adminis- the product identified in the labeling application and for other products in the cat- trator, the written notification shall egory. All data must be derived from the state the reasons therefor, including same survey data. why the Agency has determined that (B) Documentation supporting the dif- the proposed Reference Amount and/or ference in dietary usage and product charac- Product Category is false or mislead- teristics that affect the consumption size ing. The notification letter shall in- that distinguishes the product identified in form the applicant that the applicant the labeling application from the rest of the may submit a written statement by products in the category. (xii) In conducting research to collect or way of answer to the notification, and process food consumption data in support of that the applicant shall have the right the labeling application, the following gen- to request a hearing with respect to eral guidelines should be followed. the merits or validity of the Adminis- (A) Sampled population selected should be trator’s decision to deny the use of the representative of the demographic and socio- proposed Reference Amount and/or economic characteristics of the target popu- Product Category. lation group for which the food is intended. (i) If the applicant fails to accept the (B) Sample size (i.e., number of eaters) determination of the Administrator should be large enough to give reliable estimates for customarily consumed amounts. and files an answer and requests a (C) The study protocol should identify po- hearing, and the Administrator, after tential biases and describe how potential bi- review of the answer, determines the ases are controlled for or, if not possible to initial determination to be correct, the

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Administrator shall file with the Hear- tion, and that the applicant shall have ing Clerk of the Department the notifi- the right to request a hearing with re- cation, answer, and the request for a spect to the merits or validity of the hearing, which shall constitute the Administrator’s decision to deny the complaint and answer in the proceed- use of the proposed Reference Amount ing, which shall thereafter be con- and/or Product Category. ducted in accordance with the Depart- (A) If the applicant fails to accept ment’s Uniform Rules of Practice. the determination of the Adminis- (ii) The hearing shall be conducted trator and files an answer and requests before an administrative law judge a hearing, and the Administrator, after with the opportunity for appeal to the review of an answer, determines the Department’s Judicial Officer, who initial determination to be correct, the shall make the final determination for Administrator shall file with the Hear- the Secretary. Any such determination ing Clerk of the Department the notifi- by the Secretary shall be conclusive cation, answer, and the request for a unless, within 30 days after receipt of hearing, which shall constitute the notice of such final determination, the complaint and answer in the proceed- applicant appeals to the United States ing, which shall thereafter be con- Court of Appeals for the circuit in ducted in accordance with the Depart- which the applicant has its principal ment’s Uniform Rules of Practice. place of business or to the United (B) The hearing shall be conducted States Court of Appeals for the District before an administrative law judge of Columbia Circuit. with the opportunity for appeal to the (11) If the labeling application is not Department’s Judicial Officer, who summarily denied by the Adminis- shall make the final determination for trator, the Administrator shall publish the Secretary. Any such determination in the FEDERAL REGISTER a proposed by the Secretary shall be conclusive rule to amend the regulations to au- unless, within 30 days after receipt of thorize the use of the Reference the notice of such final determination, Amount and/or Product Category. The the applicant appeals to the United proposal shall also summarize the la- States Court of Appeals for the circuit beling application, including where the in which the applicant has its principal supporting documentation can be replace of business or to the United viewed. The Administrator’s proposed States Court of Appeals for the District rule shall seek comment from consum- of Columbia Circuit. ers, the industry, consumer and indus- (ii) If the Reference Amount and/or try groups, and other interested per- Product Category is approved, the sons on the labeling application and Agency shall notify the applicant, in the use of the proposed Reference writing, and shall also publish in the Amount and/or Product Category. FEDERAL REGISTER a final rule amend- After public comment has been re- ing the regulations to authorize the ceived and reviewed by the Agency, the use of the Reference Amount and/or Administrator shall make a determina- Product Category. tion on whether the proposed Reference (Paperwork requirements were approved by Amount and/or Product Category shall the Office of Management and Budget under be approved for use on the labeling of control number 0583–0088) meat food products. [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (i) If the Reference Amount and/or 1993 as amended at 58 FR 47627, Sept. 10, 1993; Product Category is denied by the Ad- 59 FR 45196, Sept. 1, 1994; 60 FR 186, Jan. 3, ministrator, the Agency shall notify 1995] the applicant, in writing, of the basis for the denial, including the reason § 317.313 Nutrient content claims; gen- why the Reference Amount and/or eral principles. Product Category on the labeling was (a) This section applies to meat or determined by the Agency to be false meat food products that are intended or misleading. The notification letter for human consumption and that are shall also inform the applicant that the offered for sale. applicant may submit a written state- (b) A claim which, expressly or by ment by way of answer to the notifica- implication, characterizes the level of

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a nutrient (nutrient content claim) of (1) If there is a difference in perform- the type required in nutrition labeling ance characteristics that materially pursuant to § 317.309, may not be made limits the use of the product, the prod- on a label or in labeling of that product uct may still be considered a substitute unless the claim is made in accordance if the label includes a disclaimer adja- with the applicable provisions in this cent to the most prominent claim as subpart. defined in paragraph (j)(2)(iii) of this (1) An expressed nutrient content section, informing the consumer of claim is any direct statement about such difference (e.g., ‘‘not rec- the level (or range) of a nutrient in the ommended for frying’’). product, e.g., ‘‘low sodium’’ or ‘‘con- (2) This disclaimer shall be in easily tains 100 calories.’’ legible print or type and in a size no (2) An implied nutrient content claim less than that required by § 317.2(h) for is any claim that: the net quantity of contents state- (i) Describes the product or an ingre- ment, except where the size of the dient therein in a manner that sug- claim is less than two times the re- gests that a nutrient is absent or quired size of the net quantity of con- present in a certain amount (e.g., tents statement, in which case the dis- ‘‘high in oat bran’’); or claimer statement shall be no less than (ii) Suggests that the product, be- one-half the size of the claim but no cause of its nutrient content, may be smaller than 1⁄16-inch minimum height, useful in maintaining healthy dietary except as permitted by § 317.400(d)(2). practices and is made in association (e)(1) Because the use of a ‘‘free’’ or with an explicit claim or statement ‘‘low’’ claim before the name of a prod- about a nutrient (e.g., ‘‘healthy, con- uct implies that the product differs tains 3 grams (g) of fat’’). from other products of the same type (3) Except for claims regarding vita- by virtue of its having a lower amount mins and minerals described in para- of the nutrient, only products that graph (q)(3) of this section, no nutrient have been specially processed, altered, content claims may be made on prod- formulated, or reformulated so as to ucts intended specifically for use by in- lower the amount of the nutrient in fants and children less than 2 years of the product, remove the nutrient from age unless the claim is specifically pro- the product, or not include the nutri- vided for in subpart B of this part. ent in the product, may bear such a (4) Reasonable variations in the spell- claim (e.g., ‘‘low sodium beef noodle ing of the terms defined in applicable soup’’). provisions in this subpart and their (2) Any claim for the absence of a nu- synonyms are permitted provided these trient in a product, or that a product is variations are not misleading (e.g., low in a nutrient when the product has ‘‘hi’’ or ‘‘lo’’). not been specially processed, altered, (c) Information that is required or formulated, or reformulated to qualify permitted by § 317.309 to be declared in for that claim shall indicate that the nutrition labeling, and that appears as product inherently meets the criteria part of the nutrition label, is not a nu- and shall clearly refer to all products trient content claim and is not subject of that type and not merely to the par- to the requirements of this section. If ticular brand to which the labeling at- such information is declared elsewhere taches (e.g., ‘‘lard, a sodium free on the label or in labeling, it is a nutri- food’’). ent content claim and is subject to the (f) A nutrient content claim shall be requirements for nutrient content in type size and style no larger than claims. two times that of the statement of (d) A ‘‘substitute’’ product is one identity and shall not be unduly promi- that may be used interchangeably with nent in type style compared to the another product that it resembles, i.e., statement of identity. that it is organoleptically, physically, (g) Labeling information required in and functionally (including shelf life) §§ 317.313, 317.354, 317.356, 317.360, 317.361, similar to, and that it is not nutrition- 317.362, and 317.380, whose type size is ally inferior to unless it is labeled as not otherwise specified, is required to an ‘‘imitation.’’ be in letters and/or numbers no less

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than 1⁄16 inch in height, except as per- pared to an amount of nutrient in an mitted by § 317.400(d)(2). appropriate reference product as speci- (h) [Reserved] fied in this paragraph (j). (i) Except as provided in § 317.309 or in (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and paragraph (q)(3) of this section, the ‘‘more’’ claims, the reference product label or labeling of a product may con- may be a dissimilar product within a tain a statement about the amount or product category that can generally be percentage of a nutrient if: substituted for one another in the diet (1) The use of the statement on the or a similar product. product implicitly characterizes the (B) For ‘‘light,’’ ‘‘reduced,’’ and level of the nutrient in the product and ‘‘added’’ claims, the reference product is consistent with a definition for a shall be a similar product, and claim, as provided in subpart B of this (ii)(A) For ‘‘light’’ claims, the ref- part, for the nutrient that the label ad- erence product shall be representative dresses. Such a claim might be, ‘‘less of the type of product that includes the than 10 g of fat per serving;’’ product that bears the claim. The nu- (2) The use of the statement on the trient value for the reference product product implicitly characterizes the shall be representative of a broad base level of the nutrient in the product and of products of that type; e.g., a value in is not consistent with such a defini- a representative, valid data base; an tion, but the label carries a disclaimer average value determined from the top adjacent to the statement that the three national (or regional) brands, a product is not ‘‘low’’ in or a ‘‘good market basket norm; or, where its nu- source’’ of the nutrient, such as ‘‘only trient value is representative of the 200 milligrams (mg) sodium per serv- product type, a market leader. Firms ing, not a low sodium product.’’ The using such a reference nutrient value disclaimer must be in easily legible as a basis for a claim, are required to print or type and in a size no less than provide specific information upon required by § 317.2(h) for the net quan- which the nutrient value was derived, tity of contents, except where the size on request, to consumers and appro- of the claim is less than two times the priate regulatory officials. required size of the net quantity of (B) For relative claims other than contents statement, in which case the ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ disclaimer statement shall be no less claims, the reference product may be than one-half the size of the claim but the same as that provided for ‘‘light’’ no smaller than 1⁄16-inch minimum in paragraph (j)(1)(ii)(A) of this section height, except as permitted by or it may be the manufacturer’s regu- § 317.400(d)(2); lar product, or that of another manu- (3) The statement does not in any facturer, that has been offered for sale way implicitly characterize the level of to the public on a regular basis for a the nutrient in the product and it is substantial period of time in the same not false or misleading in any respect geographic area by the same business (e.g., ‘‘100 calories’’ or ‘‘5 grams of entity or by one entitled to use its fat’’), in which case no disclaimer is re- trade name, provided the name of the quired. competitor is not used on the labeling (4) ‘‘Percent fat free’’ claims are not of the product. The nutrient values authorized by this paragraph. Such used to determine the claim when com- claims shall comply with § 317.362(b)(6). paring a single manufacturer’s product (j) A product may bear a statement to the labeled product shall be either that compares the level of a nutrient in the values declared in nutrition label- the product with the level of a nutrient ing or the actual nutrient values, pro- in a reference product. These state- vided that the resulting labeling is in- ments shall be known as ‘‘relative ternally consistent (i.e., that the val- claims’’ and include ‘‘light,’’ ‘‘re- ues stated in the nutrition informa- duced,’’ ‘‘less’’ (or ‘‘fewer’’), and tion, the nutrient values in the accom- ‘‘more’’ claims. panying information, and the declara- (1) To bear a relative claim about the tion of the percentage of nutrient by level of a nutrient, the amount of that which the product has been modified nutrient in the product must be com- are consistent and will not cause

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consumer confusion when compared), (k) The term ‘‘modified’’ may be used and that the actual modification is at in the statement of identity of a prod- least equal to the percentage specified uct that bears a relative claim that in the definition of the claim. complies with the requirements of this (2) For products bearing relative part, followed immediately by the claims: name of the nutrient whose content (i) The label or labeling must state has been altered (e.g., ‘‘modified fat the identity of the reference product ‘product’ ’’). This statement of identity and the percent (or fraction) of the must be immediately followed by the amount of the nutrient in the reference comparative statement such as ‘‘con- product by which the nutrient has been tains 35 percent less fat than ‘reference modified, (e.g., ‘‘50 percent less fat product’.’’ The label or labeling must than ‘reference product’ ’’ or ‘‘1⁄3 fewer also bear the information required by calories than ‘reference product’ ’’); and paragraph (j)(2) of this section in the (ii) This information shall be imme- manner prescribed. diately adjacent to the most prominent (l) For purposes of making a claim, a claim in easily legible boldface print or ‘‘meal-type product’’ shall be defined type, in distinct contrast to other as a product that: printed or graphic matter, that is no (1) Makes a significant contribution less than that required by § 317.2(h) for to the diet by weighing at least 6 net quantity of contents, except where ounces, but no more than 12 ounces per the size of the claim is less than two serving (container), and times the required size of the net quan- (2) Contains ingredients from two or tity of contents statement, in which more of the following four food groups: case the referral statement shall be no (i) Bread, cereal, rice and pasta less than one-half the size of the claim, group, but no smaller than 1⁄16-inch minimum (ii) Fruits and vegetables group, height, except as permitted by (iii) Milk, yogurt, and cheese group, § 317.400(d)(2). and (iii) The determination of which use (iv) Meat, poultry, fish, dry beans, of the claim is in the most prominent eggs, and nuts group, and location on the label or labeling will be (3) Is represented as, or is in a form made based on the following factors, commonly understood to be a break- considered in order: fast, lunch, dinner, meal, main dish, (A) A claim on the principal display entree, or pizza. Such representations panel adjacent to the statement of may be made either by statements, identity; photographs, or vignettes. (B) A claim elsewhere on the prin- (m) [Reserved] cipal display panel; (n) Nutrition labeling in accordance (C) A claim on the information panel; with § 317.309, shall be provided for any or food for which a nutrient content claim (D) A claim elsewhere on the label or is made. labeling. (o) Compliance with requirements for (iv) The label or labeling must also nutrient content claims shall be in ac- bear: cordance with § 317.309(h). (A) Clear and concise quantitative in- (p)(1) Unless otherwise specified, the formation comparing the amount of reference amount customarily the subject nutrient in the product per consumed set forth in § 317.312(b) labeled serving size with that in the through (e) shall be used in determin- reference product; and ing whether a product meets the cri- (B) This statement shall appear adja- teria for a nutrient content claim. If cent to the most prominent claim or to the serving size declared on the prod- the nutrition information. uct label differs from the reference (3) A relative claim for decreased lev- amount customarily consumed, and the els of a nutrient may not be made on amount of the nutrient contained in the label or in labeling of a product if the labeled serving does not meet the the nutrient content of the reference maximum or minimum amount cri- product meets the requirement for a terion in the definition for the ‘‘low’’ claim for that nutrient. descriptor for that nutrient, the claim

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shall be followed by the criteria for the a claim may be submitted pursuant to claim as required by § 317.312(f) (e.g., § 317.369. ‘‘very low sodium, 35 mg or less per 55 [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, grams’’). 1993, as amended at 58 FR 47627, Sept. 10, (2) The criteria for the claim shall be 1993; 59 FR 40213, Aug. 8, 1994; 59 FR 45196, immediately adjacent to the most Sept. 1, 1994; 60 FR 187, Jan. 3, 1995] prominent claim in easily legible print or type and in a size that is no less §§ 317.314–317.342 [Reserved] than that required by § 317.2(h) for net § 317.343 Significant participation for quantity of contents, except where the voluntary nutrition labeling. size of the claim is less than two times (a) In evaluating significant partici- the required size of the net quantity of pation for voluntary nutrition labeling, contents statement, in which case the FSIS will consider only the major cuts criteria statement shall be no less than of single-ingredient, raw meat prod- one-half the size of the claim but no ucts, as identified in § 317.344, including smaller than 1⁄16-inch minimum height, those that have been previously frozen. except as permitted by § 317.400(d)(2). (b) FSIS will judge a food retailer to (q) The following exemptions apply: be participating at a significant level if (1) Nutrient content claims that have the retailer provides nutrition labeling not been defined by regulation and that information for at least 90 percent of appear as part of a brand name that the major cuts of single-ingredient, was in use prior to November 27, 1991, raw meat products, listed in § 317.344, may continue to be used as part of that that it sells, and if the nutrition label brand name, provided they are not is consistent in content and format false or misleading under section 1(n) with the mandatory program, or nutri- of the Act (21 U.S.C. 601(n)(1)). tion information is displayed at point- of-purchase in an approriate manner. (2) [Reserved] (c) To determine whether there is sig- (3) A statement that describes the nificant participation by retailers percentage of a vitamin or mineral in under the voluntary nutrition labeling the food, including foods intended spe- guidelines, FSIS will select a rep- cifically for use by infants and children resentative sample of companies allo- less than 2 years of age, in relation to cated by type and size. a Reference Daily Intake (RDI) as de- (d) FSIS will find that significant fined in § 317.309 may be made on the participation by food retailers exists if label or in the labeling of a food with- at least 60 percent of all companies out a regulation authorizing such a that are evaluated are participating in claim for a specific vitamin or mineral. accordance with the guidelines. (4) The requirements of this section (e) FSIS will evaluate significant do not apply to infant formulas and participation of the voluntary program medical foods, as described in 21 CFR every 2 years beginning in May 1995. 101.13(q)(4). (1) If significant participation is (5) [Reserved] found, the voluntary nutrition labeling (6) Nutrient content claims that were guidelines shall remain in effect. (2) If significant participation is not part of the name of a product that was found, FSIS shall initiate rulemaking subject to a standard of identity as of to require nutrition labeling on those November 27, 1991, are not subject to products under the voluntary program. the requirements of paragraph (b) of this section whether or not they meet § 317.344 Identification of major cuts the definition of the descriptive term. of meat products. (7) Implied nutrient content claims The major cuts of single-ingredient, may be used as part of a brand name, raw meat products are: Beef chuck provided that the use of the claim has blade roast, beef loin top loin steak, been authorized by FSIS. Labeling ap- beef rib roast large end, beef round eye plications requesting approval of such round steak, beef round top round

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steak, beef round tip roast, beef chuck if only nutrition information—and not arm pot roast, beef loin sirloin steak, a nutrition claim—is supplied on point- beef round bottom round steak, beef of-purchase materials: brisket (whole, flat half, or point half), (i) The requirements of the manda- beef rib steak small end, beef loin ten- tory nutrition labeling program apply, derloin steak, ground beef regular but the nutrition information may be without added seasonings, ground beef supplied on an ‘‘as packaged’’ or ‘‘as about 17% fat, pork loin chop, pork consumed,’’ basis; loin country style ribs, pork loin top (ii) The listing of percent of Daily loin chop boneless, pork loin rib chop, Value for the nutrients (except vita- pork spareribs, pork loin tenderloin, mins and minerals specified in pork loin sirloin roast, pork shoulder § 317.309(c)(8)) and footnote required by blade steak, pork loin top roast § 317.309(d)(9) may be omitted; and boneless, ground pork, lamb shank, (iii) The point-of-purchase materials lamb shoulder arm chop, lamb shoulder are not subject to any of the format re- blade chop, lamb rib roast, lamb loin quirements. chop, lamb leg (whole, sirloin half, or shank half), veal shoulder arm steak, (b) [Reserved] veal shoulder blade steak, veal rib (c) The declaration of nutrition infor- roast, veal loin chop, and veal cutlets. mation may be presented in a simplified format as specified in § 317.309(f) [58 FR 664, Jan. 6, 1993, as amended at 59 FR for the mandatory nutrition labeling 45196, Sept. 1, 1994] program. § 317.345 Guidelines for voluntary nu- (d) The nutrition label data should be trition labeling of single-ingredient, based on either the raw or cooked edi- raw products. ble portions of meat cuts with external (a) Nutrition information on the cuts cover fat at trim levels reflecting cur- of single-ingredient, raw meat prod- rent marketing practices. If data are ucts, including those that have been based on cooked portions, the methods previously frozen, shall be provided in used to cook the products must be the following manner: specified and should be those which do (1) If a retailer or manufacturer not add nutrients from other ingredi- chooses to provide nutrition informa- ents such as flour, breading, and salt. tion on the label of these products, Additional nutritional data may be these products shall be subject to all presented on an optional basis for the requirements of the mandatory nutri- raw or cooked edible portions of the tion labeling program, except that nu- separable lean of meat cuts. trition labeling may be declared on the (e) Nutrient data that are the most basis of either ‘‘as consumed’’ or ‘‘as current representative data base values packaged.’’ In addition, the declaration contained in USDA’s National Nutrient of the number of servings per container Data Bank or its published form, the need not be included in nutrition label- Agriculture Handbook No. 8 series, ing of single-ingredient, raw meat may be used for nutrition labeling of products (including ground beef), in- single-ingredient, raw meat products cluding those that have been pre- (including ground beef), including viously frozen. those that have been previously frozen. (2) A retailer may choose to provide These data may be composite data that nutrition information at the point-of- reflect different quality grades of beef purchase, such as by posting a sign, or or other variables affecting nutrient by making the information readily content. Alternatively, data that re- available in brochures, notebooks, or flect specific grades or other variables leaflet form in close proximity to the may be used, except that if data are food. The nutrition labeling informa- used on labels attached to a product tion may also be supplemented by a which is labeled as to grade of meat or video, live demonstration, or other other variables, the data must rep- media. If a nutrition claim is made on resent the product in the package when point-of-purchase materials all of the such data are contained in the rep- requirements of the mandatory nutri- resentative data base. When data are tion labeling program apply. However, used on labels attached to a product,

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the data must represent the edible product as defined in § 317.313(l), pro- meat tissues present in the package. vided that: (f) If the nutrition information is in (i) The product contains a food that accordance with paragraph (e) of this meets the definition of ‘‘high’’ in para- section, a nutrition label or labeling graph (b)(1) of this section; and will not be subject to the Agency com- (ii) The label or labeling clearly iden- pliance review under § 317.309(h), unless tifies the food that is the subject of the a nutrition claim is made on the basis claim (e.g., ‘‘the serving of broccoli in of the representative data base values. this meal is high in vitamin C’’). (g) Retailers may use data bases that (c) ‘‘Good Source’’ claims. (1) The they believe reflect the nutrient con- terms ‘‘good source,’’ ‘‘contains,’’ or tent of single-ingredient, raw meat ‘‘provides’’ may be used on the label or products (including ground beef), in- in labeling of products, except meal- cluding those that have been pre- type products as described in viously frozen; however, such labeling § 317.313(l), provided that the product shall be subject to the compliance pro- contains 10 to 19 percent of the RDI or cedures of paragraph (e) of this section the DRV per reference amount cus- and the requirements specified in this tomarily consumed. subpart for the mandatory nutrition (2) The terms defined in paragraph labeling program. (c)(1) of this section may be used on the label or in labeling of a meal-type [58 FR 664, Jan. 6, 1993, as amended at 58 FR product as defined in § 317.313(l), pro- 47627, Sept. 10, 1993; 60 FR 189, Jan. 3, 1995] vided that: (i) The product contains a food that § 317.346–317.353 [Reserved] meets the definition of ‘‘good source’’ § 317.354 Nutrient content claims for in paragraph (c)(1) of this section; and ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ (ii) The label or labeling clearly identifies the food that is the subject of the (a) General requirements. Except as claim (e.g., ‘‘the serving of sweet pota- provided in paragraph (e) of this sec- toes in this meal is a good source of tion, a claim about the level of a nutri- fiber’’). ent in a product in relation to the Ref- (d) Fiber claims. (1) If a nutrient con- erence Daily Intake (RDI) or Daily Ref- tent claim is made with respect to the erence Value (DRV) established for level of dietary fiber, i.e., that the that nutrient (excluding total carbo- product is high in fiber, a good source hydrate) in § 317.309(c), may only be of fiber, or that the product contains made on the label or in labeling of the ‘‘more’’ fiber, and the product is not product if: ‘‘low’’ in total fat as defined in (1) The claim uses one of the terms § 317.362(b)(2) or, in the case of a meal- defined in this section in accordance type product, is not ‘‘low’’ in total fat with the definition for that term; as defined in § 317.362(b)(3), then the la- (2) The claim is made in accordance beling shall disclose the level of total with the general requirements for nu- fat per labeled serving size (e.g., ‘‘con- trient content claims in § 317.313; and tains 12 grams (g) of fat per serving’’); (3) The product for which the claim is and made is labeled in accordance with (2) The disclosure shall appear in im- § 317.309. mediate proximity to such claim and (b) ‘‘High’’ claims. (1) The terms be in a type size no less than one-half ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source the size of the claim. of’’ may be used on the label or in la- (e) ‘‘More’’ claims. (1) A relative claim beling of products, except meal-type using the terms ‘‘more’’ and ‘‘added’’ products as defined in § 317.313(l), pro- may be used on the label or in labeling vided that the product contains 20 per- to describe the level of protein, vita- cent or more of the RDI or the DRV per mins, minerals, dietary fiber, or potas- reference amount customarily sium in a product, except meal-type consumed. products as defined in § 317.313(l), pro- (2) The terms defined in paragraph vided that: (b)(1) of this section may be used on (i) The product contains at least 10 the label or in labeling of a meal-type percent more of the RDI or the DRV

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for protein, vitamins, minerals, dietary ‘reference product’ is 2 g per 3 oz; ‘this fiber, or potassium (expressed as a per- product’ contains 5 g per 3 oz’’). cent of the Daily Value) per reference amount customarily consumed than an [60 FR 189, Jan. 3, 1995] appropriate reference product as de- § 317.355 [Reserved] scribed in § 317.313(j)(1); and (ii) As required in § 317.313(j)(2) for § 317.356 Nutrient content claims for relative claims: ‘‘light’’ or ‘‘lite.’’ (A) The identity of the reference (a) General requirements. A claim product and the percent (or fraction) using the terms ‘‘light’’ or ‘‘lite’’ to de- that the nutrient is greater relative to scribe a product may only be made on the RDI or DRV are declared in imme- the label or in labeling of the product diate proximity to the most prominent if: such claim (e.g., ‘‘contains 10 percent (1) The claim uses one of the terms more of the Daily Value for fiber than defined in this section in accordance ‘reference product’ ’’); and with the definition for that term; (B) Quantitative information com- (2) The claim is made in accordance paring the level of the nutrient in the with the general requirements for nu- product per labeled serving size with trient content claims in § 317.313; and that of the reference product that it replaces is declared adjacent to the most (3) The product for which the claim is prominent claim or to the nutrition in- made is labeled in accordance with formation (e.g., ‘‘fiber content of ‘ref- § 317.309. erence product’ is 1 g per serving; ‘this (b) ‘‘Light’’ claims. The terms ‘‘light’’ product’ contains 4 g per serving’’). or ‘‘lite’’ may be used on the label or in (2) A relative claim using the terms labeling of products, except meal-type ‘‘more’’ and ‘‘added’’ may be used on products as defined in § 317.313(l), with- the label or in labeling to describe the out further qualification, provided level of protein, vitamins, minerals, di- that: etary fiber, or potassium in meal-type (1) If the product derives 50 percent products as defined in § 317.313(l), pro- or more of its calories from fat, its fat vided that: content is reduced by 50 percent or (i) The product contains at least 10 more per reference amount customar- percent more of the RDI or the DRV ily consumed compared to an appro- for protein, vitamins, minerals, dietary priate reference product as described in fiber, or potassium (expressed as a per- § 317.313(j)(1); or cent of the Daily Value) per 100 g of (2) If the product derives less than 50 product than an appropriate reference percent of its calories from fat: product as described in § 317.313(j)(1); (i) The number of calories is reduced and by at least one-third (331⁄3 percent) per (ii) As required in § 317.313(j)(2) for reference amount customarily relative claims: consumed compared to an appropriate (A) The identity of the reference reference product as described in product and the percent (or fraction) § 317.313(j)(1); or that the nutrient is greater relative to (ii) Its fat content is reduced by 50 the RDI or DRV are declared in imme- percent or more per reference amount diate proximity to the most prominent customarily consumed compared to the such claim (e.g., ‘‘contains 10 percent appropriate reference product as de- more of the Daily Value for fiber per 3 scribed in § 317.313(j)(1); and ounces (oz) than does ‘reference prod- (3) As required in § 317.313(j)(2) for rel- uct’ ’’), and ative claims: (B) Quantitative information com- (i) The identity of the reference prod- paring the level of the nutrient in the uct and the percent (or fraction) that meal-type product per specified weight the calories and the fat were reduced with that of the reference product that are declared in immediate proximity to it replaces is declared adjacent to the the most prominent such claim (e.g., most prominent claim or to the nutri- ‘‘1⁄3 fewer calories and 50 percent less tion information (e.g., ‘‘fiber content of fat than the market leader’’); and

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(ii) Quantitative information com- (ii) As required in § 317.313(j)(2) for paring the level of calories and fat con- relative claims: tent in the product per labeled serving (A) The identity of the reference size with that of the reference product product and the percent (or fraction) that it replaces is declared adjacent to that the sodium was reduced are de- the most prominent claim or to the nu- clared in immediate proximity to the trition information (e.g., ‘‘lite ‘this most prominent such claim (e.g., ‘‘50 product’—200 calories, 4 grams (g) fat; percent less sodium than the market regular ‘reference product’—300 cal- leader’’); and ories, 8 g fat per serving’’); and (B) Quantitative information com- (iii) If the labeled product contains paring the level of sodium per labeled less than 40 calories or less than 3 g fat serving size with that of the reference per reference amount customarily product it replaces is declared adjacent consumed, the percentage reduction for to the most prominent claim or to the that nutrient need not be declared. nutrition information (e.g., or ‘‘lite (4) A ‘‘light’’ claim may not be made ‘this product’—170 mg sodium per serv- on a product for which the reference ing; regular ‘reference product’—350 mg product meets the definition of ‘‘low per serving’’). fat’’ and ‘‘low calorie.’’ (3) Except for meal-type products as (c)(1)(i) A product for which the ref- defined in § 317.313(l), a ‘‘light in sodium’’ claim may not be made on a erence product contains 40 calories or product for which the reference prod- less and 3 g fat or less per reference uct meets the definition of ‘‘low in so- amount customarily consumed may dium.’’ use the terms ‘‘light’’ or ‘‘lite’’ without (d)(1) The terms ‘‘light’’ or ‘‘lite’’ further qualification if it is reduced by may be used on the label or in labeling 50 percent or more in sodium content of a meal-type product as defined in compared to the reference product; and § 317.313(l), provided that: (ii) As required in § 317.313(j)(2) for (i) The product meets the definition relative claims: of: (A) The identity of the reference (A) ‘‘Low in calories’’ as defined in product and the percent (or fraction) § 317.360(b)(3); or that the sodium was reduced are de- (B) ‘‘Low in fat’’ as defined in clared in immediate proximity to the § 317.362(b)(3); and most prominent such claim (e.g., ‘‘50 (ii)(A) A statement appears on the percent less sodium than the market principal display panel that explains leader’’); and whether ‘‘light’’ is used to mean ‘‘low (B) Quantitative information com- fat,’’ ‘‘low calories,’’ or both (e.g., paring the level of sodium per labeled ‘‘Light Delight, a low fat meal’’); and serving size with that of the reference (B) The accompanying statement is product it replaces is declared adjacent no less than one-half the type size of to the most prominent claim or to the the ‘‘light’’ or ‘‘lite’’ claim. nutrition information (e.g., ‘‘lite ‘this (2)(i) The terms ‘‘light in sodium’’ or product’—500 milligrams (mg) sodium ‘‘lite in sodium’’ may be used on the per serving; regular ‘reference prod- label or in labeling of a meal-type uct’—1,000 mg sodium per serving’’). product as defined in § 317.313(l), pro- (2)(i) A product for which the ref- vided that the product meets the defi- erence product contains more than 40 nition of ‘‘low in sodium’’ as defined in calories or more than 3 g fat per ref- § 317.361(b)(5)(i); and erence amount customarily consumed (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- may use the terms ‘‘light in sodium’’ dium’’ are presented in uniform type or ‘‘lite in sodium’’ if it is reduced by size, style, color, and prominence. 50 percent or more in sodium content (3) The term ‘‘light’’ or ‘‘lite’’ may be compared to the reference product, pro- used in the brand name of a product to vided that ‘‘light’’ or ‘‘lite’’ is pre- describe the sodium content, provided sented in immediate proximity with that: ‘‘in sodium’’ and the entire term is pre- (i) The product is reduced by 50 per- sented in uniform type size, style, cent or more in sodium content com- color, and prominence; and pared to the reference product;

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(ii) A statement specifically stating adjacent to the nutrition information that the product is ‘‘light in sodium’’ and the information required to accom- or ‘‘lite in sodium’’ appears: pany a relative claim shall appear on (A) Contiguous to the brand name; the label or labeling as specified in and § 317.313(j)(2). (B) In uniform type size, style, color, [60 FR 189, Jan. 3, 1995] and prominence as the product name; and §§ 317.357–317.359 [Reserved] (iii) As required in § 317.313(j)(2) for relative claims: § 317.360 Nutrient content claims for (A) The identity of the reference calorie content. product and the percent (or fraction) (a) General requirements. A claim that the sodium was reduced are de- about the calorie or sugar content of a clared in immediate proximity to the product may only be made on the label most prominent such claim; and or in labeling of the product if: (B) Quantitative information com- (1) The claim uses one of the terms paring the level of sodium per labeled defined in this section in accordance serving size with that of the reference with the definition for that term; product it replaces is declared adjacent (2) The claim is made in accordance to the most prominent claim or to the with the general requirements for nu- nutrition information. trient content claims in § 317.313; and (e) Except as provided in paragraphs (3) The product for which the claim is (b) through (d) of this section, the made is labeled in accordance with terms ‘‘light’’ or ‘‘lite’’ may not be § 317.309. used to refer to a product that is not (b) Calorie content claims. (1) The reduced in fat by 50 percent, or, if ap- terms ‘‘calorie free,’’ ‘‘free of calories,’’ plicable, in calories by 1⁄3 or, when ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- properly qualified, in sodium by 50 per- out calories,’’ ‘‘trivial source of cal- cent unless: ories,’’ ‘‘negligible source of calories,’’ (1) It describes some physical or or ‘‘dietarily insignificant source of organoleptic attribute of the product calories’’ may be used on the label or such as texture or color and the infor- in labeling of products, provided that: mation (e.g., ‘‘light in color’’ or ‘‘light (i) The product contains less than 5 in texture’’) so stated, clearly conveys calories per reference amount cus- the nature of the product; and tomarily consumed and per labeled (2) The attribute (e.g., ‘‘color’’ or serving size; and ‘‘texture’’) is in the same style, color, (ii) If the product meets this condi- and at least one-half the type size as tion without the benefit of special the word ‘‘light’’ and in immediate processing, alteration, formulation, or proximity thereto. reformulation to lower the caloric con- (f) If a manufacturer can dem- tent, it is labeled to clearly refer to all onstrate that the word ‘‘light’’ has products of its type and not merely to been associated, through common use, the particular brand to which the label with a particular product to reflect a attaches. physical or organoleptic attribute to (2) The terms ‘‘low calorie,’’ ‘‘few cal- the point where it has become part of ories,’’ ‘‘contains a small amount of the statement of identity, such use of calories,’’ ‘‘low source of calories,’’ or the term ‘‘light’’ shall not be consid- ‘‘low in calories’’ may be used on the ered a nutrient content claim subject label or in labeling of products, except to the requirements in this part. meal-type products as defined in (g) The term ‘‘lightly salted’’ may be § 317.313(l), provided that: used on a product to which has been (i)(A) The product has a reference added 50 percent less sodium than is amount customarily consumed greater normally added to the reference prod- than 30 grams (g) or greater than 2 ta- uct as described in § 317.313(j)(1)(i)(B) blespoons (tbsp) and does not provide and (j)(1)(ii)(B), provided that if the more than 40 calories per reference product is not ‘‘low in sodium’’ as de- amount customarily consumed; or fined in § 317.361(b)(4), the statement (B) The product has a reference ‘‘not a low sodium food,’’ shall appear amount customarily consumed of 30 g

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or less or 2 tbsp or less and does not uct per labeled serving size with that of provide more than 40 calories per ref- the reference product that it replaces erence amount customarily consumed is declared adjacent to the most promi- and per 50 g (for dehydrated products nent claim or to the nutrition informa- that must be reconstituted before typi- tion (e.g., ‘‘calorie content has been re- cal consumption with water or a dilu- duced from 150 to 100 calories per serv- ent containing an insignificant ing’’). amount, as defined in § 317.309(f)(1), of (iii) Claims described in paragraph all nutrients per reference amount cus- (b)(4) of this section may not be made tomarily consumed, the per-50-g cri- on the label or in labeling of products terion refers to the ‘‘as prepared’’ if the reference product meets the defi- form). nition for ‘‘low calorie.’’ (ii) If the product meets these condi- (5) The terms defined in paragraph tions without the benefit of special (b)(4) of this section may be used on processing, alteration, formulation, or the label or in labeling of a meal-type reformulation to lower the caloric con- product as defined in § 317.313(l), pro- tent, it is labeled to clearly refer to all vided that: products of its type and not merely to (i) The product contains at least 25 the particular brand to which the label percent fewer calories per 100 g of prod- attaches. uct than an appropriate reference prod- (3) The terms defined in paragraph uct as described in § 317.313(j)(1); and (b)(2) of this section may be used on (ii) As required in § 317.313(j)(2) for the label or in labeling of a meal-type relative claims: product as defined in § 317.313(l), pro- (A) The identity of the reference vided that: product and the percent (or fraction) (i) The product contains 120 calories that the calories differ between the two or less per 100 g of product; and products are declared in immediate (ii) If the product meets this condi- proximity to the most prominent such tion without the benefit of special claim (e.g., ‘‘calorie reduced ‘product’, processing, alteration, formulation, or 25% less calories per ounce (oz) (or 3 oz) reformulation to lower the calorie con- than our regular ‘product’ ’’); and tent, it is labeled to clearly refer to all (B) Quantitative information com- products of its type and not merely to paring the level of calories in the prod- the particular brand to which it at- uct per specified weight with that of taches. the reference product that it replaces (4) The terms ‘‘reduced calorie,’’ ‘‘re- is declared adjacent to the most promi- duced in calories,’’ ‘‘calorie reduced,’’ nent claim or to the nutrition informa- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or tion (e.g., ‘‘calorie content has been re- ‘‘lower in calories’’ may be used on the duced from 110 calories per 3 oz to 80 label or in labeling of products, except calories per 3 oz’’). meal-type products as defined in (iii) Claims described in paragraph § 317.313(l), provided that: (b)(5) of this section may not be made (i) The product contains at least 25 on the label or in labeling of products percent fewer calories per reference if the reference product meets the defi- amount customarily consumed than an nition for ‘‘low calorie.’’ appropriate reference product as de- (c) Sugar content claims. (1) Terms scribed in § 317.313(j)(1); and such as ‘‘sugar free,’’ ‘‘free of sugar,’’ (ii) As required in § 317.313(j)(2) for ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without relative claims: sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of (A) The identity of the reference sugar,’’ ‘‘negligible source of sugar,’’ or product and the percent (or fraction) ‘‘dietarily insignificant source of that the calories differ between the two sugar’’ may reasonably be expected to products are declared in immediate be regarded by consumers as terms proximity to the most prominent such that represent that the product con- claim (e.g., lower calorie ‘product’— tains no sugars or sweeteners, e.g., ‘‘331⁄3 percent fewer calories than our ‘‘sugar free,’’ or ‘‘no sugar,’’ as indicat- regular ‘product’ ’’); and ing a product which is low in calories (B) Quantitative information com- or significantly reduced in calories. paring the level of calories in the prod- Consequently, except as provided in

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paragraph (c)(2) of this section, a prod- or ‘‘reduced calorie’’ product) and that uct may not be labeled with such terms directs consumers’ attention to the nu- unless: trition panel for further information (i) The product contains less than 0.5 on sugar and calorie content. g of sugars, as defined in (3) Paragraph (c)(1) of this section § 317.309(c)(6)(ii), per reference amount shall not apply to a factual statement customarily consumed and per labeled that a product, including products in- serving size or, in the case of a meal- tended specifically for infants and chil- type product, less than 0.5 g of sugars dren less than 2 years of age, is un- per labeled serving size; sweetened or contains no added sweet- (ii) The product contains no ingredi- eners in the case of a product that con- ent that is a sugar or that is generally tains apparent substantial inherent understood by consumers to contain sugar content, e.g., juices. sugars unless the listing of the ingredi- (4) The terms ‘‘reduced sugar,’’ ‘‘re- ent in the ingredients statement is fol- duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less lowed by an asterisk that refers to the sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in statement below the list of ingredients, sugar’’ may be used on the label or in which states: ‘‘Adds a trivial amount of labeling of products, except meal-type sugar,’’ ‘‘adds a negligible amount of products as defined in § 317.313(l), pro- sugar,’’ or ‘‘adds a dietarily insignifi- vided that: cant amount of sugar;’’ and (i) The product contains at least 25 (iii)(A) It is labeled ‘‘low calorie’’ or percent less sugars per reference ‘‘reduced calorie’’ or bears a relative amount customarily consumed than an claim of special dietary usefulness la- appropriate reference product as de- beled in compliance with paragraphs scribed in § 317.313(j)(1); and (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- (ii) As required in § 317.313(j)(2) for tion; or relative claims: (B) Such term is immediately accom- (A) The identity of the reference panied, each time it is used, by either product and the percent (or fraction) the statement ‘‘not a reduced calorie that the sugars differ between the two product,’’ ‘‘not a low calorie product,’’ products are declared in immediate or ‘‘not for weight control.’’ proximity to the most prominent such (2) The terms ‘‘no added sugar,’’ claim (e.g., ‘‘this product contains 25 ‘‘without added sugar,’’ or ‘‘no sugar percent less sugar than our regular added’’ may be used only if: product’’); and (i) No amount of sugars, as defined in (B) Quantitative information com- § 317.309(c)(6)(ii), or any other ingredi- paring the level of the sugar in the ent that contains sugars that function- product per labeled serving size with ally substitute for added sugars is that of the reference product that it re- added during processing or packaging; places is declared adjacent to the most (ii) The product does not contain an prominent claim or to the nutrition in- ingredient containing added sugars formation (e.g., ‘‘sugar content has such as jam, jelly, or concentrated been lowered from 8 g to 6 g per serv- fruit juice; ing’’). (iii) The sugars content has not been (5) The terms defined in paragraph increased above the amount present in (c)(4) of this section may be used on the the ingredients by some means such as label or in labeling of a meal-type the use of enzymes, except where the product as defined in § 317.313(l), pro- intended functional effect of the proc- vided that: ess is not to increase the sugars con- (i) The product contains at least 25 tent of a product, and a functionally percent less sugars per 100 g of product insignificant increase in sugars results; than an appropriate reference product (iv) The product that it resembles as described in § 317.313(j)(1); and and for which it substitutes normally (ii) As required in § 317.313(j)(2) for contains added sugars; and relative claims: (v) The product bears a statement (A) The identity of the reference that the product is not ‘‘low calorie’’ product and the percent (or fraction) or ‘‘calorie reduced’’ (unless the prod- that the sugars differ between the two uct meets the requirements for a ‘‘low’’ products are declared in immediate

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proximity to the most prominent such tent, it is labeled to clearly refer to all claim (e.g., ‘‘reduced sugar ‘product’— products of its type and not merely to 25% less sugar than our regular ‘prod- the particular brand to which the label uct’ ’’); and attaches. (B) Quantitative information com- (2) The terms ‘‘very low sodium’’ or paring the level of the nutrient in the ‘‘very low in sodium’’ may be used on product per specified weight with that the label or in labeling of products, ex- of the reference product that it re- cept meal-type products as defined in places is declared adjacent to the most § 317.313(l), provided that: prominent claim or to the nutrition in- (i)(A) The product has a reference formation (e.g., ‘‘sugar content has amount customarily consumed greater been reduced from 17 g per 3 oz to 13 g than 30 grams (g) or greater than 2 ta- per 3 oz’’). blespoons (tbsp) and contains 35 mg or [60 FR 191, Jan. 3, 1995] less sodium per reference amount customarily consumed; or § 317.361 Nutrient content claims for (B) The product has a reference the sodium content. amount customarily consumed of 30 g (a) General requirements. A claim or less or 2 tbsp or less and contains 35 about the level of sodium in a product mg or less sodium per reference may only be made on the label or in la- amount customarily consumed and per beling of the product if: 50 g (for dehydrated products that must (1) The claim uses one of the terms be reconstituted before typical con- defined in this section in accordance sumption with water or a diluent con- with the definition for that term; taining an insignificant amount, as de- (2) The claim is made in accordance fined in § 317.309(f)(1), of all nutrients with the general requirements for nu- per reference amount customarily trient content claims in § 317.313; and consumed, the per-50-g criterion refers (3) The product for which the claim is to the ‘‘as prepared’’ form); and made is labeled in accordance with (ii) If the product meets these condi- § 317.309. (b) Sodium content claims. (1) The tions without the benefit of special terms ‘‘sodium free,’’ ‘‘free of sodium,’’ processing, alteration, formulation, or ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without reformulation to lower the sodium con- sodium,’’ ‘‘trivial source of sodium,’’ tent, it is labeled to clearly refer to all ‘‘negligible source of sodium,’’ or products of its type and not merely to ‘‘dietarily insignificant source of so- the particular brand to which the label dium’’ may be used on the label or in attaches. labeling of products, provided that: (3) The terms defined in paragraph (i) The product contains less than 5 (b)(2) of this section may be used on milligrams (mg) of sodium per ref- the label or in labeling of a meal-type erence amount customarily consumed product as defined in § 317.313(l), pro- and per labeled serving size or, in the vided that: case of a meal-type product, less than 5 (i) The product contains 35 mg or less mg of sodium per labeled serving size; of sodium per 100 g of product; and (ii) The product contains no ingredi- (ii) If the product meets this condi- ent that is sodium chloride or is gen- tion without the benefit of special erally understood by consumers to con- processing, alteration, formulation, or tain sodium unless the listing of the in- reformulation to lower the sodium con- gredient in the ingredients statement tent, it is labeled to clearly refer to all is followed by an asterisk that refers to products of its type and not merely to the statement below the list of ingredi- the particular brand to which the label ents, which states: ‘‘Adds a trivial attaches. amount of sodium,’’ ‘‘adds a negligible (4) The terms ‘‘low sodium,’’ ‘‘low in amount of sodium’’ or ‘‘adds a dietarily sodium,’’ ‘‘little sodium,’’ ‘‘contains a insignificant amount of sodium’’; and small amount of sodium,’’ or ‘‘low (iii) If the product meets these condi- source of sodium’’ may be used on the tions without the benefit of special label and in labeling of products, ex- processing, alteration, formulation, or cept meal-type products as defined in reformulation to lower the sodium con- § 317.313(l), provided that:

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(i)(A) The product has a reference two products are declared in imme- amount customarily consumed greater diate proximity to the most prominent than 30 g or greater than 2 tbsp and such claim (e.g., ‘‘reduced sodium contains 140 mg or less sodium per ref- ‘product’, 50 percent less sodium than erence amount customarily consumed; regular ‘product’ ’’); and or (B) Quantitative information com- (B) The product has a reference paring the level of sodium in the prod- amount customarily consumed of 30 g uct per labeled serving size with that of or less or 2 tbsp or less and contains 140 the reference product that it replaces mg or less sodium per reference is declared adjacent to the most promi- amount customarily consumed and per nent claim or to the nutrition informa- 50 g (for dehydrated products that must tion (e.g., ‘‘sodium content has been be reconstituted before typical con- lowered from 300 to 150 mg per serv- sumption with water or a diluent con- ing’’). taining an insignificant amount, as de- (iii) Claims described in paragraph fined in § 317.309(f)(1), of all nutrients (b)(6) of this section may not be made per reference amount customarily on the label or in labeling of a product consumed, the per-50-g criterion refers if the nutrient content of the reference to the ‘‘as prepared’’ form); and product meets the definition for ‘‘low (ii) If the product meets these condi- sodium.’’ tions without the benefit of special (7) The terms defined in paragraph processing, alteration, formulation, or (b)(6) of this section may be used on reformulation to lower the sodium con- the label or in labeling of a meal-type tent, it is labeled to clearly refer to all product as defined in § 317.313(l), pro- products of its type and not merely to vided that: the particular brand to which the label attaches. (i) The product contains at least 25 (5) The terms defined in paragraph percent less sodium per 100 g of product (b)(4) of this section may be used on than an appropriate reference product the label or in labeling of a meal-type as described in § 317.313(j)(1); and product as defined in § 317.313(l), pro- (ii) As required in § 317.313(j)(2) for vided that: relative claims: (i) The product contains 140 mg or (A) The identity of the reference less sodium per 100 g of product; and product and the percent (or fraction) (ii) If the product meets these condi- that the sodium differs between the tions without the benefit of special two products are declared in imme- processing, alteration, formulation, or diate proximity to the most prominent reformulation to lower the sodium con- such claim (e.g., ‘‘reduced sodium tent, it is labeled to clearly refer to all ‘product’—30% less sodium per 3 oz products of its type and not merely to than our ‘regular product’ ’’); and the particular brand to which the label (B) Quantitative information com- attaches. paring the level of sodium in the prod- (6) The terms ‘‘reduced sodium,’’ ‘‘re- uct per specified weight with that of duced in sodium,’’ ‘‘sodium reduced,’’ the reference product that it replaces ‘‘less sodium,’’ ‘‘lower sodium,’’ or is declared adjacent to the most promi- ‘‘lower in sodium’’ may be used on the nent claim or to the nutrition informa- label or in labeling of products, except tion (e.g., ‘‘sodium content has been re- meal-type products as defined in duced from 220 mg per 3 oz to 150 mg § 317.313(l), provided that: per 3 oz’’). (i) The product contains at least 25 (iii) Claims described in paragraph percent less sodium per reference (b)(7) of this section may not be made amount customarily consumed than an on the label or in labeling of products appropriate reference product as de- if the nutrient content of the reference scribed in § 317.313(j)(1); and product meets the definition for ‘‘low (ii) As required in § 317.313(j)(2) for sodium.’’ relative claims: (c) The term ‘‘salt’’ is not synony- (A) The identity of the reference mous with ‘‘sodium.’’ Salt refers to so- product and the percent (or fraction) dium chloride. However, references to that the sodium differs between the salt content such as ‘‘unsalted,’’ ‘‘no

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salt,’’ ‘‘no salt added’’ are potentially serving size or, in the case of a meal- misleading. type product, less than 0.5 g of fat per (1) The term ‘‘salt free’’ may be used labeled serving size; on the label or in labeling of products (ii) The product contains no added in- only if the product is ‘‘sodium free’’ as gredient that is a fat or is generally defined in paragraph (b)(1) of this sec- understood by consumers to contain tion. fat unless the listing of the ingredient (2) The terms ‘‘unsalted,’’ ‘‘without in the ingredients statement is fol- added salt,’’ and ‘‘no salt added’’ may lowed by an asterisk that refers to the be used on the label or in labeling of statement below the list of ingredients, products only if: which states: ‘‘Adds a trivial amount of (i) No salt is added during processing; fat,’’ ‘‘adds a negligible amount of fat,’’ (ii) The product that it resembles and or ‘‘adds a dietarily insignificant for which it substitutes is normally amount of fat’’; and processed with salt; and (iii) If the product meets these condi- (iii) If the product is not sodium free, tions without the benefit of special the statement, ‘‘not a sodium free processing, alteration, formulation, or product’’ or ‘‘not for control of sodium reformulation to lower the fat content, in the diet’’ appears adjacent to the nu- it is labeled to clearly refer to all prod- trition information of the product ucts of its type and not merely to the bearing the claim. particular brand to which the label at- (3) Paragraph (c)(2) of this section taches. shall not apply to a factual statement that a product intended specifically for (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ infants and children less than 2 years ‘‘contains a small amount of fat,’’ ‘‘low of age is unsalted, provided such state- source of fat,’’ or ‘‘little fat’’ may be ment refers to the taste of the product used on the label and in labeling of and is not false or otherwise mislead- products, except meal-type products as ing. defined in § 317.313(l), provided that: (i)(A) The product has a reference [60 FR 192, Jan. 3, 1995] amount customarily consumed greater § 317.362 Nutrient content claims for than 30 g or greater than 2 tablespoons fat, fatty acids, and cholesterol con- (tbsp) and contains 3 g or less of fat per tent. reference amount customarily (a) General requirements. A claim consumed; or about the level of fat, fatty acid, and (B) The product has a reference cholesterol in a product may only be amount customarily consumed of 30 g made on the label or in labeling of or less or 2 tbsp or less and contains 3 products if: g or less of fat per reference amount (1) The claim uses one of the terms customarily consumed and per 50 g (for defined in this section in accordance dehydrated products that must be re- with the definition for that term; constituted before typical consumption (2) The claim is made in accordance with water or a diluent containing an with the general requirements for nu- insignificant amount, as defined in trient content claims in § 317.313; and § 317.309(f)(1), of all nutrients per ref- (3) The product for which the claim is erence amount customarily consumed, made is labeled in accordance with the per-50-g criterion refers to the ‘‘as § 317.309. prepared’’ form). (b) Fat content claims. (1) The terms (ii) If the product meets these condi- ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ tions without the benefit of special ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ processing, alteration, formulation, or ‘‘trivial source of fat,’’ ‘‘negligible reformulation to lower the fat content, source of fat,’’ or ‘‘dietarily insignifi- it is labeled to clearly refer to all prod- cant source of fat’’ may be used on the ucts of its type and not merely to the label or in labeling of products, pro- particular brand to which the label at- vided that: taches. (i) The product contains less than 0.5 (3) The terms defined in paragraph gram (g) of fat per reference amount (b)(2) of this section may be used on customarily consumed and per labeled the label or in labeling of a meal-type

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product as defined in § 317.313(l), pro- (ii) As required in § 317.313(j)(2) for vided that: relative claims: (i) The product contains 3 g or less of (A) The identity of the reference total fat per 100 g of product and not product and the percent (or fraction) more than 30 percent of calories from that the fat differs between the two fat; and products are declared in immediate (ii) If the product meets these condi- proximity to the most prominent such tions without the benefit of special claim (e.g., ‘‘reduced fat ‘product’, 33 processing, alteration, formulation, or percent less fat per 3 oz than our regu- reformulation to lower the fat content, lar ‘product’ ’’); and it is labeled to clearly refer to all prod- (B) Quantitative information com- ucts of its type and not merely to the paring the level of fat in the product particular brand to which the label at- per specified weight with that of the taches. reference product that it replaces is de- (4) The terms ‘‘reduced fat,’’ ‘‘re- clared adjacent to the most prominent duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ such claim or to the nutrition informa- ‘‘lower fat,’’ or ‘‘lower in fat’’ may be tion (e.g., ‘‘fat content has been reused on the label or in labeling of prod- duced from 8 g per 3 oz to 5 g per 3 oz’’). ucts, except meal-type products as de- (iii) Claims described in paragraph fined in § 317.313(l), provided that: (b)(5) of this section may not be made on the label or in labeling of a product (i) The product contains at least 25 if the nutrient content of the reference percent less fat per reference amount product meets the definition for ‘‘low customarily consumed than an appro- fat.’’ priate reference product as described in (6) The term ‘‘lll percent fat free’’ § 317.313(j)(1); and may be used on the label or in labeling (ii) As required in § 317.313(j)(2) for of products, provided that: relative claims: (i) The product meets the criteria for (A) The identity of the reference ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of product and the percent (or fraction) this section; that the fat differs between the two (ii) The percent declared and the products are declared in immediate words ‘‘fat free’’ are in uniform type proximity to the most prominent such size; and claim (e.g., ‘‘reduced fat—50 percent (iii) A ‘‘100 percent fat free’’ claim less fat than our regular ‘product’ ’’); may be made only on products that and meet the criteria for ‘‘fat free’’ in para- (B) Quantitative information com- graph (b)(1) of this section, that con- paring the level of fat in the product tain less than 0.5 g of fat per 100 g, and per labeled serving size with that of the that contain no added fat. reference product that it replaces is de- (iv) A synonym for ‘‘lll percent clared adjacent to the most prominent fat free’’ is ‘‘lll percent lean.’’ claim or to the nutrition information (c) Fatty acid content claims. (1) The (e.g., ‘‘fat content has been reduced terms ‘‘saturated fat free,’’ ‘‘free of from 8 g to 4 g per serving’’). saturated fat,’’ ‘‘no saturated fat,’’ (iii) Claims described in paragraph ‘‘zero saturated fat,’’ ‘‘without satu- (b)(4) of this section may not be made rated fat,’’ ‘‘trivial source of saturated on the label or in labeling of a product fat,’’ ‘‘negligible source of saturated if the nutrient content of the reference fat,’’ or ‘‘dietarily insignificant source product meets the definition for ‘‘low of saturated fat’’ may be used on the fat.’’ label or in labeling of products, pro- (5) The terms defined in paragraph vided that: (b)(4) of this section may be used on (i) The product contains less than 0.5 the label or in labeling of a meal-type g of saturated fat and less than 0.5 g product as defined in § 317.313(l), pro- trans fatty acids per reference amount vided that: customarily consumed and per labeled (i) The product contains at least 25 serving size or, in the case of a meal- percent less fat per 100 g of product type product, less than 0.5 g of satu- than an appropriate reference product rated fat and less than 0.5 g trans fatty as described in § 317.313(j)(1); and acids per labeled serving size;

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(ii) The product contains no ingredi- (4) The terms ‘‘reduced saturated ent that is generally understood by fat,’’ ‘‘reduced in saturated fat,’’ ‘‘satu- consumers to contain saturated fat un- rated fat reduced,’’ ‘‘less saturated less the listing of the ingredient in the fat,’’ ‘‘lower saturated fat,’’ or ‘‘lower ingredients statement is followed by an in saturated fat’’ may be used on the asterisk that refers to the statement label or in labeling of products, except below the list of ingredients, which meal-type products as defined in states: ‘‘Adds a trivial amount of satu- § 317.313(l), provided that: rated fat,’’ ‘‘adds a negligible amount (i) The product contains at least 25 of saturated fat,’’ or ‘‘adds a dietarily percent less saturated fat per reference insignificant amount of saturated fat;’’ amount customarily consumed than an and appropriate reference product as de- (iii) If the product meets these condi- scribed in § 317.313(j)(1); and tions without the benefit of special (ii) As required in § 317.313(j)(2) for processing, alteration, formulation, or relative claims: reformulation to lower saturated fat (A) The identity of the reference content, it is labeled to clearly refer to product and the percent (or fraction) all products of its type and not merely that the saturated fat differs between to the particular brand to which the the two products are declared in imme- label attaches. diate proximity to the most prominent (2) The terms ‘‘low in saturated fat,’’ such claim (e.g., ‘‘reduced saturated fat ‘‘low saturated fat,’’ ‘‘contains a small ‘product’, contains 50 percent less satu- amount of saturated fat,’’ ‘‘low source rated fat than the national average for of saturated fat,’’ or ‘‘a little saturated ‘product’ ’’); and fat’’ may be used on the label or in la- (B) Quantitative information com- beling of products, except meal-type paring the level of saturated fat in the products as defined in § 317.313(l), pro- product per labeled serving size with vided that: that of the reference product that it re- (i) The product contains 1 g or less of places is declared adjacent to the most saturated fat per reference amount cus- prominent claim or to the nutrition in- tomarily consumed and not more than formation (e.g., ‘‘saturated fat reduced 15 percent of calories from saturated from 3 g to 1.5 g per serving’’). fat; and (iii) Claims described in paragraph (ii) If the product meets these condi- (c)(4) of this section may not be made tions without benefit of special proc- on the label or in labeling of a product essing, alteration, formulation, or re- if the nutrient content of the reference formulation to lower saturated fat con- product meets the definition for ‘‘low tent, it is labeled to clearly refer to all saturated fat.’’ products of its type and not merely to (5) The terms defined in paragraph the particular brand to which the label (c)(4) of this section may be used on the attaches. label or in labeling of a meal-type (3) The terms defined in paragraph product as defined in § 317.313(l), pro- (c)(2) of this section may be used on the vided that: label or in labeling of a meal-type (i) The product contains at least 25 product as defined in § 317.313(l), pro- percent less saturated fat per 100 g of vided that: product than an appropriate reference (i) The product contains 1 g or less of product as described in § 317.313(j)(1); saturated fat per 100 g and less than 10 and percent calories from saturated fat; (ii) As required in § 317.313(j)(2) for and relative claims: (ii) If the product meets these condi- (A) The identity of the reference tions without the benefit of special product and the percent (or fraction) processing, alteration, formulation, or that the saturated fat differs between reformulation to lower saturated fat the two products are declared in imme- content, it is labeled to clearly refer to diate proximity to the most prominent all products of its type and not merely such claim (e.g., ‘‘reduced saturated fat to the particular brand to which the ‘product’,’’ ‘‘50 percent less saturated label attaches. fat than our regular ‘product’ ’’); and

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(B) Quantitative information com- formulation, the amount of cholesterol paring the level of saturated fat in the is reduced by 25 percent or more from product per specified weight with that the reference product it replaces as de- of the reference product that it re- scribed in § 317.313(j)(1) and for which it places is declared adjacent to the most substitutes as described in § 317.313(d) prominent claim or to the nutrition in- that has a significant (e.g., 5 percent or formation (e.g., ‘‘saturated fat content more of a national or regional market) has been reduced from 2.5 g per 3 oz to market share. As required in 1.5 g per 3 oz’’). § 317.313(j)(2) for relative claims: (iii) Claims described in paragraph (A) The identity of the reference (c)(5) of this section may not be made product and the percent (or fraction) on the label or in labeling of a product that the cholesterol was reduced are if the nutrient content of the reference declared in immediate proximity to the product meets the definition for ‘‘low most prominent such claim (e.g., ‘‘cho- saturated fat.’’ lesterol free ‘product’, contains 100 per- (d) Cholesterol content claims. (1) The cent less cholesterol than ‘reference terms ‘‘cholesterol free,’’ ‘‘free of cho- product’ ’’); and lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without (B) Quantitative information com- cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial paring the level of cholesterol in the source of cholesterol,’’ ‘‘negligible product per labeled serving size with source of cholesterol,’’ or ‘‘dietarily in- that of the reference product that it re- significant source of cholesterol’’ may places is declared adjacent to the most be used on the label or in labeling of prominent claim or to the nutrition in- products, provided that: formation (e.g., ‘‘contains no choles- (i) The product contains less than 2 terol compared with 30 mg in one serv- milligrams (mg) of cholesterol per ref- ing of ‘reference product’ ’’). erence amount customarily consumed (2) The terms ‘‘low in cholesterol,’’ and per labeled serving size or, in the ‘‘low cholesterol,’’ ‘‘contains a small case of a meal-type product as defined amount of cholesterol,’’ ‘‘low source of in § 317.313(l), less than 2 mg of choles- cholesterol,’’ or ‘‘little cholesterol’’ terol per labeled serving size; may be used on the label or in labeling (ii) The product contains no ingredi- of products, except meal-type products ent that is generally understood by as defined in § 317.313(l), provided that: consumers to contain cholesterol, un- (i)(A) If the product has a reference less the listing of the ingredient in the amount customarily consumed greater ingredients statement is followed by an than 30 g or greater than 2 tbsp: asterisk that refers to the statement (1) The product contains 20 mg or less below the list of ingredients, which of cholesterol per reference amount states: ‘‘Adds a trivial amount of cho- customarily consumed; and lesterol,’’ ‘‘adds a negligible amount of (2) The product contains 2 g or less of cholesterol,’’ or ‘‘adds a dietarily insig- saturated fat per reference amount cus- nificant amount of cholesterol’’; tomarily consumed; or (iii) The product contains 2 g or less (B) If the product has a reference of saturated fat per reference amount amount customarily consumed of 30 g customarily consumed or, in the case or less or 2 tbsp or less: of a meal-type product as defined in (1) The product contains 20 mg or less § 317.313(l), 2 g or less of saturated fat of cholesterol per reference amount per labeled serving size; and customarily consumed and per 50 g (for (iv) If the product meets these condi- dehydrated products that must be re- tions without the benefit of special constituted before typical consumption processing, alteration, formulation, or with water or a diluent containing an reformulation to lower cholesterol con- insignificant amount, as defined in tent, it is labeled to clearly refer to all § 317.309(f)(1), of all nutrients per ref- products of its type and not merely to erence amount customarily consumed, the particular brand to which it at- the per-50-g criterion refers to the ‘‘as taches; or prepared’’ form); and (v) If the product meets these condi- (2) The product contains 2 g or less of tions only as a result of special proc- saturated fat per reference amount cus- essing, alteration, formulation, or re- tomarily consumed.

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(ii) If the product meets these condi- may be used on the label or in labeling tions without the benefit of special of products or products that substitute processing, alteration, formulation, or for those products as specified in reformulation to lower cholesterol con- § 317.313(d), excluding meal-type prod- tent, it is labeled to clearly refer to all ucts as defined in § 317.313(l), provided products of its type and not merely to that: the particular brand to which the label (i) The product has been specifically attaches; or formulated, altered, or processed to re- (iii) If the product contains 20 mg or duce its cholesterol by 25 percent or less of cholesterol only as a result of more from the reference product it re- special processing, alteration, formula- places as described in § 317.313(j)(1) and tion, or reformulation, the amount of for which it substitutes as described in cholesterol is reduced by 25 percent or § 317.313(d) that has a significant (e.g., 5 more from the reference product it re- percent or more of a national or replaces as described in § 317.313(j)(1) and gional market) market share; for which it substitutes as described in (ii) The product contains 2 g or less § 317.313(d) that has a significant (e.g., 5 of saturated fat per reference amount percent or more of a national or re- customarily consumed; and gional market) market share. As re- (iii) As required in § 317.313(j)(2) for quired in § 317.313(j)(2) for relative relative claims: claims: (A) The identity of the reference (A) The identity of the reference product and the percent (or fraction) product and the percent (or fraction) that the cholesterol has been reduced that the cholesterol has been reduced are declared in immediate proximity to are declared in immediate proximity to the most prominent such claim (e.g., the most prominent such claim (e.g., ‘‘low cholesterol ‘product’, contains 85 ‘‘25 percent less cholesterol than ‘ref- percent less cholesterol than our regu- erence product’ ’’); and lar ‘product’ ’’); and (B) Quantitative information com- (B) Quantitative information comparing the level of cholesterol in the paring the level of cholesterol in the product per labeled serving size with product per labeled serving size with that of the reference product that it re- that of the reference product that it replaces is declared adjacent to the most places is declared adjacent to the most prominent claim or to the nutrition in- prominent claim or to the nutrition information (e.g., ‘‘cholesterol lowered formation (e.g., ‘‘cholesterol lowered from 55 mg to 30 mg per serving’’). from 30 mg to 5 mg per serving’’). (iv) Claims described in paragraph (3) The terms defined in paragraph (d)(4) of this section may not be made (d)(2) of this section may be used on on the label or in labeling of a product the label or in labeling of a meal-type if the nutrient content of the reference product as defined in § 317.313(l), pro- product meets the definition for ‘‘low vided that: cholesterol.’’ (i) The product contains 20 mg or less (5) The terms defined in paragraph of cholesterol per 100 g of product; (d)(4) of this section may be used on (ii) The product contains 2 g or less the label or in labeling of a meal-type of saturated fat per 100 g of product; product as defined in § 317.313(l), pro- and vided that: (iii) If the product meets these condi- (i) The product has been specifically tions without the benefit of special formulated, altered, or processed to reprocessing, alteration, formulation, or duce its cholesterol by 25 percent or reformulation to lower cholesterol con- more from the reference product it re- tent, it is labeled to clearly refer to all places as described in § 317.313(j)(1) and products of its type and not merely to for which it substitutes as described in the particular brand to which the label § 317.313(d) that has a significant (e.g., 5 attaches. percent or more of a national or re- (4) The terms ‘‘reduced cholesterol,’’ gional market) market share; ‘‘reduced in cholesterol,’’ ‘‘cholesterol (ii) The product contains 2 g or less reduced,’’ ‘‘less cholesterol,’’ ‘‘lower of saturated fat per 100 g of product; cholesterol,’’ or ‘‘lower in cholesterol’’ and

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(iii) As required in § 317.313(j)(2) for saturated fat,’’ as defined in § 317.362, relative claims: except that single-ingredient, raw (A) The identity of the reference products may meet the total fat and product and the percent (or fraction) saturated fat criteria for ‘‘extra lean’’ that the cholesterol has been reduced in § 317.362. are declared in immediate proximity to (2) The product shall not contain the most prominent such claim (e.g., more than 60 milligrams (mg) of cho- ‘‘25% less cholesterol than ‘reference lesterol per reference amount cus- product’ ’’); and tomarily consumed, per labeled serving (B) Quantitative information com- size, and, only for foods with reference paring the level of cholesterol in the amounts customarily consumed of 30 product per specified weight with that of the reference product that it re- grams (g) or less or 2 tablespoons (tbsp) places is declared adjacent to the most or less, per 50 g, and, for dehydrated prominent claim or to the nutrition in- products that must be reconstituted formation (e.g., ‘‘cholesterol content with water or a diluent containing an has been reduced from 35 mg per 3 oz to insignificant amount, as defined in 25 mg per 3 oz). § 317.309(f)(1), of all nutrients, the per- (iv) Claims described in paragraph 50-g criterion refers to the prepared (d)(5) of this section may not be made form, except that: on the label or in labeling of a product (i) A meal-type product, as defined in if the nutrient content of the reference § 317.313(l), and including meal-type product meets the definition for ‘‘low products that weigh more than 12 cholesterol.’’ ounces (oz) per serving (container), (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. shall not contain more than 90 mg of (1) The term ‘‘lean’’ may be used on the cholesterol per labeled serving size; label or in labeling of a product, pro- and vided that the product contains less (ii) Single-ingredient, raw products than 10 g of fat, 4.5 g or less of satu- may meet the cholesterol criterion for rated fat, and less than 95 mg of choles- ‘‘extra lean’’in § 317.362. terol per 100 g of product and per ref- (3) The product shall not contain erence amount customarily consumed for individual foods, and per 100 g of more than 360 mg of sodium, except product and per labeled serving size for that it shall not contain more than 480 meal-type products as defined in mg of sodium during the first 24 § 317.313(l). months of implementation, per ref- (2) The term ‘‘extra lean’’ may be erence amount customarily consumed, used on the label or in labeling of a per labeled serving size, and, only for product, provided that the product con- foods with reference amounts cus- tains less than 5 g of fat, less than 2 g tomarily consumed of 30 g or less or 2 of saturated fat, and less than 95 mg of tbsp or less, per 50 g, and, for dehy- cholesterol per 100 g of product and per drated products that must be reconsti- reference amount customarily tuted with water or a diluent contain- consumed for individual foods, and per ing an insignificant amount, as defined 100 g of product and per labeled serving in § 317.309(f)(1), of all nutrients, the size for meal-type products as defined per-50-g criterion refers to the prepared in § 317.313(l). form, except that: [60 FR 193, Jan. 3, 1995] (i) A meal-type product, as defined in § 317.313(l), and including meal-type § 317.363 Nutrient content claims for products that weigh more than 12 oz ‘‘healthy.’’ per serving (container), shall not con- (a) The term ‘‘healthy,’’ or any other tain more than 480 mg of sodium, ex- derivative of the term ‘‘health,’’ may cept that it shall not contain more be used on the labeling of any meat or than 600 mg of sodium during the first meat food product, provided that the 24 months of implementation, per la- product is labeled in accordance with beled serving size; and § 317.309 and § 317.313. (ii) The requirements of this para- (b)(1) The product shall meet the re- graph (b)(3) do not apply to single-in- quirements for ‘‘low fat’’ and ‘‘low gredient, raw products.

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(4) The product shall contain 10 per- information submitted to and retained cent or more of the Reference Daily In- in the files of the Food Safety and In- take or Daily Reference Value as de- spection Service. However, any ref- fined in § 317.309 for vitamin A, vitamin erence to unpublished information fur- C, iron, calcium, protein, or fiber per nished by a person other than the ap- reference amount customarily plicant will not be considered unless consumed prior to any nutrient addi- use of such information is authorized tion, except that: (with the understanding that such in- (i) A meal-type product, as defined in formation may in whole or part be sub- § 317.313(l), and including meal-type ject to release to the public) in a writ- products that weigh at least 6 oz but ten statement signed by the person less than 10 oz per serving (container), who submitted it. Any reference to shall meet the level for two of the nu- published information should be ac- trients per labeled serving size; and companied by reprints or photostatic (ii) A meal-type product, as defined copies of such references. in § 317.313(l), and including meal-type (e) If nonclinical laboratory studies products that weigh 10 oz or more per accompany a labeling application, the serving (container), shall meet the applicant shall include, with respect to level for three of the nutrients per la- each nonclinical study included with beled serving size. the application, either a statement [59 FR 24228, May 10, 1994, as amended at 60 that the study has been, or will be, FR 196, Jan. 3, 1995] conducted in compliance with the good laboratory practice regulations as set §§ 317.364–317.368 [Reserved] forth in part 58 of chapter 1, title 21, or, if any such study was not conducted in § 317.369 Labeling applications for nutrient content claims. compliance with such regulations, a brief statement of the reason for the (a) This section pertains to labeling noncompliance. applications for claims, express or im- (f) If clinical investigations accom- plied, that characterize the level of any pany a labeling application, the appli- nutrient required to be on the label or cant shall include, with respect to each in labeling of product by this subpart. clinical investigation included with the (b) Labeling applications included in application, either a statement that this section are: the investigation was conducted in (1) Labeling applications for a new compliance with the requirements for (heretofore unauthorized) nutrient con- institutional review set forth in part 56 tent claim, of chapter 1, title 21, or was not subject (2) Labeling applications for a synonymous term (i.e., one that is consist- to such requirements in accordance ent with a term defined by regulation) with § 56.194 or § 56.105, and that it was for characterizing the level of a nutri- conducted in compliance with the re- ent, and quirements for informed consents set (3) Labeling applications for the use forth in part 50 of chapter 1, title 21. of an implied claim in a brand name. (g) The availability for public disclo- (c) Labeling applications and sup- sure of labeling applications, along porting documentation to be filed with supporting documentation, sub- under this section shall be submitted mitted to the Agency under this sec- in quadruplicate, except that the sup- tion will be governed by the rules spec- porting documentation may be submit- ified in subchapter D, title 9. ted on a computer disc copy. If any (h) The data specified under this sec- part of the material submitted is in a tion to accompany a labeling applica- foreign language, it shall be accom- tion shall be submitted on separate panied by an accurate and complete sheets, suitably identified. If such data English translation. The labeling appli- has already been submitted with an cation shall state the applicant’s post earlier labeling application from the office address. applicant, the present labeling applica- (d) Pertinent information will be tion must provide the data. considered as part of an application on (i) The labeling application must be the basis of specific reference to such signed by the applicant or by his or her

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attorney or agent, or (if a corporation) pected to understand the meaning of the by an authorized official. term under the proposed conditions of use. (j) The labeling application shall in- (iii) Analytical data that demonstrates the amount of the nutrient that is present in the clude a statement signed by the person products for which the claim is intended. responsible for the labeling applica- The assays should be performed on rep- tion, that to the best of his or her resentative samples in accordance with knowledge, it is a representative and 317.309(h). If no USDA or AOAC methods are balanced submission that includes un- available, the applicant shall submit the favorable information, as well as favor- assay method used, and data establishing the able information, known to him or her validity of the method for assaying the nu- pertinent to the evaluation of the la- trient in the particular food. The validation data shall include a statistical analysis of beling application. the analytical and product variability. (k)(1) Labeling applications for a new (iv) A detailed analysis of the potential ef- nutrient content claim shall be accom- fect of the use of the proposed claim on food panied by the following data which consumption, and any corresponding changes shall be submitted in the following in nutrient intake. The analysis shall spe- form to the Director, Food Labeling cifically address the intake of nutrients that Division, Regulatory Programs, Food have beneficial and negative consequences in the total diet. If the claim is intended for a Safety and Inspection Service, Wash- specific group within the population, the ington, DC 20250. analysis shall specifically address the die- ———————————————————————— tary practices of such group, and shall include data sufficient to demonstrate that the (Date) dietary analysis is representative of such The undersigned, lllll, submits this group. labeling application pursuant to 9 CFR Yours very truly, 317.369 with respect to (statement of the claim and its proposed use). Applicant ——————————————— Attached hereto, in quadruplicate, or on a By ——————————————————— computer disc copy, and constituting a part (Indicate authority) of this labeling application, are the follow- (2) Upon receipt of the labeling appli- ing: (i) A statement identifying the nutrient cation and supporting documentation, content claim and the nutrient that the the applicant shall be notified, in writ- term is intended to characterize with respect ing, of the date on which the labeling to the level of such nutrient. The statement application was received. Such notice shall address why the use of the term as pro- shall inform the applicant that the la- posed will not be misleading. The statement beling application is undergoing Agen- shall provide examples of the nutrient con- cy review and that the applicant shall tent claim as it will be used on labels or la- subsequently be notified of the Agen- beling, as well as the types of products on cy’s decision to consider for further re- which the claim will be used. The statement shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels the Agency shall notify the applicant, or labeling, as well as any factors that would in writing, that the labeling applica- make the use of the term inappropriate. tion is either being considered for fur- (ii) A detailed explanation supported by ther review or that it has been sum- any necessary data of why use of the food marily denied by the Administrator. component characterized by the claim is of (4) If the labeling application is sum- importance in human nutrition by virtue of its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to reasons therefor, including why the the public will derive from use of the claim Agency has determined that the pro- as proposed and why such benefit is not posed nutrient content claim is false or available through the use of existing terms misleading. The notification letter defined by regulation. If the claim is in- shall inform the applicant that the ap- tended for a specific group within the popu- plicant may submit a written state- lation, the analysis shall specifically address nutritional needs of such group, and sci- ment by way of answer to the notifica- entific data sufficient for such purpose, and tion, and that the applicant shall have data and information to the extent necessary the right to request a hearing with re- to demonstrate that consumers can be ex- spect to the merits or validity of the

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Administrator’s decision to deny the termined by the Agency to be false or use of the proposed nutrient content misleading. The notification letter claim. shall also inform the applicant that the (i) If the applicant fails to accept the applicant may submit a written state- determination of the Administrator ment by way of answer to the notifica- and files an answer and requests a tion, and that the applicant shall have hearing, and the Administrator, after the right to request a hearing with re- review of the answer, determines the spect to the merits or validity of the initial determination to be correct, the Administrator’s decision to deny the Administrator shall file with the Hear- use of the proposed nutrient content ing Clerk of the Department the notifi- claim. cation, answer, and the request for a (A) If the applicant fails to accept hearing, which shall constitute the the determination of the Adminis- complaint and answer in the proceed- trator and files an answer and requests ing, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall constitute the shall make the final determination for complaint and answer in the proceed- the Secretary. Any such determination by the Secretary shall be conclusive ing, which shall thereafter be con- unless, within 30 days after receipt of ducted in accordance with the Depart- notice of such final determination, the ment’s Uniform Rules of Practice. applicant appeals to the United States (B) The hearing shall be conducted Court of Appeals for the circuit in before an administrative law judge which the applicant has its principal with the opportunity for appeal to the place of business or to the United Department’s Judicial Officer, who States Court of Appeals for the District shall make final determination for the of Columbia Circuit. Secretary. Any such determination by (5) If the labeling application is not the Secretary shall be conclusive un- summarily denied by the Adminis- less, within 30 days after receipt of the trator, the Administrator shall publish notice of such final determination, the in the FEDERAL REGISTER a proposed applicant appeals to the United States rule to amend the regulations to au- Court of Appeals for the circuit in thorize the use of the nutrient content which the applicant has its principal claim. The proposal shall also summa- place of business or to the United rize the labeling application, including States Court of Appeals for the District where the supporting documentation of Columbia Circuit. can be reviewed. The Administrator’s (ii) If the claim is approved, the proposed rule shall seek comment from Agency shall notify the applicant, in consumers, the industry, consumer and writing, and shall also publish in the industry groups, and other interested FEDERAL REGISTER a final rule amend- persons on the labeling application and ing the regulations to authorize the the use of the proposed nutrient con- use of the claim. tent claim. After public comment has (l)(1) Labeling applications for a syn- been received and reviewed by the onymous term shall be accompanied by Agency, the Administrator shall make the following data which shall be sub- a determination on whether the pro- mitted in the following form to the Di- posed nutrient content claim shall be rector, Food Labeling Division, Regu- approved for use on the labeling of latory Programs, Food Safety and In- meat and meat food products. spection Service, Washington, DC 20250: (i) If the claim is denied by the Ad- ministrator, the Agency shall notify ———————————————————————— the applicant, in writing, of the basis (Date) for the denial, including the reason The undersigned, llllll submits this why the claim on the labeling was de- labeling application pursuant to 9 CFR

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317.369 with respect to (statement of the syn- ther review or that it has been sum- onymous term and its proposed use in a nu- marily denied by the Administrator. trient content claim that is consistent with (4) If the labeling application is sum- an existing term that has been defined under subpart B of part 317). marily denied by the Administrator, Attached hereto, in quadruplicate, or on a the written notification shall state the computer disc copy, and constituting a part reasons therefor, including why the of this labeling application, are the follow- Agency has determined that the pro- ing: posed synonymous term is false or mis- (i) A statement identifying the synony- leading. The notification letter shall mous term, the existing term defined by a inform the applicant that the applicant regulation with which the synonymous term is claimed to be consistent, and the nutrient may submit a written statement by that the term is intended to characterize the way of answer to the notification, and level of. The statement shall address why the that the applicant shall have the right use of the synonymous term as proposed will to request a hearing with respect to not be misleading. The statement shall pro- the merits or validity of the Adminis- vide examples of the nutrient content claim trator’s decision to deny the use of the as it will be used on labels or labeling, as proposed synonymous term. well as the types of products on which the (i) If the applicant fails to accept the claim will be used. The statement shall also specify whether any limitations not applica- determination of the Administrator ble to the use of the defined term are in- and files an answer and requests a tended to apply to the use of the synony- hearing, and the Administrator, after mous term. review of the answer, determines the (ii) A detailed explanation supported by initial determination to be correct, the any necessary data of why use of the pro- Administrator shall file with the Hear- posed term is requested, including whether ing Clerk of the Department the notifi- the existing defined term is inadequate for the purpose of effectively characterizing the cation, answer, and the request for a level of a nutrient. This explanation shall hearing, which shall constitute the also state what nutritional benefit to the complaint and answer in the proceed- public will derive from use of the claim as ing, which shall thereafter be con- proposed, and why such benefit is not avail- ducted in accordance with the Depart- able through the use of existing terms de- ment’s Uniform Rules of Practice. fined by regulation. If the claim is intended (ii) The hearing shall be conducted for a specific group within the population, the analysis shall specifically address nutri- before an administrative law judge tional needs of such group, scientific data with the opportunity for appeal to the sufficient for such purpose, and data and in- Department’s Judicial Officer, who formation to the extent necessary to dem- shall make the final determination for onstrate that consumers can be expected to the Secretary. Any such determination understand the meaning of the term under by the Secretary shall be conclusive the proposed conditions of use. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant ——————————————— applicant appeals to the United States By ——————————————————— Court of Appeals for the circuit in (Indicate authority) which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL beling application is undergoing Agen- REGISTER a notice informing the public cy review and that the applicant shall that the synonymous term has been ap- subsequently be notified of the Agen- proved for use. cy’s decision to consider for further re- (m)(1) Labeling applications for the view or deny the labeling application. use of an implied nutrient content (3) Upon review of the labeling appli- claim in a brand name shall be accom- cation and supporting documentation, panied by the following data which the Agency shall notify the applicant, shall be submitted in the following in writing, that the labeling applica- form to the Director, Food Labeling tion is either being considered for fur- Division, Regulatory Programs, Food

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Safety and Inspection Service, Wash- ther review or that it has been sum- ington, DC 20250: marily denied by the Administrator. (4) If the labeling application is sum- ———————————————————————— (Date) marily denied by the Administrator, the written notification shall state the The undersigned, llllll submits this labeling application pursuant to 9 CFR reasons therefor, including why the 317.369 with respect to (statement of the im- Agency has determined that the pro- plied nutrient content claim and its proposed posed implied nutrient content claim is use in a brand name). false or misleading. The notification Attached hereto, in quadruplicate, or on a letter shall inform the applicant that computer disc copy, and constituting a part the applicant may submit a written of this labeling application, are the follow- statement by way of answer to the no- ing: tification, and that the applicant shall (i) A statement identifying the implied nutrient content claim, the nutrient the claim have the right to request a hearing is intended to characterize, the correspond- with respect to the merits or validity ing term for characterizing the level of such of the Administrator’s decision to deny nutrient as defined by a regulation, and the the use of the proposed implied nutri- brand name of which the implied claim is in- ent content claim. tended to be a part. The statement shall ad- (i) If the applicant fails to accept the dress why the use of the brand-name as pro- determination of the Administrator posed will not be misleading. The statement and files an answer and requests a shall provide examples of the types of products on which the brand name will appear. It hearing, and the Administrator, after shall also include data showing that the ac- review of the answer, determines the tual level of the nutrient in the food would initial determination to be correct, the qualify the label of the product to bear the Administrator shall file with the Hear- corresponding term defined by regulation. ing Clerk of the Department the notifi- Assay methods used to determine the level of cation, answer, and the request for a a nutrient shall meet the requirements stat- hearing, which shall constitute the ed under labeling application format in para- complaint and answer in the proceed- graph (k)(1)(iii) of this section. (ii) A detailed explanation supported by ing, which shall thereafter be con- any necessary data of why use of the pro- ducted in accordance with the Depart- posed brand name is requested. This expla- ment’s Uniform Rules of Practice. nation shall also state what nutritional ben- (ii) The hearing shall be conducted efit to the public will derive from use of the before an administrative law judge brand name as proposed. If the branded prod- with the opportunity for appeal to the uct is intended for a specific group within Department’s Judicial Officer, who the population, the analysis shall specifi- shall make the final determination for cally address nutritional needs of such group and scientific data sufficient for such pur- the Secretary. Any such determination pose. by the Secretary shall be conclusive Yours very truly, unless, within 30 days after receipt of notice of such final determination, the Applicant ——————————————— applicant appeals to the United States By ——————————————————— Court of Appeals for the circuit in (2) Upon receipt of the labeling appli- which the applicant has its principal cation and supporting documentation, place of business or to the United the applicant shall be notified, in writ- States Court of Appeals for the District ing, of the date on which the labeling of Columbia Circuit. application was received. Such notice (5) If the labeling application is not shall inform the applicant that the la- summarily denied by the Adminis- beling application is undergoing Agen- trator, the Administrator shall publish cy review and that the applicant shall a notice of the labeling application in subsequently be notified of the Agen- the FEDERAL REGISTER seeking com- cy’s decision to consider for further re- ment on the use of the implied nutrient view or deny the labeling application. content claim. The notice shall also (3) Upon review of the labeling appli- summarize the labeling application, in- cation and supporting documentation, cluding where the supporting docu- the Agency shall notify the applicant, mentation can be reviewed. The Ad- in writing, that the labeling applica- ministrator’s notice shall seek com- tion is either being considered for fur- ment from consumers, the industry,

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consumer and industry groups, and content claim has been approved for other interested persons on the label- use. ing application and the use of the im- (Paperwork requirements were approved by plied nutrient content claim. After the Office of Management and Budget under public comment has been received and control number 0583–0088) reviewed by the Agency, the Adminis- [58 FR 664, Jan. 6, 1993, as amended at 59 FR trator shall make a determination on 45196, Sept. 1, 1994; 60 FR 196, Jan. 3, 1995] whether the implied nutrient content claim shall be approved for use on the §§ 317.370–317.379 [Reserved] labeling of meat food products. § 317.380 Label statements relating to (i) If the claim is denied by the Ad- usefulness in reducing or maintain- ministrator, the Agency shall notify ing body weight. the applicant, in writing, of the basis for the denial, including the reason (a) General requirements. Any product why the claim on the labeling was de- that purports to be or is represented termined by the Agency to be false or for special dietary use because of use- misleading. The notification letter fulness in reducing body weight shall shall also inform the applicant that the bear: applicant may submit a written state- (1) Nutrition labeling in conformity ment by way of answer to the notifica- with § 317.309 of this subpart, unless ex- tion, and that the applicant shall have empt under that section, and the right to request a hearing with re- (2) A conspicuous statement of the spect to the merits or validity of the basis upon which the product claims to Administrator’s decision to deny the be of special dietary usefulness. use of the proposed implied nutrient (b) Nonnutritive ingredients. (1) Any content claim. product subject to paragraph (a) of this (A) If the applicant fails to accept section that achieves its special die- the determination of the Adminis- tary usefulness by use of a nonnutri- trator and files an answer and requests tive ingredient (i.e., one not utilized in a hearing, and the Administrator, after normal metabolism) shall bear on its review of the answer, determines the label a statement that it contains a initial determination to be correct, the nonnutritive ingredient and the per- Administrator shall file with the Hear- centage by weight of the nonnutritive ing Clerk of the Department the notifi- ingredient. cation, answer, and the request for a (2) A special dietary product may hearing, which shall thereafter be con- contain a nonnutritive sweetener or ducted in accordance with the Depart- other ingredient only if the ingredient ment’s Uniform Rules of Practice. is safe for use in the product under the (B) The hearing shall be conducted applicable law and regulations of this before an administrative law judge chapter. Any product that achieves its with the opportunity for appeal to the Department’s Judicial Officer, who special dietary usefulness in reducing shall make the final determination for or maintaining body weight through the Secretary. Any such determination the use of a nonnutritive sweetener by the Secretary shall be conclusive shall bear on its label the statement unless, within 30 days after receipt of required by paragraph (b)(1) of this sec- the notice of such final determination, tion, but need not state the percentage the applicant appeals to the United by weight of the nonnutritive sweet- States Court of Appeals for the circuit ener. If a nutritive sweetener(s) as well in which the applicant has its principal as nonnutritive sweetener(s) is added, place of business or to the United the statement shall indicate the pres- States Court of Appeals for the District ence of both types of sweetener; e.g., of Columbia Circuit. ‘‘Sweetened with nutritive sweetener(s) (ii) If the claim is approved, the and nonnutritive sweetener(s).’’ Agency shall notify the applicant, in (c) ‘‘Low calorie’’ foods. A product writing, and shall also publish in the purporting to be ‘‘low calorie’’ must FEDERAL REGISTER a notice informing comply with the criteria set forth for the public that the implied nutrient such foods in § 317.360.

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(d) ‘‘Reduced calorie’’ foods and other (i) A food product, for the purposes of comparative claims. A product purport- the small business exemption, is de- ing to be ‘‘reduced calorie’’ or other- fined as a formulation, not including wise containing fewer calories than a distinct flavors which do not signifi- reference food must comply with the cantly alter the nutritional profile, criteria set forth for such foods in sold in any size package in commerce. § 317.360(b) (4) and (5). (ii) For purposes of this paragraph, a (e) ‘‘Label terms suggesting usefulness small business is any single-plant facil- as low calorie or reduced calorie foods’’. ity or multi-plant company/firm that (1) Except as provided in paragraphs employs 500 or fewer people and pro- (e)(2) and (e)(3) of this section, a prod- duces no more than the following uct may be labeled with terms such as amounts of pounds of the product ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- qualifying the firm for exemption from ened,’’ or ‘‘sweetened with nonnutri- this subpart: tive sweetener’’ only if the claim is not (A) During the first year of imple- false or misleading, and the product is mentation of nutrition labeling, from labeled ‘‘low calorie’’ or ‘‘reduced cal- July 1994 to July 1995, 250,000 pounds or orie’’ or bears another comparative cal- less, orie claim in compliance with the ap- (B) During the second year of imple- plicable provisions in this subpart. mentation of nutrition labeling, from (2) Paragraph (e)(1) of this section July 1995 to July 1996, 175,000 pounds or shall not apply to any use of such less, and terms that is specifically authorized by (C) During the third year of imple- regulation governing a particular food, mentation and subsequent years there- or, unless otherwise restricted by regu- after, 100,000 pounds or less. lation, to any use of the term ‘‘diet’’ (iii) For purposes of this paragraph, that clearly shows that the product is calculation of the amount of pounds shall be based on the most recent 2- offered solely for a dietary use other year average of business activity. than regulating body weight, e.g., ‘‘for Where firms have been in business less low sodium diets.’’ than 2 years or where products have (3) Paragraph (e)(1) of this section been produced for less than 2 years, shall not apply to any use of such reasonable estimates must indicate terms on a formulated meal replace- that the annual pounds produced will ment or other product that is rep- not exceed the amounts specified. resented to be of special dietary use as (2) Products intended for further a whole meal, pending the issuance of a processing, provided that the labels for regulation governing the use of such these products bear no nutrition claim terms on foods. or nutrition information, (f) ‘‘Sugar free’’ and ‘‘no added sugar’’. (3) Products that are not for sale to Criteria for the use of the terms ‘‘sugar consumers, provided that the labels for free’’ and ‘‘no added sugar’’ are pro- these products bear no nutrition claims vided for in § 317.360(c). or nutrition information, [58 FR 664, Jan. 6, 1993; 58 FR 43788, Aug. 18, (4) Products in small packages that 1993, as amended at 58 FR 47627, Sept. 10, are individually wrapped packages of 1993; 58 FR 66075, Dec. 17, 1993; 60 FR 196, Jan. less than 1⁄2 ounce net weight, provided 3, 1995] that the labels for these products bear no nutrition claims or nutrition infor- §§ 317.381–317.399 [Reserved] mation, (5) Products custom slaughtered or § 317.400 Exemption from nutrition la- prepared, beling. (6) Products intended for export, and (a) The following meat or meat food (7) The following products prepared products are exempt from nutrition la- and served or sold at retail provided beling: that the labels or the labeling of these (1) Food products produced by small products bear no nutrition claims or businesses provided that the labels for nutrition information: these products bear no nutrition claims (i) Ready-to-eat products that are or nutrition information, packaged or portioned at a retail store

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or similar retail-type establishment; quired information shall be in a type and size no smaller than 6 point or all (ii) Multi-ingredient products (e.g., upper case type of 1⁄16-inch minimum sausage) processed at a retail store or height, except that individual serving- similar retail-type establishment. size packages of meat products that (b) Restaurant menus generally do have a total area available to bear la- not constitute labeling or fall within beling of 3 square inches or less may the scope of these regulations. provide all required information in a (c)(1) Foods represented to be specifi- type size no smaller than 1⁄32-inch mini- cally for infants and children less than mum height. 2 years of age shall bear nutrition la- [58 FR 664, Jan. 6, 1993, as amended at 58 FR beling as provided in paragraph (c)(2) of 47627, Sept. 10, 1993; 59 FR 45196, Sept. 1, 1994; this section, except such labeling shall 60 FR 196, Jan. 3, 1995] not include calories from fat, calories from saturated fat, saturated fat, stearic acid, polyunsaturated fat, PART 318—ENTRY INTO OFFICIAL monounsaturated fat, and cholesterol. ESTABLISHMENTS; REINSPECTION (2) Foods represented or purported to AND PREPARATION OF PROD- be specifically for infants and children UCTS less than 4 years of age shall bear nutrition labeling except that: Subpart A—General (i) Such labeling shall not include declarations of percent of Daily Value Sec. 318.1 Products and other articles entering for total fat, saturated fat, cholesterol, official establishments. sodium, potassium, total carbohydrate, 318.2 Reinspection, retention, and disposal and dietary fiber; of meat and poultry products at official (ii) Nutrient names and quantitative establishments. amounts by weight shall be presented 318.3 Designation of places of receipt of in two separate columns; products and other articles for reinspec- (iii) The heading ‘‘Percent Daily tion. Value’’ required in § 317.309(d)(6) shall 318.4 Preparation of products to be offi- be placed immediately below the quan- cially supervised; responsibilities of offi- titative information by weight for pro- cial establishments; plant operated quality control. tein; 318.5 Requirements concerning procedures. (iv) The percent of the Daily Value 318.6 Requirements concerning ingredients for protein, vitamins, and minerals and other articles used in preparation of shall be listed immediately below the products. heading ‘‘Percent Daily Value’’; and 318.7 Approval of substances for use in the (v) Such labeling shall not include preparation of products. the footnote specified in § 317.309(d)(9). 318.8 Preservatives and other substances (d)(1) Products in packages that have permitted in product for export only; a total surface area available to bear handling; such product not to be used for labeling of less than 12 square inches domestic food purposes. 318.9 Samples of products, water, dyes, are exempt from nutrition labeling, chemicals, etc., to be taken for examina- provided that the labeling for these tion. products bear no nutrition claims or 318.10 Prescribed treatment of pork and other nutrition information. The man- products containing pork to destroy ufacturer, packer, or distributor shall trichinae. provide, on the label of packages that 318.11 [Reserved] qualify for and use this exemption, an 318.12 Manufacture of dog food or similar address or telephone number that a uninspected article at official establish- consumer can use to obtain the re- ments. quired nutrition information (e.g., 318.13 Mixtures containing product but not amendable to the Act. ‘‘For nutrition information call 1–800– 318.14 Adulteration of product by polluted 123–4567’’). water; procedure for handling. (2) When such products bear nutri- 318.15 Tagging chemicals, preservatives, ce- tion labeling, either voluntarily or be- reals, spices, etc., ‘‘U.S. retained.’’ cause nutrition claims or other nutri- 318.16 Pesticide chemicals and other resi- tion information is provided, all re- dues in products.

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318.17 Requirements for the production of lishment, may enter any official estab- cooked beef, roast beef, and cooked lishment subject in other respects to corned beef. the same restrictions as apply to do- 318.18 Handling of certain material for me- mestic product. Products received in chanical processing. 318.19 Compliance procedure for cured pork an official establishment during the products. Program employees absence shall be 318.20 Use of animal drugs. identified and maintained in a manner 318.21 Accreditation of chemistry labora- acceptable to such employee. Product tories. entering any official establishment 318.22 Determination of added water in shall not be used or prepared thereat cooked sausages. until it has been reinspected in accord- 318.23 Heat-processing procedures, cooking instructions, and cooling, handling, and ance with § 318.2. Any product origi- storage requirements for uncured meat nally prepared at any official establish- patties. ment may not be returned into any 318.24 Compliance procedures for meat depart of such establishment, except the rived from advanced meat/bone separa- receiving area approved under § 318.3, tion machinery and recovery systems. until it has been reinspected by the inspector. Subparts B—F [Reserved] (b) No slaughtered poultry or poultry Subpart G—Canning and Canned product shall be brought into an offi- Products cial establishment unless it has been (1) previously inspected and passed and 318.300 Definitions. is identified as such in accordance with 318.301 Containers and closures. the requirements of the Poultry Prod- 318.302 Thermal processing. 318.303 Critical factors and the application ucts Inspection Act (21 U.S.C. 451 et of the process schedule. seq.) and the regulations thereunder, 318.304 Operations in the thermal processing and has not been prepared other than area. in an establishment inspected under 318.305 Equipment and procedures for heat said Act, or (2) has been inspected and processing systems. passed and is identified as such in ac- 318.306 Processing and production records. cordance with the requirements of a 318.307 Record review and maintenance. 318.308 Deviations in processing. State law. 318.309 Finished product inspection. (c) Every article for use as an ingre- 318.310 Personnel and training. dient in the preparation of meat food 318.311 Recall procedure. products, when entering any official es- AUTHORITY: 7 U.S.C. 138f; 7 U.S.C. 450, 1901– tablishment and at all times while it is 1906; 21 U.S.C. 601–695; 7 CFR 2.17, 2.55. in such establishment, shall bear a label showing the name of the article, Subpart A—General the amount or percentage therein of any substances restricted by this part SOURCE: 35 FR 15586, Oct. 3, 1970, unless or part 317 of this subchapter, and a list otherwise noted. of ingredients in the article if composed of two or more ingredients: Pro- § 318.1 Products and other articles en- vided, That in the case of articles re- tering official establishments. ceived in tank car lots, only one such (a) Except as otherwise provided in label shall be used to identify each lot. paragraphs (g) and (h) of this section or In addition, the label must show the § 318.12, no product shall be brought name and address of the shipper. into an official establishment unless it (d) Containers of preparations which has been prepared only in an official es- enter any official establishment for use tablishment and previously inspected in hog scalding water or in denuding of and passed by a Program employee, tripe shall bear labels showing the and is identified by an official inspec- chemical names of the preparations. In tion legend as so inspected and passed. the case of any preparation containing Notwithstanding the foregoing provi- any of the chemicals which are specifi- sions of this subparagraph, product im- cally limited by § 318.7(c)(4) as to ported in accordance with part 327 of amount permitted to be used, the la- this subchapter and not prepared in the bels on the containers must also show United States outside an official estab- the percentage of each such chemical

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in the preparation and must provide di- subchapter may be received by official lution directions which prescribe the establishments for storage and dis- maximum allowable use concentration tribution solely in intrastate com- of the preparations. merce. The presence of such State in- (e) Dyes, chemicals, or other sub- spected products must not create any stances the use of which is restricted unsanitary condition or otherwise re- to certain products may be brought sult in adulteration of any products at into or kept in an official establish- the official establishment or interfere ment only if such products are pre- with the conduct of inspection under pared thereat. No prohibited dye, this subchapter. In addition, such chemical, preservative, or other sub- State inspected products must be stance shall be brought into or kept in stored separately and apart from the an official establishment. federally inspected products in the offi- (f) [Reserved] cial establishment. (g) Glands and organs, such as (i) The operator of the official estab- cotyledons, ovaries, prostate glands, lishment shall furnish such informa- tonsils, spinal cords, and detached lym- tion as is necessary to determine the phatic, pineal, pituitary, parathyroid, origin of any product or other article suprarenal, pancreatic and thyroid entering the official establishment. glands, used in preparing pharma- Such information shall include, but is ceutical, organotherapeutic, or tech- not limited to, the name and address of nical products and which are not used the seller or supplier, transportation as human food (whether or not pre- company, agent, or broker involved in pared at official establishments) may the sale or delivery of the product or be brought into and stored in edible article in question. product departments of inspected es- (j) Any product or any poultry or tablishments if packaged in suitable poultry product or other article that is containers so that the presence of such brought into an official establishment glands and organ will in no way inter- contrary to any provision of this sec- fere with the maintenance of sanitary tion may be required by the Adminis- conditions or constitute an inter- trator to be removed immediately from ference with inspection. Glands or or- such establishment by the operator gans which are regarded as human food thereof, and failure to comply with products, such as livers, testicles, and such requirement shall be deemed a thymus glands, may be brought into of- violation of this regulation. If any ficial establishments for pharma- slaughtered poultry or poultry prod- ceutical, organotherapeutic or tech- ucts or other articles are received at an nical purposes, only if U.S. inspected official establishment and are sus- and passed and so identified. Lungs and pected of being adulterated or mis- lung lobes derived from livestock branded under the Poultry Products In- slaughtered in any establishment may spection Act or the Federal Food, not be brought into any official estab- Drug, and Cosmetic Act, or applicable lishment except as provided in State laws, the appropriate govern- § 318.12(a). mental authorities will be notified. (h)(1) Carcasses of game animals, and [35 FR 15586, Oct. 3, 1970, as amended at 36 FR carcasses derived from the slaughter by 11639, June 17, 1971; 38 FR 5152, Feb. 26, 1973; any person of livestock of his own rais- 48 FR 6091, Feb. 10, 1983; 49 FR 32055, Aug. 10, ing in accordance with the exemption 1984] provisions of paragraph 23(a) of the Act, and parts of such carcasses, may § 318.2 Reinspection, retention, and be brought into an official establish- disposal of meat and poultry prod- ment for preparation, packaging, and ucts at official establishments. storing in accordance with the provi- (a) All products and all slaughtered sions of § 303.1(a)(2) of this subchapter. poultry and poultry products brought (2) Meat, meat byproducts, and meat into any official establishment shall be food products bearing official marks identified by the operator of the offi- showing that they were inspected and cial establishment at the time of re- passed under State inspection in any ceipt at the official establishment and State not designated in § 331.2 of this shall be subject to reinspection by a

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Program employee at the official es- soiled or unclean by falling on the floor tablishment in such manner and at or in any other accidental way or if the such times as may be deemed necessary product is affected with any other con- to assure compliance with the regula- dition which the inspector deems capa- tions in this subchapter. ble of correction, in which case the (b) All products, whether fresh, product shall be cleaned (including cured, or otherwise prepared, even trimming if necessary) or otherwise though previously inspected and handled in a manner approved by the passed, shall be reinspected by Pro- inspector to assure that it will not be gram employees as often as they may adulterated or misbranded and shall deem necessary in order to ascertain then be presented for reinspection and that they are not adulterated or mis- disposal in accordance with this sec- branded at the time they enter or leave official establishments and that the re- tion. If upon final inspection, the prod- quirements of the regulations in this uct is found to be neither adulterated subchapter are complied with. nor misbranded, the inspector shall re- (c) Reinspection may be accom- move the U.S. retained tag. If a prod- plished through use of statistically uct is found upon reinspection to be sound sampling plans that assure a misbranded, it shall be held under a high level of confidence. The circuit su- U.S. retained tag, or a U.S. detention pervisor shall designate the type of tag as provided in part 329 of this sub- plan and the program employee shall chapter, pending correction of the mis- select the specific plan to be used in branding or issuance of an order under accordance with instructions issued by section 7 of the Act to withhold from the Administrator. 1 use the labeling or container of the (d) A U.S. retained tag shall be product, or the institution of a judicial placed by a Program employee at the seizure action under section 403 of Act time of reinspection at any official es- or other appropriate action. The in- tablishment on all products which are spector shall make a complete record suspected on such reinspection of being of each transaction under this para- adulterated or misbranded, and such graph and shall report his action to the products shall be held for further in- area supervisor. spection. Such tags shall be removed only by authorized Program employ- [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, ees. When further inspection is made, if 1971] the product is found to be adulterated, all official inspection legends or other § 318.3 Designation of places of receipt official marks for which the product is of products and other articles for found to be ineligible under the regula- reinspection. tions in this subchapter, shall be re- Every official establishment shall moved or defaced and the product will designate, with the approval of the cir- be subject to condemnation and dis- cuit supervisor, a dock or place at posal in accordance with part 314 of which products and other articles sub- this subchapter, except that a deter- ject to reinspection under § 318.2 shall mination regarding adulteration may be received, and such products and ar- be deferred if a product has become ticles shall be received only at such dock or place. 1 Further information concerning sampling plans which have been adopted for specific § 318.4 Preparation of products to be products may be obtained from the Circuit officially supervised; responsibil- Supervisors of Program circuits. These sam- ities of official establishments; pling plans are developed for individual prod- plant operated quality control. ucts by the Washington staff and will be distributed for field use as they are developed. (a) All processes used in curing, pick- The type of plan applicable depends on fac- ling, rendering, canning, or otherwise tors such as whether the product is in con- preparing any product in official estab- tainers, stage of preparation, and procedures lishments shall be supervised by Pro- followed by the establishment operator. The specific plan applicable depends on the kind gram employees unless such prepara- of product involved, such as liver, oxtails, tion is conducted as a custom oper- etc. ation exempted from inspection under

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§ 303.1(a)(2) of this subchapter in any of- adhere to the requirements of the sys- ficial establishment or consists of oper- tem as approved by the Department; ations that are exempted from inspec- that all the establishment’s data, anal- tion under § 303.1(d) of this subchapter yses, and information generated by its and are conducted in a retail store in quality control system will be main- an establishment subject to inspection tained to enable the Department to only because the State or Territory in monitor compliance and available to which the establishment is located is Department personnel; that plant qual- designated under paragraph 301(c) of ity control personnel will have author- the Act. No fixtures or appliances, such ity to halt production or shipping of as tables, trucks, trays, tanks, vats, product in cases where the submitted machines, implements, cans, or con- quality control system requires it; and tainers of any kind, shall be used un- that the owner or operator (or his/her less they are of such materials and con- designee) will be available for consulta- struction as will not contaminate or tion at any time Department personnel otherwise adulterate the product and consider it necessary. are clean and sanitary. All steps in the (2) In the case of an establishment preparation of edible products shall be having one or more full-time persons conducted carefully and with strict whose primary duties are related to the cleanliness in rooms or compartments quality control system, an organiza- separate from those used for inedible tional chart showing that such people products. ultimately report to an establishment (b) It shall be the responsibility of official whose quality control respon- the operator of every official establish- sibilities are independent of or not pre- ment to comply with the Act and the dominantly production responsibil- regulations in this subchapter. In order ities. In the case of an establishment to carry out this responsibility effec- which does not have full-time quality tively, the operator of the establish- control personnel, information indicat- ment shall institute appropriate meas- ing the nature of the duties and respon- ures to assure the maintenance of the sibilities of the person who will be re- establishment and the preparation, sponsible for the quality control sys- marking, labeling, packaging and other tem. handling of its products strictly in ac- (3) A list identifying those Parts and cordance with the sanitary and other sections of the Federal meat inspection requirements of this subchapter. The regulations which are applicable to the effectiveness of such measures will be operations of the establishment apply- subject to review by the Department. ing for approval of a quality control (c) Applying for Total Plant Quality system. This list shall also identify Control. Any owner or operator of an which part of the quality control sys- official establishment preparing meat tem will serve to maintain compliance food product who has a total plant with the applicable regulations. quality control system or plan for con- (4) Detailed information concerning trolling such product, after ante- the manner in which the system will mortem and post-mortem inspection, function. Such information should in- through all stages of preparation, may clude, but not necessarily be limited request the Administrator to evaluate to, questions of raw material control, it to determine whether or not that the critical check or control points, system is adequate to result in product the nature and frequency of tests to be being in compliance with the require- made, the nature of charts and other ments of the Act and therefore qualify records that will be used, the length of as a U.S. Department of Agriculture time such charts and records will be (USDA) Total Plant Quality Control maintained in the custody of the offi- Establishment. Such a request shall, as cial establishment, the nature of defi- a minimum, include: ciencies the quality control system is (1) A letter to the Administrator designed to identify and control, the from the establishment owner of opera- parameters or limits which will be tor stating the company’s basis and used, and the points at which correc- purpose for seeking an approved qual- tive action will occur and the nature of ity control system and willingness to such corrective action—ranging from

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least to most severe: Provided, That, total quality control system or partial subsequent to approval of the total quality control program will result in plant quality control system by the finished products controlled in this Administrator, the official establish- manner being in full compliance with ment may produce a new product for the requirements of the Act and regu- test marketing provided labeling for lations thereunder, the total quality the product has been approved by the control system or partial quality con- Administrator, the inspector in charge trol program will be approved and has determined that the procedures for plans will be made for implementation preparing the product will assure that under departmental supervision. all Federal requirements are met, and (2) In any situation where the system the production for test marketing does or program is found by the Adminis- not exceed 6 months. Such new product shall not be produced at that establish- trator to be unacceptable, formal noti- ment after the 6-month period unless fication shall be given to the applicant approval of the quality control system of the basis for the denial. The appli- for that product has been received from cant will be afforded an opportunity to the Administrator. modify the system or program in ac- (d) Applying for Partial Quality Con- cordance with the notification. The ap- trol. Any owner or operator of an offi- plicant shall also be afforded an oppor- cial establishment preparing meat food tunity to submit a written statement products who has a quality control pro- in response to this notification of de- gram for a product, operation, or a part nial and a right to request a hearing of an operation, may submit it to the with respect to the merits or validity Administrator and request a deter- of the denial. If the applicant requests mination as to whether or not that pro- a hearing and the Administrator, after gram is adequate to result in product review of the answer, determines the being in compliance with the require- initial determination to be correct, he ments of the Act. Such a request shall, shall file with the Hearing Clerk of the as a minimum, include: Department the notification, answer (1) A letter from the establishment and the request for hearing, which official responsible for quality control shall constitute the complaint and an- stating the objective of the program, swer in the proceeding, which shall and that all data and information gen- thereafter be conducted in accordance erated by the program will be main- with Rules of Practice which shall be tained to enable the Department to adopted for this proceeding. monitor compliance and available to Department personnel. (3) The establishment owner or oper- (2) Detailed information concerning ator shall be responsible for the effec- raw material control, the critical tive operation of the approved total check or control points, the nature and plant quality control system or partial frequency of tests to be made, the quality control program to assure com- charts and records that will be used, pliance with the requirements of the the length of time such charts and Act and regulations thereunder. The records will be maintained in the cus- Secretary shall continue to provide the tody of the official establishment, the Federal inspection necessary to carry limits which will be used and the out his responsibilities under the Act. points at which corrective action will (f) Labeling Logo. Owners and opera- occur, and the nature of the corrective tors of official establishments having a action—ranging from the least to the total plant quality control system ap- most severe. proved under the provisions of para- (e) Evaluation and Approval of Total graph (c) of this section, may only use, Plant Quality Control or Partial Quality as a part of any labeling, the following Control. (1) The Administrator shall logo. Any labeling bearing the logo and evaluate the material presented in ac- any wording of explanation with re- cordance with the provisions of para- spect to this logo shall be approved as graph (c) or (d) of this section. If it is required by parts 316 and 317 of this determined by the Administrator on the basis of the evaluation, that the subchapter.

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ministrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be provided to the establishment owner or operator to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total plant quality control system or partial quality control program has been terminated in accordance with the provisions of this section, an application and request for approval of the same or a modified total plant quality control system will not be evaluated by the Administrator for at least 6 months from the termi- (g) Termination of Total Plant Quality nation date, or for at least 2 months Control or Partial Quality Control. (1) from the termination date in the case The approval of a total plant quality control system or a partial quality of a partial quality control program. control program may be terminated at (h)(1) Operating Schedule Under Total any time by the owner or operator of Plant Quality Control. An official estab- the official establishment upon written lishment with an approved total plant notice to the Administrator. quality control system may request ap- (2) The approval of a total plant qual- proval for an operating schedule of up ity control system or partial quality to 12 consecutive hours per shift. Per- control program may be terminated mission will be granted provided that: upon the establishment’s receipt of a (i) The official establishment has sat- written notice from the Administrator isfactorily operated under a total plant under the following conditions: quality control system for at least 1 (i) If adulterated or misbranded meat year. food product is found by the Adminis- (ii) All products prepared and trator to have been prepared for or dis- packaged, or processed after the end of tributed in commerce by the subject 8 hours of inspection shall only be a establishment. In such case, oppor- continuation of the processing mon- tunity will be provided to the estab- itored by the inspector and being con- lishment owner or operator to present ducted during the last hour of inspec- views to the Administrator within 30 tion. days of the date of terminating the ap- (iii) All immediate containers of proval. In those instances where there products prepared and packaged shall is conflict of facts, a hearing, under ap- bear code marks that are unique to any plicable Rules of Practice, will be pro- period of production beyond the 8 hours vided to the establishment owner or of inspection. The form of such code operator to resolve the conflict. The marks will remain constant from day Administrator’s termination of ap- to day, and a facsimile of the code proval shall remain in effect pending marks and their meaning shall be pro- the final determination of the proceed- vided to the inspector. ing. (2) Application. Applications shall be (ii) If the establishment fails to com- submitted to the Regional Director and ply with the quality control system or shall specify how the conditions in program to which it has agreed after § 318.4(h)(1) have been or will be met. being notified by letter from the Ad- (3) Monitoring by Inspectors. In order ministrator or his designee. Prior to to verify that an establishment is pre- such termination, opportunity will be paring and shipping product in accord- provided to the establishment owner or ance with the approved total plant operator to present views to the Ad- quality control system and the Act and

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regulations after the 8 hours of inspec- products shall be thoroughly cleaned tion, the official establishment may be on all surfaces and parts immediately provided overtime inspection services after being emptied of their contents, at the discretion of the circuit super- which shall follow promptly their re- visor and charged for such services. moval from the carcasses. (g) Clotted blood shall be removed (Reporting requirements were approved by the Office of Management and Budget under from hog hearts before they are control number 0583–0015) shipped from the official establishment or used in the preparation of meat food [35 FR 15586, Oct. 3, 1970, as amended at 36 FR 12003, June 24, 1971; 45 FR 54322, Aug. 15, 1980; products. 51 FR 32304, Sept. 11, 1986] (h) Beef rounds, beef bungs, beef middles, beef bladders, calf rounds, hog § 318.5 Requirements concerning pro- bungs, hog middles, and hog stomachs cedures. which are to be used as containers of (a)(1) Care shall be taken to assure any meat food product shall be pre- that product is not adulterated when sented for inspection, turned with the placed in freezers. If there is doubt as fat surface exposed. to the soundness of any frozen product, (i) Portions of casings which show in- the inspector will require the defrost- fection with Oesophagostomum or ing and reinspection of a sufficient other nodule-producing parasite, and quantity thereof to determine its ac- weasands infected with the larvae of tual condition. Hypoderma lineatum, shall be rejected, (2) Frozen product may be defrosted except that when the infestation is in water or pickle in a manner and slight and the nodules and larvae are with the use of facilities which are ac- removed, the casing or weasand may be ceptable to the inspector. Before such passed. product is defrosted, a careful exam- [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, ination shall be made to determine its 1971] condition. If necessary, this examination shall include defrosting of rep- § 318.6 Requirements concerning in- resentative samples by means other gredients and other articles used in than in water or pickle. preparation of products. (b) Product, such as pork tenderloins, (a) All ingredients and other articles brains, sweetbreads, stew, or chop used in the preparation of any product suey, shall not be packed in hermeti- shall be clean, sound, healthful, whole- cally sealed metal or glass containers, some, and otherwise such as will not unless subsequently heat processed or result in the product being adulterated. otherwise treated to preserve the prod- Official establishments shall furnish uct in a manner approved by the Ad- inspectors accurate information on all ministrator in specific cases. procedures involved in product prepa- (c) Care shall be taken to remove ration including product composition bones and parts of bones from product and any changes in such procedures es- which is intended for chopping. sential for inspectional control of the (d) Heads for use in the preparation product. of meat food products shall be split and (b)(1) The only animal casings that the bodies of the teeth, the turbinated may be used as containers of product and ethmoid bones, ear tubes, and horn are those from cattle, sheep, swine, or butts removed, and the heads then goats. thoroughly cleaned. (2) Casings for products shall be care- (e) Kidneys for use in the preparation fully inspected by Program employees. of meat food products shall first be Only those casings which have been freely sectioned and then thoroughly carefully washed and thoroughly soaked and washed. All detached kid- flushed with clean water immediately neys, including beef kidneys with de- before stuffing and are suitable for con- tached kidney fat, shall be inspected tainers, are clean, and are passed on before being used in or shipped from such inspection shall be used, except the official establishment. that preflushed animal casings packed (f) Cattle paunches and hog stomachs in salt or salt and glycerine solution or for use in the preparation of meat food other approved medium may be used

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without additional flushing provided CFR part 59 or 9 CFR part 362 or 381 they are found to be clean and other- and when found to be sound and otherwise acceptable and are thoroughly wise acceptable when presented for use. rinsed before use. Poultry products and egg products (3) Hog and sheep casings intended (other than shell eggs) which have not for use as containers of product may be been so inspected and passed for whole- treated by soaking in or applying someness shall not be used in the prep- thereto sound, fresh pineapple juice or aration of such meat food products. papain or bromelin or pancreatic ex- (10) Dry milk products which are in- tract to permit the enzymes contained tended for use as ingredients of meat in these substances to act on the cas- food products shall be considered ac- ings to make them less resistant. The ceptable for such use only when pro- casings shall be handled in a clean and duced in a plant approved by the De- sanitary manner throughout and the partment under the regulations in 7 treatment shall be followed by washing CFR part 58, and when found to be and flushing the casings with water sound and otherwise acceptable when sufficiently to effectively remove the presented for use. Dry milk products substance used and terminate the enzy- prepared in a plant not so approved matic action. shall not be used in the preparation of (4) On account of the invariable pres- such meat food products. ence of bone splinters, detached spinal (11) [Reserved] cords shall not be used in the prepara- (12) Ingredients for use in any prod- tion of edible product other than for uct may not bear or contain any pes- rendering where they constitute a suit- ticide chemical or other residues in ex- able raw material. cess of level permitted in § 318.16. (5) Testicles if handled as an edible product may be shipped from the offi- (13) Use of ‘‘Mechanically Separated cial establishment as such, but they (Kind of Poultry),’’ as defined in shall not be used as an ingredient of a § 381.173 of this chapter, in the prepara- meat food product. tion of meat food products shall accord (6) Tonsils shall be removed and shall with § 381.174 and all other applicable not be used as ingredients of meat food provisions of this subchapter. products. [35 FR 15586, Oct. 3, 1970, as amended at 38 FR (7) Blood from livestock prepared in 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; accordance with § 310.20 of this sub- 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, chapter may be used as an ingredient 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, of a meat food product for which a 1985; 60 FR 55982, Nov. 3, 1995] standard is prescribed in part 319 of this subchapter, if permitted by such § 318.7 Approval of substances for use in the preparation of products. standard, and may be used in any meat food product for which no such stand- (a)(1) No substance may be used in ard is prescribed in part 319 of this sub- the preparation of any product unless chapter if it is a common and usual in- it is approved in paragraph (c)(4) of this gredient of such product. section or elsewhere in part 318 or in (8) Intestines shall not be used as in- part 319 of this subchapter, or by the gredients in any meat food product for Administrator in specific cases. which a standard is prescribed in part (2) Approval of new substances or 319 of this subchapter and shall not be new uses or new levels of use of ap- used in other products unless the prod- proved substances may be granted by ucts are labeled in accordance with the Administrator if: § 317.8(b)(3) of this subchapter. (i) The substance has been previously (9) Poultry products and egg products approved by the Food and Drug Admin- (other than shell eggs) which are in- istration (FDA) for use in meat or tended for use as ingredients of meat meat food products as a food additive, food products shall be considered ac- color additive, or as a substance gen- ceptable for such use only when identi- erally recognized as safe and is listed fied as having been inspected and in title 21 of the Code of Federal Regu- passed for wholesomeness by the De- lations, parts 73, 74, 81, 172, 173, 179, 182 partment under the regulations in 7 or 184.

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(ii) Its use is in compliance with ap- might be present, additional samples plicable FDA requirements; and shall be collected and analyzed by gas (iii) The Administrator has deter- chromatography. Presumptive positive mined that: results must be confirmed by mass (A) The use of the substance will not spectrometry before being considered render the product in which it is used positive. If, during the interval re- adulterated or misbranded or otherwise quired for the Department to analyze not in compliance with the require- the confirmatory samples by gas ments of the Act; and chromotography and mass spectrom- (B) Its use is functional and suitable etry, changes are made in processing for the product and it is permitted for procedures which are expected to result use at the lowest level necessary to ac- in no confirmable levels of complish the stated technical effect as nitrosamines in pumped bacon pro- determined in specific cases. duced by these new procedures, an es- (3) Whenever the Administrator de- tablishment may submit samples to termines that approval of a new sub- USDA for analysis upon prior notifica- stance or new use or new level of use of tion and arrangements with USDA. If, an approved substance should be grant- however, an establishment furnishes ed in accordance with paragraph (a)(2) USDA with laboratory results from of this section, the Administrator shall testing five consecutive lots of pumped issue a final rule amending the chart of bacon produced under the new proce- substances in paragraph (c)(4) of this dures and the testing is performed by section to include the additional sub- the USDA methodology and proce- stance or new use of the substance, and dures, those results will be utilized in any technical effect or change in level making the determination concerning of use of the substance. the product produced under the new (4) No product shall bear or contain procedures. Should the results of these any substance which would render it tests reveal that confirmable levels of adulterated or misbranded, or which is nitorosamines are not indicated in any not approved in part 318 or part 319 of of the five consecutive lots, the con- this subchapter, or by the Adminis- firmation analysis by USDA shall be trator in specific cases. terminated and the establishment shall (b) Requirements for the use of ni- revert to normal monitoring status. In trite and sodium ascorbate or sodium the event the test results continue to erythorbate (isoascorbate) in bacon. indicate nitrosamines, however, USDA Nitrates shall not be used in curing shall proceed in its confirmation anal- bacon. ysis on the original samples taken for (1) Pumped bacon. With respect to confirmation. If any one of the original bacon injected with curing ingredients samples collected by USDA for con- and massaged bacon: sodium nitrite firmation if found to contain confirm- shall be used at 120 parts per million able levels of nitrosamines, all pumped (PPM) ingoing or an equivalent bacon in the producing establishment amount of potassium nitrite shall be and all future production will be reused (148 PPM ingoing); and 550 PPM of tained. The Department shall sample sodium ascorbate or sodium and analyze such retained pumped erythorbate (isoascorbate) shall be bacon for nitrosamines on a lot by lot used. Sodium ascorbate or sodium basis. A production lot shall be that erythorbate have a molecular weight of pumped bacon produced by the estab- approximately 198. Hydrated forms of lishment in any single shift. Samples these substances shall be adjusted to from any lot of pumped bacon under re- attain the equivalent of 550 PPM of so- tention found to contain nitrosamines dium ascorbate or sodium erythorbate. at a confirmable level shall cause the (2) The Department shall collect lot of pumped bacon to be disposed of samples of pumped bacon from produc- in a manner to assure it will not form ing plants and analyze them for the nitrosamines when cooked. Such dis- level of nitrosamines by the Thermal posal may include incorporation of the Energy Analyzer (TEA). In the event uncooked pumped bacon as an ingredi- that a TEA analysis indicates that a ent of another meat food product pro- confirmable level of nitrosamines vided it is processed for eating without

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further preparation in a manner to pre- plant has an approved partial quality clude the formation of nitrosamines. control program as provided in § 318.4 Bacon subsequently produced shall not (d), (e), and (g) such as to result in be retained because of nitrosamines if compliance with this provision. the operator of the establishment (4) The Department shall collect makes adjustments in the processing of samples of bacon from plants producing the product and laboratory results ob- under paragraph (b)(3) of this section tained by TEA analysis of samples and analyze them for the level of from five consecutive normal sized lots nitrosamines. Samples shall be ran- of pumped bacon indicates that the domly selected throughout the produc- product being produced contains no tion of a lot. The actual sampling plans confirmable levels of nitrosamines. and methods of analysis that are used These tests from five consecutive nor- will result in approximately the same mal sized lots of pumped bacon shall be likelihood as under paragraph (b)(2) of conducted by the Department: Pro- this section of having a presumptive vided, however, That if the establish- positive result when the true mean ment furnishes the Department with level of nitrosamines in a production the results of tests conducted under lot is 10 ppb. In the event of a presump- the methodology and procedures used tive positive result, the plant shall be- by the Department, such test results come subject to the provisions of para- will be utilized in making the deter- graph (b)(2) of this section. mination concerning the nitrosamine (5) Immersion cured bacon. Immersion content of the product. All tests of cured bacon may be placed in a brine pumped bacon for nitrosamines under solution containing salt, nitrite and this subparagraph shall be made on ° flavoring material or in a container pumped bacon cooked 340 F. for 3 min- with salt, nitrite and flavoring mate- utes on each side. In order to deter- rial. Sodium nitrite shall not exceed mine that no confirmable levels of 120 ppm ingoing or an equivalent nitrosamines are present in a sample amount of potassium nitrite (148 ppm tested, the testing must be performed ingoing) based on the actual or esti- by methodology and procedures that mated skin-free green weight of the would detect the presence of any bacon bellies. nitrosamines at 10 PPB. (3) Notwithstanding the provisions of (6) Bacon made with dry curing mate- paragraph (b)(1) of this section, sodium rials. With respect to bacon made with nitrite may be used at: dry curing materials, the product shall (i) 100 ppm ingoing (potassium nitrite be cured by applying a premeasured at 123 ppm ingoing); and 550 ppm so- amount of cure mixture to the bacon dium ascorbate or sodium erythorbate belly surfaces, completely covering the (isoascorbate) shall be used; provided surfaces. Sodium nitrite shall not ex- that the plant has an approved partial ceed 200 ppm ingoing or an equivalent quality control program as provided in amount of potassium nitrite (246 ppm § 318.4 (d), (e), and (g) such as to result ingoing) in dry cured bacon based on in compliance with this provision, or the actual or estimated skin-free green (ii) A predetermined level between 40 weight of the bacon belly. and 80 ppm (potassium nitrite at a (c) Under appropriate declaration as level between 49 and 99 ppm); 550 ppm required in parts 316 and 317 of this sub- sodium ascorbate or sodium chapter, the following substances may erythorbate (isoascorbate); and addi- be added to products: tional sucrose or other similar fer- (1) Common salt, approved sugars mentable carbohydrate at a minimum (sucrose, cane or beet sugar), maple of 0.7 percent and an inoculum of lactic sugar, dextrose, invert sugar, honey, acid producing bacteria such as corn syrup solids, (corn syrup, glucose Pediococcus acetolactii or other bacteria syrup and fructose), wood smoke, vin- demonstrated to be equally effective in egar, flavorings, spices, sodium nitrate, preventing the growth of botulinum sodium nitrite, potassium nitrate, po- toxin at a level sufficient for the pur- tassium nitrite, and other substances pose of preventing the growth of specified in the chart in paragraph botulinum toxin; provided that the (c)(4) of this section may be added to

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products under conditions, if any, spec- When any coloring matter or dye is ap- ified in this part or in part 317 of this plied to casings, there shall be no pene- subchapter. tration of coloring into the product. (2) Other harmless artificial (4) The substances specified in the flavorings may be added to products following chart are acceptable for use with the approval of the Administrator in the preparation of products, pro- in specific cases. vided they are used for the purposes in- (3) Coloring matter and dyes other dicated, within the limits of the than those specified in the chart in amounts stated and under other condi- paragraph (c)(4) of this section may be tions specified in this part and part 317 applied to products, mixed with ren- of this subchapter. In addition to the dered fat, applied to natural and artifi- substances listed in the following cial casings, and applied to such cas- chart, part 319 of this subchapter speci- ings enclosing products, if approved by fies other substances that are accept- the Administrator in specific cases. able in preparing specified products.

Class of substance Substance Purpose Products Amount

Acidifiers ...... Acetic acid ...... To adjust acidity ...... Various 2 ...... Sufficient for purpose.3 Citric acid ...... do ...... do ...... Do. Glucono delta-lactone ...... do ...... do ...... Do. Lactic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Tartaric acid ...... do ...... do ...... Do. Anti-coagulants ...... Citric acid ...... To prevent clotting .... Fresh blood of live- 0.2 percent with or without stock. water. When Water is used to make a solution of citric acid added to blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used. Sodium citrate ...... do...... do...... Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to blood of livestock, not more than 2 parts of water to 1 part of sodium citrate shall be used. Antifoaming agent .. Methyl polysilicone ...... To retard foaming ...... Soups ...... 10 parts per million. Rendered fats ...... Do. Curing pickle ...... 50 parts per million.

Antioxidants and BHA (butylated To retard rancidity ..... Dry sausage ...... 0.003 percent .006 percent oxygen intercep- hydroxyanisole). based on in com- tors. total weight. bination. BHT (butylated ...... do ...... do ...... do ...... hydroxytoluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.006 percent butylhydroquinone). in combination only with BHA and/or BHT. BHA (butylated ...... do ...... Rendered animal fat 0.01 percent 0.02 percent hydroxyanisole). or a combination of in com- such fat and vege- bination. table fat. BHT (butylated ...... do ...... do ...... do ...... hydroxytoluene). Glycine ...... do ...... do ...... do ...... Propyl gallate ...... do ...... do ...... do ...... Resin guaiac ...... do ...... do ...... do ......

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TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in combination only with BHA and/or BHT.

Tocopherols ...... do ...... do ...... 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as ``lard'' or ``rendered pork fat.'' ...... do ...... Dry sausage, semidry Not to exceed 0.03 percent sausage, dried based on fat content. Not meats, uncooked or used in combination with cooked fresh sau- other antioxidants. sage made with beef and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausage, pregrilled beef patties, and restructured meats.

BHA (butylated ...... do ...... Fresh pork, sausage, 0.01 percent 0.02 percent hydroxyanisole). brown and serve based on in com- sausages, fresh fat content. bination Italian sausage based on products, pregrilled fat content. beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. BHT (butylated ...... do ...... do ...... do ...... hydroxytoluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in combination only with BHA and/or BHT based on fat content. BHA (butylated ...... do ...... Dried meats ...... 0.01 percent 0.01 percent hydroxyanisole). based on in com- total weight. bination. BHT (butylated ...... do ...... do ...... do ...... hydroxytoluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.01 percent butylhydroquinone). in combination only with BHA and/or BHT.

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BHA (butylated ...... do ...... Margarine or oleo- 0.02 percent (by wt. of the hydroxyanisole). margarine. finished product) individually or in combination with other antioxidants approved for use in margarine. BHT (butylated ...... do ...... do ...... Do. hydroxytol-) uene). Octyl gallate ...... do ...... do ...... Do. Propyl gallate ...... do ...... do ...... Do. Dodecyl gallate ...... do ...... do ...... Do. Ascorbyl palmitate ...... do ...... do ...... Do. Ascorbyl stearate ...... do ...... do ...... Do. TBHQ (tertiary ...... do ...... do ...... 0.02 percent alone or in com- butylhydroqui- bination only with BHA and/ none). or BHT based on fat or oil content.

Class of substance Substance Purpose Products Amount

Binders and ex- Agar-agar ...... To stabilize and thick- Thermally processed 0.25 percent of finished prod- tenders. en. canned jellied meat uct. food products Algin ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. A mixture of sodium al- To bind meat pieces Restructured meat Sodium alginate not to ex- ginate, calcium car- food products. ceed 1.0 percent; calcium bonate and calcium carbonate not to exceed lactate/lactic acid (or 0.2 percent; and lactic acid/ glucono delta-lactone) calcium lactate (or glucono delta-lactone) not to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Ingredients of mixture must be added dry. Bread ...... To bind and extend Bockwurst ...... 3.5 percent individually or col- product. lectively with other binders. Calcium reduced dried ...... do ...... Sausages as provided Do. skim milk. in part 319...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders. spaghetti with meat and sauce and similar products Carrageenan ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. Carboxymethyl cellulose ...... do ...... Baked pies ...... Do. (cellulose gum) Cereal ...... To bind and extend Sausages as provided 3.5 percent individually or col- product. in part 319, lectively with other binders. bockwurst ...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans Dried milk ...... do ...... Sausage as provided 3.5 percent individually or col- in part 319. lectively with other binders...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans Enzyme (rennet) treated To bind and extend Sausages as provided 3.5 percent total finished calcium reduced dried product. in part 319. product. (Calcium lactate skim milk and calcium required at rate of 10 per- lactate cent of binder). 246

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Class of substance Substance Purpose Products Amount

...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5 (Calcium lactate required at rate of 10 percent of binder). Enzyme (rennet) treated ...... do ...... Imitation sausages, Sufficient for purpose in ac- sodium caseinate and nonspecific loaves, cordance with 21 CFR calcium lactate soups, stews 172.5. (Calcium lactate required at rate of 25 percent of binder). Gums, vegetable ...... do ...... Egg roll ...... Sufficient for purpose in accordance with 21 CFR 172.5. Methyl cellulose ...... To extend and to sta- Meat and vegetable 0.15 percent. bilize product (also patties. carrier) Isolated soy protein ...... To bind and extend Sausage as provided 2 percent. product. in Part 319, bockwurst ...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans ...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Sodium caseinate ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 182.1748 and 21 CFR 172.5...... do ...... do ...... Sausage as provided 2 percent in accordance with in Part 319.. 21 CFR 182.1748...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders in accordance with 21 CFR 182.1748...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders in accord- and sauce and ance with 21 CFR similar products 182.1748. Dry or dried whey ...... To bind or thicken ..... Sausage as provided 3.5 percent individually or col- in Part 319, lectively with other binders bockwurst and extenders. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans, pork or beef and extenders. with barbecue sauce Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c...... do ...... To bind meat pieces Restructured meat 3.5 percent individually or col- food products, lectively with other binders whole muscle meat and extenders. In accord- cuts ance with 21 CFR 184.1979c.

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Class of substance Substance Purpose Products Amount

Soy flour ...... To bind and extend Sausage as provided 3.5 percent individually or col- product. in Part 319, lectively with other binders bockwurst and extenders. Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders. Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Soy protein concentrate ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Xanthan gum ...... To maintain uniform Meat sauces, gravies Sufficient for purpose in ac- viscosity; suspen- or sauces and cordance with 21 CFR sion of particulate meats, canned or 172.5. matter, emulsion frozen and/or refrig- stability; freeze- erated meat salads, thaw stability. canned or frozen meat stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes. Carrageenan ...... To prevent purging of Cured pork products Not to exceed 1.5 percent of brine solution. as provided in 9 product formulation; not CFR 319.104. permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, and 172.626. Food starch modified ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.892. Sodium caseinate ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 182.1748. Isolated soy protein ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products.

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Class of substance Substance Purpose Products Amount

Bleaching agent ..... Hydrogen peroxide ...... To remove color ...... Tripe (substance must be removed from product by rinsing with clear water). Catalysts (sub- Nickel ...... To accelerate chemi- Rendered animal fats Do. stances must be cal reaction. or a combination of eliminated during such fats and vege- process). table fats. Sodium amide ...... Rearrangement of ...... do ...... Do. fatty acid radicals. Sodium methoxide ...... do ...... do ...... Do. Coloring agents Alkanet, annatto, caro- To color casings or Sausage casings, ole- Sufficient for purpose (may (natural). tene cochineal, green rendered fats; omargarine, short- be mixed with approved ar- chlorophyl, saffron marking and brand- ening, marking or tificial dyes or harmless and tumeric. ing product. branding ink on inert material such as com- product. mon salt and sugar). Coloring agents (ar- Color additives listed in ...... do ...... do ...... Sufficient for purpose (may tificial). 21 CFR Part 74, Sub- be mixed with approved part A of Part 82, natural coloring matters or Subpart B (operator harmless inert material must furnish evidence such as common salt or to inspector in charge sugar). that color additive has been certified for use in connection with foods by the Food and Drug Administra- tion). Titanium dioxide ...... do ...... Canned ham salad 0.5 percent. spread and creamed type canned products. Curing accelerators' Ascorbic acid ...... To accelerate color Cured pork and beef 75 oz to 100 gal pickle at 10 must be used fixing or preserve cuts, cured percent pump level; 3¤4 oz only in combina- color during storage. comminuted meat to 100 lb meat or meat by- tion with curing food product. product; 10 percent solu- agents. tion to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.) Erythorbic acid ...... do ...... do ...... Do. Fumaric acid ...... To accelerate color Cured, comminuted 0.065 percent (or 1 oz to 100 fixing. meat or meat food lb) of the weight of the products. meat or meat byproducts, before processing. Glucone delta lactone ... To accelerate color Cured, comminuted 8 oz to each 100 lb of meat fixing. meat or meat food or meat byproduct. product. Genoa salami ...... 16 oz to 100 lb of meat (1.0 percent). Sodium acid ...... do ...... Frankfurters, wieners, Not to exceed, alone or in pyrophosphate. vienna, bologna, combination with other cur- garlic bologna, ing accelerators, the follow- knockwurst, and ing: 8 oz in 100 lb of the similar products. meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product. Sodium ascorbate ...... To accelerate color Cured pork and beef 87.5 oz to 100 gal pickle at fixing or preserve cuts, cured 10 percent pump level; 7¤8 color during storage. comminuted meat oz to 100 lb meat or meat food product. byproduct; 10 percent solution to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.) Sodium erythorbate ...... do ...... do ...... Do.

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Class of substance Substance Purpose Products Amount

Citric acid or sodium cit- ...... do ...... do ...... May be used in cured prod- rate. ucts or in 10 percent solution used to spray surfaces of cured cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. Curing agents ...... Sodium or potassium ni- Source of nitrite ...... Cured products other 7 lb to 100 gal pickle; 31¤2 oz trate. than bacon. Ni- to 100 lb meat (dry cure); trates may not be 23¤4 oz to 100 lb chopped used in baby, jun- meat. ior, and toddler foods. Sodium or potassium ni- To fix color ...... Cured products. 2 lb to 100 gal pickle at 10 trite. (Supplies of so- Nitrites may not be percent pump level; 1 oz to dium nitrite and po- used in baby, jun- 100 lb meat (dry cure); 1¤4 tassium nitrite and ior, or toddler foods. oz to 100 lb chopped meat mixtures containing and/or meat byproduct. The them must be kept use of nitrites, nitrates, or securely under the combination shall not result care of a responsible in more than 200 parts per employee of the es- million of nitrite, calculated tablishment. The spe- as sodium nitrite, in fin- cific nitrite content of ished product. Except that such supplies must nitrites may be used in be known and clearly bacon only in accordance marked accordingly). with paragraph (b) of this section. Denuding agents; Lime (calcium oxide, To denude mucous Tripe ...... Sufficient for purpose. may be used in calcium hydroxide) membranes. combination. Sodium carbonate...... do ...... do. Do. Must be removed Sodium Citrate ...... do ...... do ...... Do. from tripe by rins- Sodium gluconate ...... do ...... do ...... Do. ing with potable Sodium hydroxide ...... do ...... do ...... Do. water.. Sodium persulfate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Trisodium phosphate ...... do...... do. Do. Emulsifying agents Acetylated To emulsify product ... Shortening ...... Do. monoglycerides. Diacetyl tartaric acid ...... do ...... Rendered animal fat Do. esters of mono- and or a combination of diglycerides. such fat with vegetable fat. Glycerol-lacto stearate, ...... do ...... do ...... Do. oleate, or palmitate. Lecithin ...... To emulsify product Oleomargarine, short- 0.5 percent in oleomargarine; (also as an Anti- ening, various meat use in other productsÐsuf- oxidant). food products. ficient amount for emulsi- fication. Mono and diglycerides To emulsify product ... Rendered animal fat Sufficient for purpose in lard (glycerol palmitate, or a combination of and shortening; 0.5 percent etc.). such fat with vege- in oleomargarine. table fat; oleomargarine. Mono and diglycerides ...... do ...... Margarine or oleo- 0.5 percent. of fatty acids margarine. esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate derivatives of these mono and diglycerides.

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Class of substance Substance Purpose Products Amount

Polygylcerol esters of ...... do ...... Rendered animal fat Sufficient for purpose for ren- fatty acids or a combination of dered animal fat or com- (polygylcerol esters of such fat with vege- bination with vegetable fat; fatty acids are re- table fat when use 0.5 percent for oleo- stricted to those up to is not precluded by margarine. and including the standards of iden- decaglycerol esters tity or composition; and otherwise meet- oleomargaine. ing the requirements of § 172.854(a) of the Food Additive Regula- tions). 1,2-propylene glycol ...... do ...... Margarine or oleo- 2.0 percent. esters of fatty acids. margarine. Polysorbate 80 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 60 sorbitan monooleate). baked goods, bak- the combined total shall not ing mixes, icings, exceed 1 percent. fillings, and toppings and in the frying of foods. Propylene glycol mono ...... do ...... Rendered animal fat Sufficient for purpose. and diesters of fats or a combination of and fatty acids. such fat with vegetable fat. Polysorbate 60 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 80 sorbitan monostea- baked goods, bak- the combined total shall not rate). ing mixes, icings, exceed 1 percent. fillings, and toppings and in the frying of foods. Stearyl-2-lactylic acid ...... do ...... Shortening to be used 3.0 percent. for cake icings and fillings. Stearyl monoglyceridyl ...... do ...... Shortening ...... Sufficient for purpose. citrate. Film forming agents A mixture consisting of To reduce cooler Freshly dressed meat Formulation may not exceed water, sodium algi- shrinkage and help carcasses. Such 1.5% of hot carcass weight nate, calcium chlo- protect surface. carcasses must when applied. Chilled ride, sodium bear a statement weight may not exceed hot carboxymethyl-cel- ``Protected with a weight. lulose, and corn syrup film of water, corn solids. syrup solids, sodium alginate, calcium chloride and sodium carboxymethyl-cellulose. Flavoring agents; Artificial smoke flavoring To flavor product ...... Various 2 ...... Do. protectors and developers. Smoke flavoring ...... do ...... do ...... Do. Autolyzed yeast extract ...... do ...... do ...... Do. Harmless bacteria start- To develop flavor ...... Dry sausage, pork 0.5 percent. ers of the acidophilus roll, thuringer, leb- type, lactic acid start- anon bologna, er or culture of cervelat, and salami. Pediococcus cerevisiae. Harmless lactic acid To prevent growth of Bacon ...... Sufficient for purpose. producing bacteria. Clostridium botulinum. Benzoic acid (sodium, To retard flavor rever- Margarine or oleo- 0.1 percent individually, or if potassium and cal- sion. margarine. used in combination or with cium salts). sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).

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Class of substance Substance Purpose Products Amount

Calcium lactate ...... To protect flavor ...... Cooked semi-dry and 0.6 percent in product formu- dry products includ- lation. ing sausage, imitation sausage, and non-specific meat food sticks. Citric acid ...... Flavoring ...... Chili con carne ...... Sufficient for purpose. Corn syrup solids, corn To flavor ...... Sausage, hamburger, Sufficient for purpose. syrup, glucose syrup. meat loaf, luncheon meat, chopped or pressed ham. Dextrose ...... To flavor product ...... Sausage, ham and Sufficient for purpose. cured products. Diacetyl ...... do ...... Oleomargarine ...... Do. Disodium guanylate ...... do ...... Various 2 ...... Do. Disodium inosinate ...... do ...... do ...... Do. Hydrolyzed plant protein ...... do ...... do ...... Do. Isopropyl citrate ...... To protect flavor ...... Oleomargarine ...... 0.02 percent. Malt syrup ...... To flavor product ...... Cured products ...... 2.5 percent. Milk protein hydrolysate ...... do ...... Various 2 ...... Sufficient for purpose. Monosodium glutamate ...... do ...... do ...... Do. Monoammonium glu- ...... do ...... do ...... Do. tamate. Sodium sulfoacetate de- ...... do ...... do ...... 0.5 percent. rivative of mono and diglycerides. Sodium tripoly-phos- To help protect flavor ``Fresh Beef,'' 2 ``Beef 0.5 percent of total product. phate. for Further Cook- ing,'' ``Cooked Beef,'' Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing. Mixtures of sodium ...... do ...... do ...... Do. tripolyphosphate and sodium metaphosphate, insoluble; and sodium polyphosphates, glassy. Sorbitol ...... To flavor, to facilitate Cooked sausage la- Not to exceed 2 percent of the removal of cas- beled frankfurter, the weight of the formula, ings from product, frank, furter, wiener, excluding the formula and to reduce and knockwurst; weight of water or ice, carmelization and cured pork and when used in accordance charring. pork products, as with 21 CFR 184.1835. provided in part 319 of this subchapter. Starter distillate ...... To help protect flavor Oleomargarine ...... Sufficient for purpose. Stearyl citrate ...... To protect flavor ...... do ...... 0.15 percent. Sugars (sucrose and To flavor product ...... Various 2 ...... Sufficient for purpose. dextrose). Potassium lactate ...... To flavor product ...... Various meat and Not to exceed 2 percent of meat food products, formulation; in accordance except infant for- with 21 CFR 184.1639. mula and infant food.2 Sodium lactate ...... do ...... do ...... Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1768. Gases ...... Carbon dioxide solid To cool product ...... Chopping of meat, Do. (dry ice). packaging of product. Nitrogen ...... To exclude oxygen .... Sealed container ...... Do.

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Class of substance Substance Purpose Products Amount

Hog scald agents; Caustic soda ...... To remove hair ...... Hog carcasses ...... Do. must be removed Dimethylpolysiloxane ...... do ...... do ...... Do. by subsequent Dioctyl sodium ...... do ...... do ...... Do. cleaning oper- sulfosuccinate. ations. Disodium-calcium ethyl- ...... do...... do. Do. enediamine- tetraacetate. Disodium phosphate ...... do ...... do ...... Do. Ethylenediamine- ...... do ...... do ...... Do. tetraacetic acid (sodium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide). Potassium hydroxide ...... do ...... do ...... Do. Propylene glycol ...... do ...... do ...... Do. Soap (prepared by the ...... do ...... do ...... Do. reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils). Sodium acid ...... do ...... do ...... Do. pyrophosphate. Sodium carbonate ...... do ...... do ...... Do. Sodium dodecylbenzene ...... do ...... do ...... Do. sulfonate. Sodium gluconate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. hexametaphosphate. Sodium lauryl sulfate ...... do ...... do ...... Do. Sodium mono and ...... do ...... do ...... Do. dimethylnaphthalene sulfonate (molecular weight 245±260). Sodium n-alkylbenzene ...... do ...... do ...... Do. sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16). Sodium pyrophosphate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sucrose ...... do ...... do ...... Do. Triethanolamine ...... do ...... do ...... Do. dodecylbenzene sulfonate. Trisodium phosphate ...... do ...... do ...... Do. Miscellaneous ...... Ascorbic acid, erythorbic To delay discoloration Fresh beef cuts, fresh Not to exceed, singly or in acid, citric acid, so- lamb cuts, and combination, 500 ppm or dium ascorbate and fresh pork cuts. 1.8 mg/sq inch of product sodium citrate, singly surface of ascorbic acid (in or in combination, accordance with 21 CFR under an approved 182.3013), erythorbic acid partial quality control (in accordance with 21 (PQC) program (9 CFR 182.3041), or sodium CFR 318.4 (d) & (e)). ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or sodium citrate (in accordance with 21 CFR 182.6751). d- and dl- To inhibit nitrosamine Pump-cured bacon .... 500 ppm; by injection or sur- alphatocopherol. formation. face application.

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Class of substance Substance Purpose Products Amount

Potassium sorbate ...... To retard mold growth Dry sausage ...... 10 percent in water solution may be applied to casings after stuffing or casings may be dipped in a 10 percent water solution prior to stuffing. Silicon dioxide ...... Processing aid/dis- Tocopherol-containing At level not to exceed 4.0 persant. bacon curing pre- percent in the dry mix. mixes. Sorbic acid (sodium, po- To preserve product Margarine or oleo- 0.1 percent individually, or if tassium, and calcium and to retard mold margarine. used in combination or with salts). growth. benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). Calcium disodium, To preserve product ...... do ...... 75 parts per million by weight EDTA (calcium and to protect flavor. of the finished oleo- disodium ethylene- margarine or margarine. diaminetetraacetate). Propyl paraben (propyl To retard mold growth Dry sausage ...... 3.5 percent in water solution p-hydroxybenzoate). may be applied to casings after stuffing, or casings may be dipped in solution prior to stuffing. Sodium bicarbonate ...... To neutralize excess Rendered fats, soups, Sufficient for purpose. acidity, cleaning curing pickle. vegetables. Calcium propionate ...... To retard mold growth Pizza crust ...... 0.32 percent alone or in combination based on weight of the flour brace used. Sodium propionate ...... do ...... do ...... Do. Sodium hydroxide ...... To decrease the Meat food products May be used only in com- amount of cooked containing phos- bination with phosphates in out juices. phates. a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product. Disodium phosphate ...... do ...... Meat food products 5 percent of phosphate in except where other- pickle at 10 percent pump wise prohibited by level; 0.5 percent of phos- the Federal meat phate in product (only clear inspection regula- solution may be injected tions. into product). Monosodium phosphate ...... do ...... do ...... Do. Sodium metaphosphate, ...... do ...... do ...... Do. insoluble. Sodium polyphosphate, ...... do ...... do ...... Do. glassy. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sodium pyrophosphate ...... do ...... do ...... Do. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Dipotassium phosphate ...... do ...... do ...... Do. Monopotassium phos- ...... do ...... do ...... Do. phate. Potassium ...... do ...... do ...... Do. tripolyphosphate. Potassium ...... do ...... do ...... Do. pyrophosphate. Citric acid (sodium and To acidify ...... Margarine or oleo- Sufficient for purpose. potassium salts). margarine. Lactic acid (sodium and ...... do ...... do ...... Do. potassium salts). L±Tartaric acid (sodium ...... do ...... do ...... Do. and sodium potassium salts). Adipic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Hydrochloric acid ...... do ...... do ...... Do. Sodium bicarbonate ...... To alkalize ...... do ...... Do.

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Class of substance Substance Purpose Products Amount

Sodium carbonate ...... do ...... do ...... Do. Sodium hydroxide ...... do ...... do ...... Do. Potassium carbonate ...... do ...... do ...... Do. Potassium bicarbonate ...... do ...... do ...... Do. Citric acid ...... To preserve cured Cured pork cuts ...... Not to exceed 30 percent in color during storage. water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 182.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to the product.) Sodium citrate buffered To inhibit the growth Cured and uncured, Not to exceed 1.3 percent of with citric acid to a pH of micro-organisms processed whole- the formulation weight of of 5.6. and retain product muscle meat food the product in accordance flavor during stor- products, e.g., ham. with 21 CFR 184.1751. age. Proteolytic enzymes Aspergillus oryzae ...... To soften tissues ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavusoryzae ...... do ...... do ...... Do. group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Refining agents Acetic acid ...... To separate fatty Rendered fats ...... Sufficient for purpose. (must be elimi- acids and glycerol. nated during process of manufacturing). Bicarbonate of soda ...... do ...... do ...... Do. Carbon (purified char- To aid in refining of ...... do ...... Do. coal). animal fats. Caustic soda (sodium To refine fats ...... do ...... Do. hydroxide). Diatomaceous earth; ...... do ...... do ...... Do. Fuller's earth. Sodium carbonate ...... do ...... do ...... Do. Tannic acid ...... do ...... do ...... Do. Rendering agents .. Tricalcium phosphate .... To aid rendering ...... Animal fats ...... Do. Trisodium phosphate ...... do ...... do ...... Do. Sources of radiation Ionizing radiation limited To control Trichinella Pork carcasses, or Minimum absorbed dose of to gamma rays from spiralis. fresh or previously 0.3 kiloGray (30 kilorads) to cobalt-60 or cesium- frozen cuts of pork a maximum absorbed dose 137. carcasses that have of 1 kiloGray (100 kilorads). not been cured or heat-processed. Artificial sweetners Saccharin ...... To sweeten product .. Bacon ...... 0.01 percent. Synergists (used in Citric acid ...... To increase effective- Any product permitted Not to exceed 0.01 percent combination with ness of antioxidants. to contain anti- based on fat content. antioxidants). oxidants as provided in this part. Malic acid ...... do ...... Lard and shortening .. 0.01 percent based on total weight in combination with antioxidants. Monoisopropyl citrate ...... do ...... Lard, shortening, ole- 0.02 percent. omargarine, fresh pork sausage, dried meats. Phosphoric acid ...... do ...... Lard and shortening .. 0.01 percent. Monoglyceride citrate ...... do ...... Lard, shortening, 0.02 percent. fresh pork sausage, dried meats.

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Class of substance Substance Purpose Products Amount

Tenderizing agents Aspergillus oryzae ...... To soften tissue ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavus ...... do ...... do ...... Do. oryzae group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Potassium chloride ...... do ...... do ...... Not more than 3 percent of a 2.0 molar solution. Magnesium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Calcium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Potassium, magnesium ...... do ...... do ...... A solution of approved inor- or calcium chloride. ganic chlorides injected into or applied to raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. 1 [Reserved] 2 Information as to the specific products for which use of this substance is approved may be obtained upon inquiry addressed to the Standards and Labeling Division, Meat and Poultry Inspection Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. 3 Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under § 317.4.

(d) No substance may be used in or on sodium benzoate may be used in or on any product if it conceals damage or any product only as provided in the inferiority or makes the product ap- chart in § 318.7(c)(4) or as approved by pear to be better or of greater value the Administrator in specific cases. than it is. Therefore: (Approved by the Office of Management and (1) Paprika or oleoresin paprika may Budget under control number 0583–008) not be used in or on fresh meat, such as steaks, or comminuted fresh meat food [35 FR 15586, Oct. 3, 1970] products, such as chopped and formed EDITORIAL NOTE: For FEDERAL REGISTER ci- steaks or patties; or in any other meat tations affecting § 318.7, see the List of CFR food products consisting of fresh meat Sections Affected in the Finding Aids sec- (with or without seasoning), except tion of this volume. chorizo sausage, and except other meat EFFECTIVE DATE NOTE: At 61 FR 58782, Nov. food products in which paprika or oleo- 19, 1996, § 318.7(c)(4) was amended by revising resin paprika is permitted as an ingre- in the chart of substances, under the Class of dient in a standard of identity or com- Substances, ‘‘Flavoring agents; protectors position in part 319 of this subchapter. and developers’’, the entry for the substance (2) Sorbic acid, calcium sorbate, so- ‘‘Corn syrup solids, corn syrup, glucose dium sorbate, and other salts of sorbic syrup’’, effective Jan. 21, 1997. For the con- acid may not be used in cooked sausage venience of the user, the superseded text is or any other product; sulfurous acid set forth as follows: and salts of sulfurous acid may not be § 318.7 Approval of substances for use in the used in or on any product and niacin or preparation of products. nicotinamide may not be used in or on fresh product; except that potassium * * * * * sorbate, propylparaben (propyl p- hydroxybenzoate), calcium propionate, (c) * * * sodium propionate, benzoic acid, and (4) * * *

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Class of substance Substance Purpose Products Amount

******* Corn syrup solids, corn To flavor ...... Sausage, hamburger, 2.0 percent individually or col- syrup, glucose syrup. meat loaf, luncheon lectively, calculated on a meat, chopped or dry basis. pressed ham. *******

§ 318.8 Preservatives and other sub- port under paragraph (a) of this section stances permitted in product for ex- shall not be removed, in whole or in port only; handling; such product part, from such container prior to ex- not to be used for domestic food portation, except under the supervision purposes. of a Program employee. If such con- (a) Preservatives and other sub- tents are removed prior to exportation, stances not permitted in domestic then the article shall be either re- product under the regulations in this packed, in accordance with the provi- subchapter may be used in the prepara- sions of paragraphs (b) and (c) of this tion and packing of product intended section, or destroyed for food purposes for export provided the product (1) ac- under the direct supervision of a Pro- cords to the specifications or direc- gram employee. tions of the foreign purchaser; (2) is not (f) Permission must be obtained from in conflict with the laws of the country to which it is intended for export; and the Administrator before meats packed (3) is labeled on the outside container in borax are shipped from one official to show that it is intended for export, establishment to another or to an unof- and is otherwise labeled as required by ficial establishment for storage, except this subchapter for such export prod- such meat prepared for the account of uct. Federal agencies. (b) The preparation and packing of (g) At all times, the identity of meat export product as provided for in para- to which borax has been added shall be graph (a) of this section shall be done effectively maintained. In no case shall in a manner acceptable to the inspec- such meat, nor any trimmings or fat tor in charge so that the identity of derived from such meat, whether un- the export product is maintained con- washed or washed, or otherwise treat- clusively and the preparation of domes- ed, be diverted to domestic use. tic product is adequately protected. (h) Salt used for bulking meat pre- The preservatives and other substances viously packed in borax may not again not permitted in domestic product be used in an edible products depart- shall be stored in a room or compartment other than in connection with ment separate from areas used to store the packing of meat in borax. Only other supplies and shall be held under metal equipment should be used for Program lock. Use of the preservatives handling such meat. Particularly effec- or other substances shall be under the tive cleansing will be required if wood- direct supervision of a Program em- en equipment such as trucks, washing ployee. vats, etc., is used. Boxes from which (c) The packing of all articles under paragraph (a) of this section shall be boraxed meat has been removed may be conducted under the direct supervision used for repacking meat in borax, but of a Program employee. their use as containers for other meat (d) No article prepared or packed for will be dependent upon the effective re- export under paragraph (a) of this sec- moval of all traces of borax. tion shall be sold or offered for sale for (i) The following instructions pertain domestic use or consumption, but un- to export cured pork packed in borax less exported shall be destroyed for for the account of Federal agencies. food purposes under the direct super- The meat may be packed in borax in a vision of a Program employee. room in which there is borax-free meat, (e) The contents of the container of provided proper care is taken to see any article prepared or packed for ex- that the borax-free meat is not affected

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by the borax. Under the same condi- establishment where such products are tion, meat packed in borax may be re- prepared: Bologna, frankfurter, vienna, ceived, unpacked, defrosted, soaked, and other cooked sausage; smoked sau- washed, smoked, and repacked in a sage; knoblauch sausage; mortadella; room where there is other meat. How- all forms of summer or dried sausage, ever, meat originally packed in borax including mettwurst; flavored pork shall at all times be subject to the re- sausages such as those containing wine strictions of meat so packed, even or similar flavoring materials; cured though repacked without borax. After pork sausage; sausage containing cured packing or repacking, borax packed and/or smoked pork; cooked loaves; meat may be stored in a room with roasted, baked, boiled, or cooked hams, meat not packed in borax, provided a pork shoulders, or pork shoulder pic- reasonable degree of separation is nics; Italian-style hams; Westphalia- maintained between the two classes of style hams; smoked boneless pork product. shoulder butts; cured meat rolls; [35 FR 15586, Oct. 3, 1970; 36 FR 11903, June 23, capocollo (capicola, capacola); coppa; 1971, as amended at 38 FR 29214, Oct. 23, 1973] fresh or cured boneless pork shoulder butts, hams, loins, shoulders, shoulder § 318.9 Samples of products, water, picnics, and similar pork cuts, in cas- dyes, chemicals, etc., to be taken for ings or other containers in which examination. ready-to-eat delicatessen articles are Samples of products, water, dyes, customarily enclosed (excepting chemicals, preservatives, spices, or Scotch-style hams); breaded pork prod- other articles in any official establish- ucts; cured boneless pork loins; ment shall be taken, without cost to boneless back bacon; bacon used for the Program, for examination, as often wrapping around patties, steaks and as may be deemed necessary for the ef- similar products; and smoked pork cuts ficient conduct of the inspection. such as hams, shoulders, loins, and pork shoulder picnics (excepting § 318.10 Prescribed treatment of pork and products containing pork to de- smoked hams, and smoked pork shoul- stroy trichinae. der picnics which are specially prepared for distribution in tropical cli- (a)(1) All forms of fresh pork, includ- mates or smoked hams delivered to the ing fresh unsmoked sausage containing pork muscle tissue, and pork such as Armed Services); ground meat mix- bacon and jowls, other than those cov- tures containing pork and beef, veal, ered by paragraph (b) of this section, lamb, mutton, or goat meat and other are classed as products that are cus- product consisting of mixtures of pork tomarily well cooked in the home or and other ingredients, which the Ad- elsewhere before being served to the ministrator determines at the time the consumer. Therefore, the treatment of labeling for the product is submitted such products for the destruction of for approval in accordance with part trichinae is not required. 317 of the regulations in this sub- (2) Pork from carcasses or carcass chapter or upon subsequent reevalua- parts that have been found free of tion of the product, would be prepared trichinae as described under paragraph in such a manner that the product (e) or (f) of this section is not required might be eaten rare or without thor- to be treated for the destruction of ough cooking because of the appear- trichinae. ance of the finished product or other- (b) Products named in this para- wise. Cured boneless pork loins shall be graph, and products of the character subjected to prescribed treatment for hereof, containing pork muscle tissue destruction of trichinae prior to being (not including pork hearts, pork stom- shipped from the establishment where achs, and pork livers), or the pork mus- cured. cle tissue which forms an ingredient of (c) The treatment shall consist of such products, shall be effectively heating, refrigerating, or curing, as fol- heated, refrigerated, or cured to de- lows: stroy any possible live trichinae, as (1) Heating. (i) All parts of the pork prescribed in this section at the official muscle tissue shall be heated according

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to one of the time and temperature TABLE 1ÐREQUIRED PERIOD OF FREEZING AT combinations in the following table: TEMPERATURE INDICATED

Minimum internal temperature Temperature °F. Group 1 (Days) Group 2 (Days)

De- Minimum 5 20 30 Degrees fahrenheit grees time ¥10 10 20 centi- ¥20 6 12 grade

120 ...... 49.0 21 hours. (i) Group 1 comprises product in sepa- 122 ...... 50.0 9.5 hours. rate pieces not exceeding 6 inches in 124 ...... 51.1 4.5 hours. 126 ...... 52.2 2 hours. thickness, or arranged on separate 128 ...... 53.4 1 hour. racks with the layers not exceeding 6 130 ...... 54.5 30 minutes. inches in depth, or stored in crates or 132 ...... 55.6 15 minutes. 134 ...... 56.7 6 minutes. boxes not exceeding 6 inches in depth, 136 ...... 57.8 3 minutes. or stored as solidly frozen blocks not 138 ...... 58.9 2 minutes. exceeding 6 inches in thickness. 140 ...... 60.0 1 minute. 142 ...... 61.1 1 minute. (ii) Group 2 comprises product in 144 ...... 62.2 Instant. pieces, layers, or within containers, the thickness of which exceeds 6 inches but (ii) Time and temperature shall be not 27 inches, and product in contain- monitored by a calibrated recording in- ers including tierces, barrels, kegs, and strument that meets the requirements cartons having a thickness not exceed- of paragraph (d) of this section, except ing 27 inches. for paragraph (c)(1)(iv). (iii) The product undergoing such re- (iii) The time to raise product tem- frigeration or the containers thereof perature from 60 °F. to 120 °F shall not shall be so spaced while in the freezer exceed 2 hours unless the product is as will insure a free circulation of air cured or fermented. between the pieces of meat, layers, (iv) Time, in combination with tem- blocks, boxes, barrels, and tierces in peratures of 138 °F to 143 °F, need not order that the temperature of the meat be monitored if the product’s minimum throughout will be promptly reduced to thickness exceeds 2 inches (5.1 cm) and not higher than 5 °F., ¥10 °F., or ¥20 refrigeration of the product does not °F., as the case may be. begin within 5 minutes of attaining 138 (iv) In lieu of the methods prescribed °F (58.9 °C). in Table 1, the treatment may consist (v) The establishment shall use proof commercial freeze drying or con- cedures which insure the proper heat- trolled freezing, at the center of the ing of all parts of the product. It is im- meat pieces, in accordance with the portant that each piece of sausage, times and temperatures specified in each ham, and other product treated by Table 2. heating in water be kept entirely sub- merged throughout the heating period; TABLE 2ÐALTERNATE PERIODS OF FREEZING AT and that the largest pieces in a lot, the TEMPERATURES INDICATED innermost links of bunched sausage or other massed articles, and pieces Maximum internal temperature placed in the coolest part of a heating Degrees Minimum Degrees Fahrenheit centi- Time cabinet or compartment or vat be in- grade cluded in the temperature tests. (2) Refrigerating. At any stage of prep- 0 ...... ¥17.8 106 hours. ¥5 ...... ¥20.6 82 hours. aration and after preparatory chilling ¥10 ...... ¥23.3 63 hours. to a temperature of not above 40 °F. or ¥15 ...... ¥26.1 48 hours. preparatory freezing, all parts of the ¥20 ...... ¥28.9 35 hours. ¥25 ...... ¥31.7 22 hours. muscle tissue of pork or product con- ¥30 ...... ¥34.5 8 hours. taining such tissue shall be subjected ¥35 ...... ¥37.2 1¤2 hour. continuously to a temperature not higher than one of those specified in (v) During the period of refrigeration table 1, the duration of such refrigera- the product shall be kept separate from tion at the specified temperature being other products and in the custody of dependent on the thickness of the meat the Program in rooms or compart- or inside dimensions of the container. ments equipped and made secure with

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an official Program lock or seal. The drying room in less than 25 days from the rooms or compartments containing time the curing materials are added, except product undergoing freezing shall be that sausage of the variety known as equipped with accurate thermometers pepperoni, if in casings not exceeding the size specified, may be released at the expira- placed at or above the highest level at tion of 20 days from the time the curing ma- which the product undergoing treat- terials are added. Sausage in casings exceed- ment is stored and away from refrig- ing 31⁄2 inches, but not exceeding 4 inches, in erating coils. After completion of the diameter at the time of stuffing, shall be prescribed freezing of pork to be used held in a drying room not less than 35 days in the preparation of product covered at a temperature not lower than 45 °F., and by paragraph (b) of this section the in no case shall the sausage be released from pork shall be kept under close super- the drying room in less than 40 days from the time the curing materials are added to the vision of an inspector until it is pre- meat. pared in finished form as one of the Method No. 2. The meat shall be ground or products enumerated in paragraph (b) chopped into pieces not exceeding three- of this section or until it is transferred fourths of an inch in diameter. A dry-curing under Program control to another offi- mixture containing not less than 31⁄3 pounds cial establishment for preparation in of salt to each hundredweight of the such finished form. unstuffed sausage shall be thoroughly mixed (vi) Pork which has been refrigerated with the ground or chopped meat. After being stuffed, sausage having a diameter not as specified in this subparagraph may exceeding 31⁄2 inches, measured at the time of be transferred in sealed railroad cars, stuffing, shall be smoked not less than 40 sealed motortrucks, sealed trailers, or hours at a temperature not lower than 80 °F., sealed closed containers to another of- and finally held in a drying room not less ficial establishment at the same or an- than 10 days at a temperature not lower than other location, for use in the prepara- 45 °F. In no case, however, shall the sausage tion of product covered by paragraph be released from the drying room in less than 18 days from the time the curing mate- (b) of this section. Such vehicles and rials are added to the meat. Sausage exceed- containers shall be sealed and trans- ing 31⁄2 inches, but not exceeding 4 inches, in ported between official establishments diameter at the time of stuffing, shall be in accordance with § 325.7 of this sub- held in a drying room, following smoking as chapter. above indicated, not less than 25 days at a (3) Curing—(i) Sausage. The sausage temperature not lower than 45 °F., but in no may be stuffed in animal casings, case shall the sausage be released from the hydrocellulose casings, or cloth bags. drying room in less than 33 days from the time the curing materials are added to the During any stage of treating the sau- meat. sage for the destruction of live Method No. 3. The meat shall be ground or trichinae, except as provided in Method chopped into pieces not exceeding three- 5, these coverings shall not be coated fourths of an inch in diameter. A dry-curing with paraffin or like substance, nor mixture containing not less than 31⁄3 pounds shall any sausage be washed during any of salt to each hundredweight of the prescribed period of drying. In the unstuffed sausage shall be thoroughly mixed preparation of sausage, one of the fol- with the ground or chopped meat. After admixture with the salt and other curing mate- lowing methods may be used: rials and before stuffing, the ground or Method No. 1. The meat shall be ground or chopped meat shall be held at a temperature chopped into pieces not exceeding three- not lower than 34 °F. for not less than 36 fourths of an inch in diameter. A dry-curing hours. After being stuffed, the sausage shall mixture containing not less than 31⁄3 pounds be held at a temperature not lower than 34 of salt to each hundredweight of the °F. for an additional period of time sufficient unstuffed sausage shall be thoroughly mixed to make a total of not less than 144 hours with the ground or chopped meat. After from the time the curing materials are added being stuffed, sausage having a diameter not to the meat, or the sausage shall be held for exceeding 31⁄2 inches, measured at the time of the time specified in a pickle-curing medium stuffing, shall be held in a drying room not of not less than 50° strength (salometer read- less than 20 days at a temperature not lower ing) at a temperature not lower than 44 °F. than 45 °F., except that in sausage of the va- Finally, sausage having a diameter not ex- riety known as pepperoni, if in casings not ceeding 31⁄2 inches, measured at the time of exceeding 13⁄8 inches in diameter measured at stuffing, shall be smoked for not less than 12 the time of stuffing, the period of drying hours. The temperature of the smokehouse may be reduced to 15 days. In no case, how- during this period at no time shall be lower ever, shall the sausage be released from the than 90 °F.; and for 4 consecutive hours of

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this period the smokehouse shall be main- other substance approved by the Adminis- tained at a temperature not lower than 128 trator. °F. Sausage exceeding 31⁄2 inches, but not ex- Method No. 6. (A) Basic requirements. The ceeding 4 inches, in diameter at the time of meat shall be ground or chopped into pieces stuffing shall be smoked, following the pre- not exceeding three-fourths of an inch in di- scribed curing, for not less than 15 hours. ameter. A dry-curing mixture containing not The temperature of the smokehouse during less than 3.33 pounds of salt to each hundred- the 15-hour period shall at no time be lower weight of the unstuffed sausage, excluding than 90 °F., and for 7 consecutive hours of the weight of dry ingredients, shall be thor- this period the smokehouse shall be main- oughly mixed with the ground or chopped tained at a temperature not lower than 128 meat. After the curing mixture has been °F. In regulating the temperature of the added, the sausage shall be held for two time smokehouse for the treatment of sausage periods, a holding period and a drying period. under this method, the temperature of 128 The holding period will be for a minimum of °F. shall be attained gradually during a pe- 48 hours at a room temperature not lower riod of not less than 4 hours. than 35 °F. This holding period requirement Method No. 4. The meat shall be ground or may be fulfilled totally or in part before the chopped into pieces not exceeding one-fourth drying period and then the remainder, if any, of an inch in diameter. A dry-curing mixture after the drying period or as an extension of the drying period. During the drying period, containing not less than 21⁄2 pounds of salt to each hundredweight of the unstuffed sausage the sausage shall be held in a drying room at ° shall be thoroughly mixed with the ground a temperature not lower than 50 (10.0 F. (10.0 ° or chopped meat. After admixture with the C) for a period of time determined by Tables salt and other curing materials and before 3A, 3B, and 4. The length of the drying pe- stuffing, the ground or chopped sausage shall riod, established in (c)(3)(i)(A), may be modi- be held as a compact mass, not more than 6 fied as provided in paragraphs (c)(3)(i)(B) and inches in depth, at a temperature not lower (c)(3)(i)(C) of this section. than 36 °F. for not less than 10 days. At the termination of the holding period, the sau- TABLE 3AÐSAUSAGE DRYING ROOM TIMES BY sage shall be stuffed in casings or cloth bags METHOD NO. 6 not exceeding 31⁄3 inches in diameter, meas- Days ured at the time of stuffing. After being 1 in dry- stuffed, the sausage shall be held in a drying Diameter of casing at time of stuffing ing 2 room at a temperature not lower than 45 °F. room for the remainder of a 35-day period, meas- Up to: ured from the time the curing materials are 1 inches ...... 14 added to the meat. At any time after stuff- 11¤2 inches ...... 15 ing, if the establishment operator deems it 2 inches ...... 16 desirable, the product may be heated in a 21¤2 inches ...... 18 water bath for a period not to exceed 3 hours 3 inches ...... 20 at a temperature not lower than 85 °F., or 31¤2 inches ...... 23 subjected to smoking at a temperature not 4 inches ...... 25 41¤2 inches ...... 30 lower than 80 °F., or the product may be both 5 inches ...... 35 heated and smoked as specified. The time 51¤2 inches ...... 43 consumed in heating and smoking, however, 6 inches ...... 50 shall be in addition to the 35-day holding pe- 1 The drying room times for flattened or oval sausages shall riod specified. use a diameter derived by measuring the circumference and Method No. 5. The meat shall be ground or dividing by 3.14 (pi). chopped into pieces not exceeding three- 2 Drying room time may be modified as set forth in Tables 3B and 4. fourths of an inch in diameter. A dry-curing mixture containing not less than 31⁄3 pounds (B) Reduction in Drying Room Time. During of salt to each hundredweight of the the holding period, the sausage may be unstuffed sausage shall be thoroughly mixed smoked or fermented. If the temperature is with the ground or chopped meat. After increased to 70 °F. (21.1 °C) or higher, while being stuffed, the sausage shall be held for the sausage is being held after adding curing not less than 65 days at a temperature not materials but before the drying period, the lower than 45 °F. The coverings for sausage subsequent drying room times prescribed for prepared according to this method may be this method may be reduced according to the coated at any stage of the preparation before schedule in Table 3B. No interpolation of val- or during the holding period with paraffin or ues is permissible.

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TABLE 3BÐPERCENTAGE REDUCTION IN DRYING ROOM TIME (TABLE 3A) PERMITTED BY HOLDING TIMES AND TEMPERATURES PRIOR TO DRYING 1

Minimum Temperature 2 Minimum Time 70 °F 75 °F 80 °F 85 °F 90 °F 95 °F 100 °F 105 °F 110 °F 120 °F 21.1 °C 23.9 °C 26.7 °C 29.5 °C 32.2 °C 35.0 °C 37.9 °C 40.6 °C 43.3 °C 48.9 °C

24 hours ...... 4 5 8 10 15 23 37 57 90 3 100 48 hours ...... 9 12 18 25 35 49 88 3 100 3 100 100 72 hours ...... 14 19 28 39 55 74 3 100 100 100 100 96 hours ...... 19 26 38 53 75 98 100 100 100 100 120 hours ...... 24 33 48 67 95 3 100 100 100 100 100 1 In computing the days to be deducted, the number with any fraction shall be rounded to the next lower whole number and shall be deducted from the required total drying time. Example: Sausage stuffed in 3″ diameter casing requires 20 days in the drying room (from Drying Room Times, Table 3A). If allowed to ferment, after addition of curing materials, at 80 °F. for 48 hours, the 20 day drying time may be reduced 18% (from Table 3B). Eighteen percent of 20 day equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the drying room, therefore, will be 17 days. 2 Either room temperature or internal product temperature shall be used for sausages that will be subsequently dried to a moisture-protein ratio of 2.3:1 or less. Internal product temperature shall be used for all other sausages. 3 Trichinae will be destroyed during fermentation or smoking at the temperature and length of time indicated. Therefore, no drying room period is required for products so treated.

(C) Reduced Salt Content—Drying Room 2 In computing the days to be added to the required total drying time, fractions shall be rounded to the next higher Times. Salt content of less than 3.33 pounds whole number and added to the required total drying time. Ex- for each hundredweight of sausage formula- ample: Sausage stuffed in 31¤2 inch diameter casing requires tion, excluding dry ingredients, (such as 23 days in the drying room (from Drying Room Times). If the quantity of salt added per hundredweight of sausage is 2 salts, sugars, and spices), may be permitted pounds instead of 3.33 pounds, the drying room time must be provided the drying time is increased accord- increased by 40 percent (from Reduced Salt Content-Drying Room Times), or 9.2 days. The 9.2 is rounded up to 10 days ing to the schedule contained in Table 4. and is added to the 23 days to equal 33 days. The total drying time required in the drying room, therefore, will be 33 TRICHINA TREATMENT OF SAUSAGE BY METHOD days. NO. 6; Method No. 7, Dry Sausages. (A) General Re- quirements. The establishment shall use meat TABLE 4ÐREDUCED SALT CONTENTÐDRYING particles reduced in size to no more than 1/ ROOM TIMES 4 inch in diameter. The establishment shall [Required percentage increase in drying room time (table 3A) add a curing mixture containing no less than for added salt of less than 3.33 pounds per hundredweight 2.7 pounds of salt per hundred pounds of meat of sausage] and mix it uniformly throughout the prod- Increase uct. The establishment shall hold, heat, and in drying dry the product according to paragraph (B) Minimum pounds of salt added to sausage 1 room or (C) below. time 2 (B) Holding, Heating, and Drying Treatment, 3.3 ...... 1 Large Sausages. Except as permitted in (C) 3.2 ...... 4 below, the establishment shall subject sau- 3.1 ...... 7 sages in casings not exceeding 105 mm in di- 3.0 ...... 10 ameter, at the time of stuffing, to all of the 2.9 ...... 13 following minimum chamber temperatures 2.8 ...... 16 and time periods. 2.7 ...... 19 2.6 ...... 22 TREATMENT SCHEDULE FOR SAUSAGES 105 MIL- 2.5 ...... 25 LIMETERS (41¤8 INCHES) OR LESS IN DIAMETER 2.4 ...... 28 2.3 ...... 31 Minimum chamber temperature Minimum time 2.2 ...... 34 (°F) (°C) (hours) 2.1 ...... 37 2.0 ...... 40 50 10 12 1 Calculate the salt content for column 1 as follows: Multiply 90 32.2 1 the pounds of salt in the sausage formulation by 100. Then di- 100 37.8 1 vide this number by the total weight of sausage formulation 110 43.3 1 minus the weight of dry ingredients and round down to the 120 48.9 1 next lowest 0.1%. Percents may be substituted for pounds. 125 51.7 7 Example: 120 lbs. pork, 3.56 lbs. salt, 2 lbs. spices, 0.5 lbs. wine, 1 lb. water and starter culture, 0.8 lbs. sugar, .012 lbs. sodium nitrite total weight is 127.872 lbs. Following the preceding treatment, the es- (3.56×100)/(127.872¥3.56¥2¥.8¥.012)=356/121.5=2.93 tablishment shall dry the sausages at a tem- Therefore, the sausage drying time must be increased by perature not lower than 50 °F (10 °C) for not 13 percent. less than 7 days.

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(C) Heating and Drying Treatment, Small to any treatment designed to remove Sausages. Alternatively, the establishment salt from the meat, except that super- may subject sausages in casings not exceed- ficial washing may be allowed. After ing 55 mm in diameter, at the time of stuff- being stuffed, the product shall be held ing, to all of the following minimum chamber temperatures and time periods. in a drying room not less than 35 days at a temperature not lower than 45 °F. TREATMENT SCHEDULE FOR SAUSAGES 55 MILLI- (iv) Hams and pork shoulder picnics. In METERS (21¤8 INCHES) OR LESS IN DIAMETER the curing of hams and pork shoulder picnics, one of the methods below shall Minimum chamber temperature Minimum time be used. For calculating days per (°F) (°C) (hours) pound, the establishment shall use the weight of the heaviest ham or picnic in 50 10 12 the lot. 100 37.8 1 125 51.7 6 Method No. 1. The hams and pork shoulder picnics shall be cured by a dry-salt curing Following the preceding heat treatment, the process not less than 40 days at a tempera- establishment shall dry the sausages at a ture no lower than 36 °F. The products shall temperature not lower than 50 °F (10 °C) for be laid down in salt, not less than 4 pounds not less than 4 days. to each hundredweight of product, the salt (ii) Capocollo (capicola, capacola). being applied in a thorough manner to the lean meat of each item. When placed in cure, Boneless pork butts for capocollo shall the products may be pumped with pickle if be cured in a dry-curing mixture con- desired. At least once during the curing proc- taining not less than 41⁄2 pounds of salt ess, the products shall be overhauled (turned per hundredweight of meat for a period over for the application of additional cure) of not less than 25 days at a tempera- and additional salt applied, if necessary, so ture not lower than 36 °F. If the curing that the lean meat of each item is thor- materials are applied to the butts by oughly covered. After removal from cure, the products may be soaked in water at a tem- the process known as churning, a small perature not higher than 70 °F for not more quantity of pickle may be added. Dur- than 15 hours, during which time the water ing the curing period the butts may be may be changed once, but they shall not be overhauled according to any of the subjected to any other treatment designed to usual processes of overhauling, includ- remove salt from the meat except that su- ing the addition of pickle or dry salt if perficial washing may be allowed. The prod- desired. The butts shall not be sub- ucts shall finally be dried or smoked at a time and temperature not less than a com- jected during or after curing to any bination prescribed in Table 5 of Method No. treatment designed to remove salt 3. from the meat, except that superficial Method No. 2. [Reserved] washing may be allowed. After being Method No. 3. (A) Curing. (Other than bag stuffed, the product shall be smoked curing): Establishments shall cure hams and for a period of not less than 30 hours at shoulders by using a cure mixture containing a temperature not lower than 80 °F., not less than 70 percent salt by weight to cover all exposed muscle tissue and to pack and shall finally be held in a drying the hock region. Total curing time consists room not less than 20 days at a tem- of a mandatory cure contact time and an op- perature not lower than 45 °F. tional equalization time. (iii) Coppa. Boneless pork butts for (B) Cure Contact Time. This is the cure con- coppa shall be cured in a dry-curing tact period, during which the establishment mixture containing not less than 41⁄2 shall keep exposed muscle tissue coated with pounds of salt per hundredweight of the cure mixture at least 28 days but for no less than 1.5 days per pound of ham or shoul- meat for a period of not less than 18 der. Overhaul is optional so long as the ex- days at a temperature not lower than posed muscle tissue remains coated with cur- 36 °F. If the curing mixture is applied ing mixture. to the butts by the process known as (C) Equalization. The establishment may churning, a small quantity of pickle provide an equalization period after the min- may be added. During the curing period imum cure contact period in (B) above to the butts may be overhauled according permit the absorbed salt to permeate the product’s inner tissues. Equalization is the to any of the usual processes of overtime after the excess cure has been removed hauling, including the addition of pick- from the product at the end of the cure con- le or dry salt if desired. The butts shall tact period until the product is placed in the not be subjected during or after curing drying room and the drying period begins.

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The total curing time (equalization plus cure curing time. If the product temperature ex- contact) shall be at least 40 days and in no ceeds 45 °F (7.2 °C) within the first period of case less than 2 days per pound of an uncured 1.5 days per pound of an uncured ham or ham or shoulder. shoulder or if it exceeds 60 °F (15.6 °C) for the (D) Removing Excess Cure. After the re- remainder of the curing period, the estab- quired cure contact period, the establish- lishment shall cool the product back to the ment may remove excess cure mixture from 45 °F (7.2 °C) maximum during the first pe- the product’s surface mechanically or by riod or 55 °F (12.8 °C) maximum during the rinsing up to 1 minute with water, but not by remainder of the period. soaking. (3) The establishment shall begin curing (E) Bag Curing. Bag curing is a traditional product only between the dates of December ham curing technique in which the manufac- 1 and February 13. The room temperature turer wraps the ham and all of the cure mix- need not be controlled, but the establish- ture together in kraft paper then hangs them ment shall monitor and record daily room individually. The paper keeps the extra cure temperatures, and days in which the room mixture in close contact with the product temperature drops below 35 °F (1.7 °C) shall making reapplication of salt unnecessary, not be counted as curing time. and it protects the product from mites and (G) Drying. After the curing period, estab- insects. Establishments may employ the bag lishments shall use one of three procedures curing method as an alternative to (A) for drying: through (D) above. An establishment which elects to use the bag curing method shall (1) The establishment shall subject the apply a cure mixture containing at least 6 product to a controlled room temperature pounds of salt per 100 pounds of uncured for a minimum time and minimum tempera- product. The establishment shall rub the ture combination prescribed in Table 5 or for curing mixture into the exposed muscle tis- a set of such combinations in which the total sue, pack the hock region with the curing of the fractional periods (in column 4 of mixture, and use uncoated wrapping paper to Table 5) exceeds 1.5. wrap the product together with any remain- (2) Establishments using uncontrolled ing curing mixture. The bag cured product room temperatures shall monitor and record shall remain wrapped throughout the curing the internal product temperature. The dry- period and may or may not remain wrapped ing period shall be complete when, from the during the drying period. In any case, the days which can be counted as curing time, curing period shall be at least 40 days but one of the time/temperature combinations of not less than 2 days per pound of an uncured Table 5 is satisfied or when the total of the ham or shoulder. After curing, the cured fractional values for the combinations ex- product shall be exposed to a drying time ceeds 1.5. and temperature prescribed in Table 5. (3) Establishments using uncontrolled (F) Curing Temperature. During the curing room temperatures shall dry the product for period the establishment shall use one of the a minimum of 160 days including the entire following procedures: months of June, July, and August. This pro- (1) The establishment shall control the cedure is obviously dependent on local cli- room temperature at not less than 35 °F (1.7 matic conditions and no problem exists with °C) nor greater than 45 °F (7.2 °C) for the first respect to current producers who use this 1.5 days per pound of an uncured ham or procedure. Future applicants shall dem- shoulder, and not less than 35 °F (1.7 °C) nor onstrate that their local monthly average greater than 60 °F (15.6 °C) for the remainder temperatures and the local monthly mini- of the curing period. mum temperatures are equal to or warmer (2) The establishment shall monitor and than the normal average temperatures and record daily product temperature. The room normal minimum temperatures compiled by temperature need not be controlled but days the National Oceanic and Atmospheric Ad- on which the product temperature drops ministration for Boone, North Carolina, sta- below 35 °F (1.7 °C) shall not be counted as tion 31–0977, 1951 through 1980.

MONTHLY TEMPERATURES (°F) FOR BOONE NC, 1951±1980

Jan. Feb. Mar. Apr. May June July Aug. Sep.

Normal average temperatures

32.2 34.1 41.3 51.2 59.1 65.1 68.3 67.5 61.6

Normal minimum temperatures

22.8 24.2 30.8 39.6 48.1 54.7 58.5 57.6 51.6

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Drying Times and Temperatures for (F) Drying. After the curing period, estab- Trichina Inactivation in Hams and lishments shall use one of the controlled Shoulders temperature methods for drying listed in Method No. 3 of this subparagraph. TABLE 5.ÐMINIMUM DRYING DAYS AT A Method No. 5 MINIMUM TEMPERATURE* (A) Curing. The establishment shall cure the ham to a minimum brine concentration Minimum Drying Temperature Minimum days Fractional period for of 6 percent by the end of the drying period. Degrees fahr- Degrees at drying tem- one day of enheit centigrade perature drying Brine concentration is calculated as 100 times the salt concentration divided by the 130 ...... 54.4 1.5 .67 sum of the salt and water concentrations. 125 ...... 51.7 2 .50 Percent brine=100×[salt]/([salt]+[water]) 120 ...... 48.9 3 .33 115 ...... 46.1 4 .25 The Agency will accept the brine con- 110 ...... 43.3 5 .20 centration in the biceps femoris as a reason- 105 ...... 40.6 6 .17 able estimate of the minimum brine con- 100 ...... 37.8 7 .14 centration in the ham. 95 ...... 35.0 9 .11 (B) Drying and Total Process Times. The es- 90 ...... 32.2 11 .091 tablishment shall dry the cured ham at a 85 ...... 29.4 18 .056 ° ° 80 ...... 26.7 25 .040 minimum temperature of 55 F (13 C) for at 75 ...... 23.9 35 .029 least 150 days. The total time of drying plus curing shall be at least 206 days. * Interpolation of these times or temperatures is not acceptable; establishments wishing to use temperatures or times not (C) Ensuring an Acceptable Internal Brine in this Table shall first validate their efficacy as provided by Concentration. (1) To establish compliance, 318.10(c)(4) of this section. the establishment shall take product samples from the first 12 lots of production as Method No. 4. follows: From each lot, (A) Cure: Establishments shall cure hams (i) One sample shall be taken from each of and shoulders by using a cure mixture con- 5 or more hams; taining not less than 71.5 percent salt by (ii) Each sample shall be taken from the weight to cover all exposed muscle tissue biceps femoris. As an alternative to the use and to pack the hock region. Establishments of the biceps femoris, the Agency shall con- may substitute potassium chloride (KCl) for sider other method(s) of sampling the dry- up to half of the required salt on an equal cured hams to determine the minimum in- weight basis. ternal brine concentration, as long as the es- (B) Curing. Establishments shall apply the tablishment proposes it and submits data cure at a rate not less than 5.72 pounds of and other information to establish its suffi- salt and KCl per hundred pounds of fresh ciency to the Director of the Processed Prod- meat. The cure shall be applied in either ucts Inspection Division; three or four approximately equal amounts (iii) Each sample shall weigh no less than (two or three overhauls) at separate times 100 grams; during the first 14 days of curing. (iv) The samples shall be combined as one (C) Cure Contact Time. Establishments shall composite sample and sealed in a water keep the product in contact with the cure vapor proof container; mixture for no less than 2 days per pound of (v) The composite sample shall be submit- an uncured ham or shoulder but for at least ted to a laboratory accredited under the pro- 30 days. Establishments shall maintain the visions of § 318.21 to be analyzed for salt and curing temperature at no less than 35°F water content using methods from the ‘‘Offi- (1.7°C) during the cure contact time. cial Methods of Analysis of the Association (D) Equalization. After the cure contact pe- of Official Analytical Chemists (AOAC),’’ riod, establishments shall provide an added 15th Edition, 1990, Section 983.18 (page 931) equalization period of no less than 1 day per and Section 971.19 (page 933) which are incor- pound of an uncured ham or shoulder but at porated by reference. This incorporation by least 14 days. Equalization is the time after reference was approved by the Director of the excess cure has been removed from the the Federal Register in accordance with 5 product, the end of the cure contact period, U.S.C. 552(a) and 1 CFR part 51. Copies may and before the drying period begins. Estab- be obtained from the Association of Official lishments may substitute additional cure Analytical Chemists, suite 400–BW, 2200 Wil- contact days for an equal number of equali- son Boulevard, Arlington, VA 22201–3301. Cop- zation days. ies may be inspected at the Office of the (E) Removing Excess Cure. After the re- FSIS Hearing Clerk, room 3171, South Agri- quired cure contact period, the establish- culture Building, Food Safety and Inspection ment may remove excess cure mixture from Service, U.S. Department of Agriculture, the product’s surface mechanically or by Washington, DC 20250 or at the Office of the rinsing up to 1 minute with water, but not by Federal Register, 800 North Capitol Street, soaking. NW., suite 700, Washington, DC 20408. If the

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time between sampling and submittal of the sider other methods of sampling the dry- composite sample to the accredited labora- cured hams to determine internal brine con- tory will exceed 8 hours, then the establish- centration, as long as the establishment pro- ment shall freeze the composite sample imposes it and submits data and other informa- mediately after the samples are combined; tion to establish its sufficiency to the Direc- (vi) Once the laboratory results for the tor of the Processed Products Inspection Di- composite sample are received, the manufac- vision; turer shall calculate the internal brine con- (iii) Each sample shall weigh no less than centration by multiplying the salt con- 100 grams; centration by 100 and then dividing that fig- (iv) The samples shall be combined as one ure by the sum of the salt and water con- composite sample and sealed in a water centrations; vapor proof container; (vii) Compliance is established when the (v) The composite sample shall be submit- samples from the first 12 lots of production ted to a laboratory accredited under the pro- have a minimum internal brine concentra- visions of § 318.21 to be analyzed for salt and tion of 6 percent. Lots being tested to estab- water content using methods from the ‘‘Offi- lish compliance shall be held until the inter- cial Methods of Analysis of the Association nal brine concentration has been determined of Official Analytical Chemists (AOAC),’’ and found to be at least 6 percent. If the min- 15th Edition, 1990, section 983.18 (page 931) imum internal brine concentration is less and section 971.19 (page 933) which are incor- than 6 percent, the lot being tested shall be porated by reference. This incorporation by held until the establishment brings the lot reference was approved by the Director of into compliance by further processing. the Federal Register in accordance with 5 (2) To maintain compliance, the establish- U.S.C. 552(a) and 1 CFR part 51. Copies may ment shall take samples, have the samples be obtained from the Association of Official analyzed, and perform the brine calculations Analytical Chemists, suite 400–BW, 2200 Wil- as set forth above from one lot every 13 son Boulevard, Arlington, VA 22201–3301. Cop- weeks. Lots being tested to maintain compli- ies may be inspected at the Office of the ance shall not be held. If the minimum inter- FSIS Hearing Clerk, room 3171, South Agri- nal brine concentration is less than 6 percent culture Building, Food Safety and Inspection in a lot being tested to maintain compliance, Service, U.S. Department of Agriculture, the establishment shall develop and propose Washington, DC 20250 or at the Office of the steps acceptable to FSIS to ensure that the Federal Register, 800 North Capitol Street, process is corrected. NW., suite 700, Washington, DC. If the time (3) Accredited laboratory results and the between sampling and submittal of the com- brine calculations shall be placed on file at posite sample to the accredited laboratory the establishment and available to Program will exceed 8 hours, then the establishment employees for review. shall freeze the composite sample immediately after the samples are combined; Method No. 6 (vi) Compliance is established when the (A) Curing. The establishment shall cure samples from the first 12 lots of production the ham to a minimum brine concentration have a minimum internal brine concentra- of 6 percent by the end of the drying period. tion of 6 percent. Lots being tested to estab- Brine concentration is calculated as 100 lish compliance shall be held until the inter- times the salt concentration divided by the nal brine concentration has been determined sum of the salt and water concentrations. and found to be at least 6 percent. If the min- Percent brine = 100 × [salt] / ([salt] + [water]) imum internal brine concentration is less The Agency will accept the brine con- than 6 percent, the lot being tested shall be centration in the biceps femoris as a reason- held until the establishment brings the lot able estimate of the minimum brine con- into compliance by further processing. centration. (2) To maintain compliance, the establish- (B) Drying and Total Process Times. The es- ment shall take samples, have the samples tablishment shall dry the cured ham at a analyzed, and perform the brine calculations minimum temperature of 110 °F (43 °C) for at as set forth above from one lot every 13 least 4 days. The total time of drying plus weeks. Lots being tested to maintain compli- curing shall be at least 34 days. ance shall not be held. If the minimum inter- (c) Ensuring an Acceptable Internal Brine nal brine concentration is less than 6 percent Concentration. in a lot being tested to maintain compliance, (1) To establish compliance the establish- the establishment shall develop and propose ment shall take product samples from the steps acceptable to FSIS to ensure that the first 12 lots of production as follows: From process is corrected. each lot, (3) Accredited laboratory results and the (i) One sample shall be taken from each of brine calculations shall be placed on file in 5 or more hams; the establishment and available to Program (ii) Each sample shall be taken from the employees for review. biceps femoris. As an alternative to the use (v) Boneless pork loins and loin ends. of the biceps femoris, the Agency will con- In lieu of heating or refrigerating to

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destroy possible live trichinae in and require discontinuance of use, for boneless loins, the loins may be cured purposes of the regulations in this sub- for a period of not less than 25 days at chapter, any thermometers (including a temperature not lower than 36 °F. by any automatic recording thermom- the use of one of the following meth- eters) of the establishment that are ods: found to be inaccurate or unreliable. Method No. 1. Application of a dry-salt cur- (e) The requirements for using the ing mixture containing not less than 5 pooled sample digestion technique to pounds of salt to each hundredweight of analyze pork for the presence of tri- meats. china cysts are: Method No. 2. Application of a pickle solu- (1) The establishment shall submit tion of not less than 80° strength (salometer) for the approval of the Regional Direc- on the basis of not less than 60 pounds of tor its proposed procedure for identify- pickle to each hundredweight of meat. Method No. 3. Application of a pickle solu- ing and pooling carcasses, collecting tion added to the dry-salt cure prescribed as and pooling samples, testing samples Method No. 1 in this subdivision (v) provided (including the name and address of the the pickle solution is not less than 80° laboratory), communicating test re- strength (salometer). sults, retesting individual carcasses, After removal from cure, the loins may be and maintaining positive identification soaked in water for not more than 1 hour at and clear separation of pork found to a temperature not higher than 70 °F. or washed under a spray but shall not be sub- be trichina-free from untested pork or jected, during or after the curing process, to trichina-positive pork. any other treatment designed to remove (2) The establishment shall use the salt. services of a laboratory approved by Following curing, the loins shall be the Administrator for all required test- smoked for not less than 12 hours. The mini- ing. Such approval shall be based on mum temperature of the smokehouse during adequacy of facilities, reagents, and this period at no time shall be lower than 100 °F., and for 4 consecutive hours of this period equipment, and on demonstration of the smokehouse shall be maintained at a continuing competency and reliability temperature not lower than 125 °F. in performing the pooled sample diges- Finally, the product shall be held in a dry- tion technique for trichinae. ing room for a period of not less than 12 days (3) The establishment shall sample no at a temperature not lower than 45 °F. less than 5 grams of diaphragm muscle (4) The Administrator shall consider or tongue tissue from each carcass or additional processing methods upon pe- no less than 10 grams of other muscle tition by manufacturers, and shall ap- tissue. Samples may be pooled but a prove any such method upon his/her de- pool shall not consist of more than 100 termination that it can be properly grams of sample. Sampling and sample monitored by an inspector and that the preparation are subject to inspection safety of such methods is adequately supervision. documented by data which has been de- (4) Pork or products made from test- veloped by following an experimental ed pork shall not be released as tri- protocol previously reviewed and ac- china free from the official establish- cepted by the Department. ment without treatment until the in- (d) General instructions: When nec- spector in charge receives a laboratory essary to comply with the require- report that the tested pork is free of ments of this section, the trichina cysts. smokehouses, drying rooms, and other (f) Approval of other tests for trichinosis compartments used in the treatment of in pork. The Administrator shall con- pork to destroy possible live trichinae sider any additional analytical method shall be suitably equipped, by the oper- for trichinosis upon petition by a man- ator of the official establishment, with ufacturer, and may approve that meth- accurate automatic recording ther- od upon the determination that it will mometers. Circuit supervisors are au- detect at least 98 percent of swine bear- thorized to approve for use in sausage ing cysts present at a tissue density smokehouses, drying rooms, and other equal to or less than one cyst per gram compartments, such automatic record- of muscle from the diaphragm pillars ing thermometers as are found to give at a 95 percent confidence level. Any satisfactory service and to disapprove such petitions shall be supported by

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any data and other information that the regulations in this subchapter to be the Administrator finds necessary. No- prepared for human food (e.g., lungs or tice of any approval shall be given in intestines), which are produced at any the FEDERAL REGISTER, and the ap- official establishment, may be brought proved method will be incorporated into the inedible products department into this section. of any official establishment for use in [35 FR 15586, Oct. 3, 1970, as amended at 38 FR uninspected articles under this section. 31517; Nov. 15, 1973; 39 FR 40580, Nov. 19, 1974; The uninspected article may be stored 50 FR 5229, Feb. 7, l985; 50 FR 48075, Nov. 21, in, and distributed from, edible product 1985; 52 FR 12517, Apr. 17, 1987; 57 FR 27874, departments: Provided, That adequate June 22, 1992; 57 FR 33633, July 30, 1992; 57 FR facilities are furnished, there is no in- 56440, Nov. 30, 1992] terference with the maintenance of sanitary conditions, and such article is § 318.11 [Reserved] properly identified. § 318.12 Manufacture of dog food or (b) When dog food or similar similar uninspected article at offi- uninspected article is manufactured in cial establishments. a part of an official establishment (a) When dog food, or similar other than an edible product depart- uninspected article is manufactured in ment, the area in which the article is an edible product department, there manufactured shall be separated from shall be sufficient space allotted and edible product departments in the man- adequate equipment provided so that ner required for separation between ed- the manufacture of the uninspected ar- ible product departments and inedible ticle in no way interferes with the han- product departments. Sufficient space dling or preparation of edible products. must be allotted and adequate equip- Where necessary to avoid adulteration ment provided so that the manufacture of edible products, separate equipment of the uninspected article does not shall be provided for the uninspected interfere with the proper functioning of article. To assure the maintenance of the other operations at the establish- sanitary conditions in the edible prod- ment. Except as provided in § 314.11 of uct departments, the operations inci- this subchapter, nothing in this para- dent to the manufacture of the graph shall be construed as permitting uninspected article will be subject to any deviation from the requirement the same sanitary requirements that that dead animals, condemned prod- apply to all operations in edible products, and similar materials of whatever uct departments. The manufacture of origin, must be placed in the inedible the uninspected article shall be limited product rendering equipment, and to those hours during which the estab- without undue delay. The manufacture lishment operates under inspectional of the uninspected article must be such supervision; and there shall be no han- as not to interfere with the mainte- dling, other than receiving at the offi- nance of general sanitary conditions on cial establishment, of any of the prod- the premises, and it shall be subject to uct ingredient of the uninspected arti- inspectional supervision similar to cle, other than during the regular that exercised over other inedible prod- hours of inspection. The materials used uct departments. There shall be no in the manufacture of the uninspected movement of any product from an ined- article shall not be used so as to inter- ible product department to any edible fere with the inspection of edible prod- product department. Trucks, barrels, uct or the maintenance of sanitary and other equipment shall be cleaned conditions in the department or render before being returned to edible product any edible product adulterated. The departments from inedible product de- meat, meat byproducts, and meat food partments. Unoffensive material pre- product ingredients of the uninspected pared outside edible product depart- article may be admitted into any edi- ments may be stored in, and distrib- ble products department of an official uted from, edible product departments establishment only if they are U.S. In- only if packaged in clean, properly spected and Passed. Products within identified, sealed containers. § 314.11 of this subchapter or parts of (c) Animal food shall be distin- carcasses of kinds not permitted under guished from articles of human food, so

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as to avoid distribution of such animal promptly by the official establishment food as human food. To accomplish under supervision of an inspector and this, such animal food shall be labeled rehandled as follows: or otherwise identified in accordance (1) Separate and condemn all product with § 325.11(d) of this subchapter. in damaged or extensively rusted con- [35 FR 15586, Oct. 3, 1970, as amended at 36 FR tainers. 11639, June 17, 1971; 53 FR 24679, June 30, 1988] (2) Remove paper labels and wash the remaining containers in warm soapy § 318.13 Mixtures containing product water, using a brush where necessary but not amendable to the Act. to remove rust or other foreign mate- Mixtures containing product but not rial. Disinfect these containers by ei- classed as a meat food product under ther of the following methods: the Act shall not bear the inspection (i) Immerse in a solution of sodium legend or any abbreviation or represen- hypochlorite containing not less than tation thereof unless manufactured 100 p/m of available chlorine or other under the food inspection service pro- equivalent disinfectant approved by vided for in part 350 of subchapter B of the Administrator, 1 rinse in potable this chapter. When such mixtures are water, and dry thoroughly; or manufactured in any part of an official (ii) Immerse in 212 °F. water, bring establishment, the sanitation of that temperature of the water back to 212 part of the establishment shall be su- °F. and maintain the temperature at pervised by Program employees, and 212 °F. for 5 minutes, then remove con- the manufacture of such mixtures shall tainers from water and cool them to 95 not cause any deviation from the re- °F. and dry thoroughly. quirement of § 318.1. (3) After handling as described in paragraph (c)(2) of this section, the [35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973] containers may be relacquered, if necessary, and then relabeled with ap- § 318.14 Adulteration of product by proved labels applicable to the product polluted water; procedure for han- therein. dling. (4) The identity of the canned prod- (a) In the event there is polluted uct shall be maintained throughout all water (including but not limited to stages of the rehandling operations to flood water) in an official establish- insure correct labeling of the contain- ment, all products and ingredients for ers. use in the preparation of such products [35 FR 15586, Oct. 3, 1970, as amended at 38 FR that have been rendered adulterated by 34455, Dec. 14, 1973] the water shall be condemned. (b) After the polluted water has re- § 318.15 Tagging chemicals, preserva- ceded from an official establishment, tives, cereals, spices, etc., ‘‘U.S. re- all walls, ceilings, posts, and floors of tained.’’ the rooms and compartments involved, When any chemical, preservative, ce- including the equipment therein, shall, real, spice, or other substance is in- under the supervision of an inspector, tended for use in an official establish- be cleaned thoroughly by the official ment, it shall be examined by a Pro- establishment personnel. An adequate gram employee and if found to be unfit supply of hot water under pressure is or otherwise unacceptable for the use essential to make such cleaning effec- intended, or if final decision regarding tive. After cleaning, a solution of so- acceptance is deferred pending labora- dium hypochlorite containing approxi- tory or other examination, the em- mately one-half of 1 percent available ployee shall attach a ‘‘U.S. retained’’ chlorine (5,000 p/m) or other equivalent tag to the substance or container disinfectant approved by the Adminis- thereof. The substance so tagged shall trator 1 shall be applied to the surface of the rooms and equipment and rinsed 1 A list of approved disinfectants is avail- with potable water before use. able upon request to Scientific Services, (c) Hermetically sealed containers of Meat and Poultry Inspection Program, Food product which have been contaminated Safety and Inspection Service, U.S. Depart- by polluted water shall be examined ment of Agriculture, Washington, DC 20250.

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be kept separate from other substances tained in all parts of each piece of as the circuit supervisor may require meat for at least the stated time: and shall not be used until the tag is removed, and such removal shall be TABLE FOR TIME/TEMPERATURE COMBINATION made only by a Program employee FOR COOKED BEEF, ROAST BEEF, AND after a finding that the substance can COOKED CORNED BEEF be accepted, or, in the case of an unac- Minimum internal temperature ceptable substance, when it is removed Minimum processing time Degrees Fahr- Degrees Cen- in minutes after minimum from the establishment. enheit tigrade temperature is reached

§ 318.16 Pesticide chemicals and other 130 54.4 121 residues in products. 131 55.0 97 132 55.6 77 (a) Nonmeat ingredients. Residues of 133 56.1 62 pesticide chemicals, food additives and 134 56.7 47 color additives or other substances in 135 57.2 37 136 57.8 32 or on ingredients (other than meat, 137 58.4 24 meat byproducts, and meat food prod- 138 58.9 19 ucts) used in the formulation of prod- 139 59.5 15 ucts shall not exceed the levels per- 140 60.0 12 141 60.6 10 mitted under the Federal Food, Drug, 142 61.1 8 and Cosmetic Act, and such nonmeat 143 61.7 6 ingredients must otherwise be in com- 144 62.2 5 pliance with the requirements under 145 62.8 Instantly that Act. (b) Cooked beef, including sectioned (b) Products, and meat, meat byproduct, and formed roasts and chunked and or other meat food product ingredients. formed roasts, and cooked corned beef Products, and products used as ingredi- shall be moist cooked throughout the ents of products, shall not bear or con- process or, in the case of roast beef or tain any pesticide chemical, food addi- corned beef to be roasted, cooked as tives, or color additive residue in ex- provided in paragraph (c) of this sec- cess of the level permitted under the tion. The moist cooking may be accom- Federal Food, Drug, and Cosmetic Act plished by (1) placing the meat in a and the regulations in this subchapter, sealed, moisture impermeable bag, re- or any other substance that is prohib- moving the excess air, and cooking, (2) ited by such regulations or that other- completely immersing the meat, wise makes the products adulterated. unbagged, in water throughout the en- (c) Standards and procedures. Instruc- tire cooking process, or (3) using a tions specifying the standards and pro- sealed oven or steam injection to raise cedures for determining when ingredi- the relative humidity above 90 percent ents of finished products are in compli- throughout the cooking process. ance with this section shall be issued (c) Roast beef or corned beef to be to the inspectors by the Administrator. roasted shall be cooked by one of the Copies of such instructions will be following methods: made available to interested persons (1) Heating roasts of 10 pounds or upon request made to the Adminis- more in an oven maintained at 250 °F trator. (121 °C) or higher throughout the process; § 318.17 Requirements for the produc- (2) Heating roasts of any size to a tion of cooked beef, roast beef, and minimum internal temperature of 145 cooked corned beef. °F (62.8 °C) in an oven maintained at (a) Cooked beef and roast beef, in- any temperature if the relative humid- cluding sectioned and formed roasts ity of the oven is maintained either by and chunked and formed roasts, and continuously introducing steam for 50 cooked corned beef shall be prepared by percent of the cooking time or by use one of the time and temperature com- of a sealed oven for over 50 percent of binations in the following table. The the cooking time, or if the relative hu- stated temperature is the minimum midity of the oven is maintained at 90 which shall be produced and main- percent or above for at least 25 percent

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of the total cooking time, but in no (3) The storage time and temperature case less than 1 hour; or combinations which the establishment (3) Heating roasts of any size in an intends to use before cooking, the oven maintained at any temperature cooking time and temperature the es- that will satisfy the internal tempera- tablishment intends to use, and the ture and time requirements of para- time, if any, the establishment intends graph (a) of this section if the relative to wait after cooking and before cool- humidity of the oven is maintained at ing. 90 percent or above for at least 25 per- (4) If a code, instead of the calendar cent of the total cooking time, but in date, is used on the immediate con- no case less than 1 hour. tainer of the finished product, its The relative humidity may be meaning shall also be included. achieved by use of steam injection or (5) Any other critical control points by sealed ovens capable of producing in the procedures which could affect and maintaining the required relative the safety of the product. humidity. (6) In lieu of recording devices, the (d)(1) Except as provided in para- alternate means permitted by graph (d)(2) of this section, establish- § 318.17(d)(2) of providing evidence to in- ments producing cooked beef, roast spection personnel that the finished beef, or cooked corned beef shall have product will be prepared in compliance sufficient monitoring equipment, in- with temperature or humidity require- cluding recording devices, to assure ments. that the time (within 1 minute), the (7) Any other alternate procedure temperature (within 1 °F), and relative used that is permitted in this section. humidity (within 5 percent) limits of (g) The establishment shall maintain these processes are being met. Data records and reports which document from the recording devices shall be the time, temperature, and humidity made available to a program employee at which any cooked beef, roast beef, or upon request. cooked corned beef is cooked and (2) In lieu of recording devices, estab- cooled at the establishment. Such lishments may propose in the written records shall be kept by the establish- procedures prescribed in paragraph (f) ment for 6 months or for such further of this section, an alternative means of period as the Administrator may re- providing inspection personnel with quire for purposes of any investigation evidence that finished product has been or litigation under the Act, by written prepared in compliance with the hu- notice to the person required to keep midity requirements of paragraphs (b) such records. Such records shall be and (c) of this section, and the 145 °F made available to the inspector or any (62.8 °C) temperature requirements of duly authorized representative of the paragraph (a) of this section. Secretary upon request. (e) Each package of finished product (h) The handling and processing of shall be plainly and permanently cooked beef, roast beef, and cooked marked on the immediate container corned beef before, during, and after with the date of production either in cooking shall be such as to prevent the code or with the calendar date. finished product from being adulter- (f) In order to assure that cooked ated. As a minimum, they shall be beef, roast beef, and cooked corned beef controled as follows: are handled, processed, and stored (1) The establishment shall notify the under sanitary conditions, the estab- inspector-in-charge which processing lishment shall submit a set of written procedure will be used on each lot, in- procedures through the inspector-including time and temperature. charge for approval by the Regional Di- (2) In order to assure uniform heat rector. The written procedures shall in- penetration and consequent adequate clude the following information: cooking of each piece of beef, individ- (1) The temperature to which raw fro- ual pieces of raw product in any one lot zen product is thawed and the time re- shall either not vary in weight by more quired. than 2 pounds or not vary in thickness (2) The lot identification procedure by more than 2 inches at the thickest for lots of product during processing. part. Alternate methods of assuring

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uniform heat penetration may be sub- (11) Any establishment that has expe- mitted in writing for approval to the rienced a cooking process deviation Regional Director. during preparation of product may ei- (3) A water-based solution that is ther reprocess the product completely, used for injecting or immersing the continue the heating to 145 °F (62.8 °C), meat shall be refrigerated to 50 °F (10 or contact the Regional Director for a °C) or lower from the time it contacts review of the process schedule for ade- the meat, and shall be filtered each quacy and, if needed, for a cooking time it is recirculated or reused. schedule to finish that one batch of (4) A nonmeat ingredient, including product. the water-based solution in (h)(3) (12) An establishment that has expe- above, which has contacted meat shall rienced a cooling deviation after the be discarded at the end of that day’s product has been cooked shall contact production unless it is in continuous the Regional Director to determine the contact with one batch of product. disposition of that retained product. (5) Product prepared for cooking (i) Cooked beef, roast beef, and shall be entered into the cooking cycle cooked corned beef shall be so handled within 2 hours of completion of as to assure that the product is not re- precooking preparation, or be placed contaminated by direct contact with immediately in a cooler at a tempera- raw product. To prevent direct con- ture of 40 °F (4.4 °C) or lower. tamination of the cooked product, es- (6) The time and temperature re- tablishments shall: quirements shall be met before any (1) Physically separate areas where product in the lot is removed from the raw product is handled from areas cooking units. Unless otherwise speci- where exposed cooked product is han- fied in the written procedures approved dled, using a solid impervious floor to in accordance with paragraph (f) of this ceiling wall; or section, the heat source shall not be (2) Handle raw and exposed cooked shut off until these requirements are product at different times, with a met. cleaning of the entire area after the (7) Other than incidental contact raw material handling is completed caused by water currents during im- and prior to the handling of cooked mersion cooking or cooling, product product in that area; or shall be placed so that it does not (3) Submit a written procedure for touch or overlap other products. This approval through the inspector-in- provision does not apply to product charge to the Circuit Supervisor detail- that is stirred or agitated to assure ing the steps to be taken which would uniform heat transfer. avoid recontamination of cooked prod- (8) Temperature sensing devices shall uct by raw product during processing. be so placed that they monitor product (j) To prevent indirect contamination in the coldest part of the cooking unit; of cooked product: and when an oven temperature is re- (1) Any work surface, machine, or quired by paragraph (c) of this section, tool which contacts raw product shall the oven temperature shall also be be thoroughly cleaned and sanitized monitored in the coldest part of the with a solution germicidally equiva- cooking unit. lent to 50 ppm chlorine before it con- (9) If a humidity sensing device is re- tacts cooked product; quired in an oven, it shall be placed so (2) Employees shall wash their hands that it measures humidity in either the and sanitize them with a solution ger- oven chamber or at the exit vent. micidally equivalent to 50 ppm chlo- (10) Chilling shall begin within 90 rine whenever they enter the heat minutes after the cooking cycle is processed product area or before pre- completed. paring to handle cooked product, and (i) All product shall be chilled from as frequently as necessary during oper- 120 °F (48.8 °C) to 55 °F (12.7 °C) in no ations to avoid product contamination; more than 6 hours. and (ii) Chilling shall continue and the (3) Outer garments, including aprons, product shall not be packed for ship- smocks, and gloves, shall be especially ment until it has reached 40 °F (4.4 °C). identified as restricted for use in

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cooked product areas only, changed at which does not fit into Group I but does fit least daily, and hung in a designated into Group II will be placed into Group II re- location when the employee leaves the gardless of any other considerations. area. Group III, consisting of boneless smoke- (k) Cooked product shall not be house heated cured pork products. Any stored in the same room as raw product boneless product that does not fit into Group unless it is first packaged in a sealed, I or Group II shall be placed in Group III. water-tight container or is otherwise Group IV, consisting of bone-in or semi- protected by a covering that has been boneless smokehouse heated cured pork products. Any product that is not completely approved, upon written request, by the boneless or still contains all the bone which Circuit Supervisor. is traditional for bone-in product, and does not fit into Group I, Group II, or Group III (Approved by the Office of Management and shall be placed in this Group. Budget under control number 0583–0015) [48 FR 24316, June 1, 1983] (3) A lot is that product from one production shift. § 318.18 Handling of certain material (4) A production rate is frequency of for mechanical processing. production, expressed in days per week. Material to be processed into ‘‘Me- (5) Protein fat free percentage, protein chanically Separated (Species)’’ shall fat free content, PFF percentage, PFF be so processed within 1 hour from the content or PFF of a product means the time it is cut or separated from car- meat protein (indigenous to the raw, casses or parts of carcasses, except unprocessed pork cut) content ex- that such product may be held for no pressed as a percent of the non-fat por- more than 72 hours at 40 °F. (4 °C.) or tion of the finished product. less, or held indefinitely at 0 °F. (¥18 °C.) or less. ‘‘Mechanically Separated (b) Normal Compliance Procedures. The (Species)’’ shall, directly after being Department shall collect samples of processed, be used as an ingredient in a cured pork products and analyze them meat food product except that it may for their PFF content. Analyses shall be held prior to such use for no more be conducted in accordance with the than 72 hours at 40 °F. (4 °C.) or less or ‘‘Official Methods of Analysis of the indefinitely at 0 °F. (¥18 °C.) or less. Association of Official Analytical Chemists §§ 950.46, and 928.08 (Chapter [43 FR 26423, June 20, 1978, as amended at 47 39).1 The ‘‘Official Methods of Analysis FR 28256, June 29, 1982] of the Association of Official Analyt- § 318.19 Compliance procedure for ical Chemists,’’ 15th edition, 1990, is in- cured pork products. corporated by reference with the approval of the Director of the Federal (a) Definitions. For the purposes of this section: Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Each analyt- (1) A product is that cured pork article which is contained within one ical result shall be recorded and evalu- Group as defined in paragraph (a)(2) of ated to determine whether future sam- this section and which purports to pling of product Groups within an offi- meet the criteria for a single product cial establishment shall be periodic or designated under the heading ‘‘Product daily under the provisions of paragraph Name and Qualifying Statements’’ in (b)(1) of this section, and if the affected the chart in § 319.104 or the chart in lot and subsequent production of like § 319.105. (2) A Product Group or a Group means one of the following: 1 A copy of the ‘‘Official Methods of Analy- Group I, consisting of cured pork products sis of the Association of Official Analytical which have been cooked while imperviously Chemists,’’ 15th edition, 1990, is on file with encased. Any product which fits into the the Director, Office of the Federal Register, Group will be placed in this Group regardless and may be purchased from the Association of any other considerations. of Official Analytical Chemists, Inc., 2200 Group II, consisting of cured pork products Wilson Boulevard, Suite 400, Arlington, Vir- which have been water cooked. Any product ginia 22201.

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product shall be U.S. retained, or ad- (iii) Add 0.25 to the Standardized Dif- ministratively detained, as appro- ference to find the Adjusted Standard- priate, as provided in paragraph (b)(2) ized Difference. of this section.2 (iv) Use the lesser of 1.90 and the Ad- (1) Criteria to determine sampling fre- justed Standardized Difference as the quency of Product Groups. For each offi- Sample Value. cial plant preparing cured pork prod- (v) Cumulatively total Sample Val- ucts, Product Groups shall be sampled ues to determine the Group Value. The periodically or daily. Analytical re- first Sample Value in a Group shall be sults shall be evaluated and the sam- the Group Value, and each succeeding pling frequency determined as follows: Group Value shall be determined by (i) Determine the difference between adding the most recent Sample Value the individual PFF analysis and the to the existing Group Value; provided, applicable minimum PFF percentage however, that in no event shall the requirement of § 319.104 or § 319.105. The Group Value exceed 1.00. When calcula- resulting figure shall be negative when tion of a Group Value results in a fig- the individual sample result is less ure greater than 1.00, the Group Value than the applicable minimum PFF per- shall be 1.00 and all previous Sample centage requirement and shall be posi- Values shall be ignored in determining tive when the individual sample result future Group Values. is greater than the applicable mini- (vi) The frequency of sampling of a mum PFF percentage requirement. Group shall be periodic when the Group (ii) Divide the resulting number by Value is greater than ¥1.40 (e.g., ¥1.39, the standard deviation assigned to the ¥1.14, 0, 0.50, etc.) and shall be daily Product Group represented by the sam- when the Group Value is ¥1.40 or less ple to find the Standardized Difference. (e.g., ¥1.40, ¥1.45, ¥1.50, etc.); pro- The standard deviation assigned to vided, however, that once daily sampling has been initiated, it shall con- Groups I and II is 0.75 and to Groups III tinue until the Group Value is 0.00 or and IV is 0.91. greater, and each of the last seven Sample Values is ¥1.65 or greater (e.g., 2 Rules for Rounding: ¥1.63, ¥1.50, etc.), and there is no 1. Laboratory results for percent meat pro- other product within the affected tein and fat will be reported to the second Group being U.S. retained as produced, decimal place (hundredths). under provisions of paragraph (b)(2) or 2. PFF and Sample Values for charting (c). purposes will be calculated from the reported laboratory results to the second decimal (2) Criteria for U.S. retention or admin- place. Rounding of calculations to reach two istrative detention of cured pork products decimal places will be done by the following for further analysis. Cured prok prod- rule: ucts shall be U.S. retained, or adminis- All values of five-thousandths (0.005) or tratively detained, as appropriate, more will be rounded up to the next highest when prescribed by paragraphs (b)(2) (i) hundredth. All values of less than five-thou- or (ii) of this section as follows: sandths (0.005) will be dropped. (i) Absolute Minimum PFF Require- 3. For compliance with the Absolute Mini- ment. In the event that an analysis of mum PFF requirements, the PFF will be rounded to the first decimal place (tenths). an individual sample indicates a PFF Rounding of calculations to reach one deci- content below the applicable minimum mal place will be done by the following rule: requirement of § 319.104 or § 319.105 by All PFF values of five-hundredths (0.05) or 2.3 or more percentage points for a more will be rounded up to the next highest Group I or II product, or 2.7 or more tenth. All PFF values of less than five-hun- percentage points for a Group III or IV dredths (0.05) will be dropped. product, the lot from which the sample 4. For product disposition (pass-fail of a was collected shall be U.S. retained if minimum PFF standard for retained prod- in an official establishment and shall uct) the average PFF calculation will be be subject to administrative detention rounded to the first decimal place. Individ- ual PFF Values will be calculated to the if not in an official establishment un- nearest hundredth as in (2) above. The aver- less returned to an official establish- age, however, will be rounded to the nearest ment and there U.S. retained. Any sub- tenth as in (3) above. sequently produced lots of like product

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and any lots of like product for which ignored in determining future Product production dates cannot be established Values. shall be U.S. retained or subject to ad- (E) Provided daily group sampling is ministrative detention. Such adminis- in effect pursuant to the provisions of tratively detained product shall be paragraph (b)(1) of this section, and handled in accordance with part 329 of provided further the Product Value is this subchapter, or shall be returned to ¥1.65 or less (e.g., ¥1.66), the affected an official establishment and subjected lot (if within the official establish- to the provisions of paragraph (c)(1) (i) ment) and all subsequent lots of like or (ii) of this section, or shall be re- product prepared by and still within labeled in compliance with the applica- the official establishment shall be U.S. ble standard, under the supervision of a retained and further evaluated under program employee, at the expense of paragraph (c) of this section. Except the product owner. Disposition of such for release of individual lot pursuant to U.S. retained product shall be in ac- paragraph (c)(1), subsequently produced cordance with paragraph (c) of this sec- lots of like product shall continue to be tion. U.S. retained until discontinued pursu- (ii) Product Value requirement. The ant to paragraph (c)(2) of this section. Department shall maintain, for each (c) Compliance procedure during prod- product prepared in an official estab- uct retention. When a product lot is U.S. lishment, a Product Value. Except as retained under the provisions of para- provided in paragraph (c)(2) of this sec- graph (b)(2) of this section, the Depart- tion, calculation of the Product Value ment shall collect three randomly se- and its use to determine if a product lected samples from each such lot and shall be U.S. retained shall be as fol- analyze them individually for PFF con- lows: tent. The PFF content of the three (A) Determine the difference between samples shall be evaluated to deter- the individual PFF analysis and appli- mine disposition of the lot as provided cable minimum PFF percentage rein paragraph (c)(1) of this section and quirement of § 319.104 and § 319.105. The the action to be taken on subsequently resulting figure shall be negative when produced lots of like product as pro- the individual sample result is less vided in paragraph (c)(2) of this sec- than the applicable minimum PFF per- tion.3 centage requirement and shall be posi- (1) A product lot which is U.S. re- tive when the individual sample result tained under the provisions of para- is greater than the applicable mini- graph (b)(2) of this section may be re- mum PFF percentage requirement. leased for entry into commerce pro- (B) Divide the difference determined vided one of the following conditions is in paragraph (b)(2)(ii)(A) of this section met: by the standard deviation assigned to (i) The average PFF content of the the product’s Group in paragraph three samples randomly selected from (b)(1)(ii) of this section to find the the lot is equal to or greater than the standardized difference. applicable minimum PFF percentage (C) Use the lesser of 1.65 and the required by § 319.104 or § 319.105. Further standardized difference as the Sample processing to remove moisture for the Value. purpose of meeting this provision is (D) Cumulatively total Sample Val- permissible. In lieu of further analysis ues to determine the Product Value. to determine the effects of such proc- The first Sample Value of a product essing, each 0.37 percent weight reduc- shall be the Product Value, and each tion due to moisture loss resulting succeeding Product Value shall be determined by adding the most recent 3 If the processor does not wish to have the Sample Value to the existing Product product evaluated in this manner, alternate Value; provided, however, that in no sampling plans may be used provided such event shall the Product Value exceed plans have been formulated by the processor and approved by the Administrator prior to 1.15. When calculation of a Product evaluation by the three-sample criteria, and Value results in a figure greater than provided the analyses specified in such plans 1.15, the Product Value shall be 1.15, are performed at the expense of the proc- and all previous Sample Values shall be essor.

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from the processing may be considered 1.15, the Product Value shall be 1.15 and the equivalent of a 0.1 percent PFF all previous Sample Values shall be ig- gain. nored in determining future Product (ii) The lot of the product is relabeled Values. to conform to the provisions of § 319.104 (vi) New lots of like product shall or § 319.105, under the supervision of a continue to be retained pending dis- program employee. position in accordance with paragraph (iii) The lot is one that has been pre- (c)(1) of this section until, after 5 days pared subsequent to preparation of the of production, the Product Value is 0.00 lot which, under the provisions of para- or greater, and the PFF content of no graph (c)(2) of this section, resulted in individual sample from a U.S. retained discontinuance of U.S. retention of new lot is less than the Absolute Minimum lots of like product. Such lot may be PFF requirement specified in para- released for entry into commerce prior graph (b)(2)(i) of this section. Should to receipt of analytical results for an individual sample fail to meet its which sampling has been conducted. Absolute Minimum PFF requirement, Upon receipt of such results, they shall the 5-day count shall begin anew. be subjected to the provisions of para- (vii) When U.S. retention of new lots graphs (b)(2)(i) and (c)(2) of this sec- is discontinued under the above provi- tion. sions, maintenance of the Product (2) The PFF content of three ran- Value shall revert to the provisions of domly selected samples from each U.S. paragraph (b)(2)(ii) of this section. retained lot shall be used to maintain (3) For purposes of this section, the the Product Value described in para- plant owner or operator shall have the graph (c)(2)(ii). The manner and effect option of temporarily removing a prod- of such maintenance shall be as fol- uct from its Product Group, provided lows: (i) Find the average PFF content product lots are being U.S. retained, as of the three samples. produced, and provided further that the (ii) Determine the difference between average production rate of the product, that average and the applicable mini- over the 8-week period preceding the mum PFF percentage requirement of week in which the first U.S. retained § 319.104 or § 319.105. The resulting figure lot was prepared, is not greater than 20 shall be negative when the average of percent of the production rate of its the sample results is less than the ap- Group. When a product is thus removed plicable minimum PFF percentage re- from its Group, analytical results of quirement and shall be positive when product samples shall not cause daily the average of the sample results is sampling of the Group. When pursuant greater than the applicable minimum to paragraph (c)(2)(vi) of this section, PFF requirements. new lots of the product are no longer (iii) Divide the resulting figure by being U.S. retained, the product shall the standard deviation assigned to the again be considered with its Group. product’s Group in paragraph (b)(1)(ii) (d) Adulterated and misbranded prod- of this section, to find the standardized ucts. Products not meeting specified difference. PFF requirements, determined accord- (iv) Use the lesser of 1.30 and the ing to procedures set forth in this sec- standardized difference as the Sample tion, may be deemed adulterated under Value. section 1(m)(8) of the Act (21 U.S.C. (v) Add the first Sample Value thus 601(m)(8)) and misbranded under sec- calculated to the latest Product Value tion 1(n) of the Act (21 U.S.C. 601(n)). calculated under the provisions of (e) Quality control. Cured pork prod- paragraph (c)(2)(ii) of this section to ucts bearing on their labeling the find the new Product Value. To find statement ‘‘X% of Weight is Added In- each succeeding Product Value, add the gredients’’ shall be prepared only under most recent Sample Value to the exist- a total quality control system or paring Product Value; provided, however, tial quality control program in accord- that in no event shall the Product ance with § 318.4 of this subchapter. Value exceed 1.15. When the addition of With respect to any other cured pork a Sample Value to an existing Product product, official establishments may Value results in a figure greater than institute quality control procedures

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under § 318.4 of this subchapter. Cured tations are granted separately for the pork products produced in such estab- food chemistry analysis of official sam- lishments may be exempt from the re- ples and for the analysis of such sam- quirements of this section, provided ples for any one of the several classes inplant quality control procedures are of chemical residue. A laboratory may shown to attain the same or higher de- hold more than one accreditation. gree of compliance as the procedures AOAC methods—Methods of chemical set forth in this section; provided, how- analysis, Chapter 39, Association of Of- ever, that all cured pork products pro- ficial Analytical Chemists (AOAC), duced shall be subject to the applicable published in the ‘‘Official Methods of Absolute Minimum PFF content re- Analysis of the Association of Official quirement, regardless of any quality Analytical Chemists,’’ 15th edition, control procedures in effect. 1990.1 The ‘‘Official Methods of Analy- sis of the Association of Official Ana- [49 FR 14877, Apr. 13, 1984; 49 FR 33434, Aug. lytical Chemists,’’ 15th edition, 1990, is 23, 1984, as amended at 59 FR 33642, June 30, incorporated by reference with the ap- 1994; 60 FR 10304, Feb. 24, 1995] proval of the Director of the Federal § 318.20 Use of animal drugs. Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Animal drug residues are permitted Chemical residue misidentification—see in meat and meat food products if such ‘‘correct chemical residue identifica- residues are from drugs which have tion’’ definition. been approved by the Food and Drug Coefficient of variation (CV)—The Administration and any such drug resi- standard deviation of a distribution of dues are within tolerance levels ap- analytical values multiplied by 100, and proved by the Food and Drug Adminis- divided by the mean of those values. tration, unless otherwise determined Comparison Mean—The average, for a by the Administrator and listed herein. sample, of all accredited and FSIS lab- [50 FR 32165, Aug. 9, 1985] oratories’ average results, each of which has a large deviation measure of § 318.21 Accreditation of chemistry zero, except when only two labora- laboratories. tories perform the analysis, as in the (a) Definitions—Accredited laboratory— case of split sample analysis by both an A non-Federal analytical laboratory accredited laboratory and an FSIS lab- that has met the requirements for ac- oratory. In the latter case, the com- creditation specified in this section parison mean is the average of the two and hence, at an establishment’s dis- laboratories’ results. For food chem- cretion, may be used in lieu of an FSIS istry, a result for a laboratory is the laboratory for analyzing official regu- obtained analytical value; for chemical latory samples. Payment for the analy- residues, a result is the logarithmic sis of official samples is to be made by transformation of the obtained analyt- the establishment using the accredited ical value. laboratory. Correct chemical residue identifica- Accreditation—Determination by tion—Correct identification by a lab- FSIS that a laboratory is qualified to oratory of a chemical residue whose analyze official samples of product sub- concentration, in a sample, is equal to ject to regulations in this subchapter or greater than the minimum reporting and part 381 of this chapter for the level for that residue, as determined by presence and amount of all four food the median of all positive analytical chemistry analytes (protein, moisture, values obtained by laboratories analyz- fat, and salt); or a determination by ing the sample. Failure of a laboratory FSIS that a laboratory is qualified to analyze official samples of product sub- 1 A copy of the ‘‘Official Methods of Analy- ject to regulations in this subchapter sis of the Association of Official Analytical and part 381 of this chapter for the Chemists,’’ 15th edition, 1990, is on file with the Director, Office of the Federal Register, presence and amount of one of several and may be purchased from the Association classes of chemical residue, in accord- of Official Analytical Chemists, Inc., 2200 ance with the requirements of the Ac- Wilson Boulevard, Suite 400, Arlington, Vir- credited Laboratory Program. Accredi- ginia 22201.

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to report the presence such a chemical oratory to assist in determining if ac- residue is considered a misidentifi- ceptable levels of analytical capability cation. In addition, reporting the pres- are being maintained by the accredited ence of a residue at a level equal to or laboratory. above the minimum reporting level Large deviation measure—A measure that is not reported by 90 percent or that quantifies an unacceptably large more of all other laboratories analyz- difference between a non-Federal lab- ing the sample, is considered a oratory’s analytical result and the misidentification. sample comparison mean. CUSUM—A class of statistical proce- Minimum proficiency level—The mini- dures for assessing whether or not a mum concentration of a residue at process is ‘‘in control’’. Each CUSUM which an analytical result will be used value is constructed by accumulating to assess a laboratory’s quantification incremental values obtained from ob- capability. This concentration is an es- served results of the process, and then timate of the smallest concentration determined to either exceed or fall for which the average coefficient of within acceptable limits for that proc- variation (CV) for reproducibility (i.e., ess. The initial CUSUM values for each combined within and between labora- laboratory whose application for ac- tory variability) does not exceed 20 per- creditation is accepted are set at zero. cent. (See Table 2) The four CUSUM procedures are: Minimum reporting level—The number (1) Positive systemic laboratory dif- such that if any obtained analytical ference CUSUM (CUSUM–P)—monitors value equals or exceeds this number, how consistently an accredited labora- then the residue is reported together tory gets numerically greater results with the obtained analytical value. than the comparison mean; (2) Negative systematic laboratory Official Sample—A sample selected by difference CUSUM (CUSUM–N)—mon- a Program employee in accordance itors how consistently an accredited with FSIS procedures for regulatory laboratory gets numerically smaller use. results than the comparison mean; Probation—The period commencing (3) Variability CUSUM (CUSUM–V)— with official notification to an accred- monitors the average ‘‘total discrep- ited laboratory that its check or split ancy’’ (i.e., the combination of the ran- sample results no longer satisfy the dom fluctuations and systematic dif- performance requirements specified in ferences) between an accredited labora- this rule, and ending with official noti- tory’s results and the comparison fication that accreditation is either mean; fully restored, suspended, or revoked. (4) Individual large discrepancy QA (quality assurance) recovery—The CUSUM (CUSUM–D)—monitors the ratio of a laboratory’s unadjusted ana- magnitude and frequency of large dif- lytical value of a check sample residue ferences between the results of an ac- to the residue level fortified by the credited laboratory and the comparison FSIS laboratory that prepared the mean. sample, multiplied by 100. (See Table Individual large deviation—An analyt- 2.) ical result from a non-Federal labora- QC (quality control) recovery—The tory that differs from the sample com- ratio of a laboratory’s unadjusted ana- parison mean by more than would be lytical value of a quality control stand- expected assuming normal laboratory ard to the fortification level of the variability. standard, multiplied by 100. (See Table Initial accreditation check sample—A 2.) sample prepared and sent by an FSIS Refusal of Accreditation—An action laboratory to a non-Federal laboratory taken when a laboratory which is ap- to ascertain if the non-Federal labora- plying for accreditation is denied the tory’s analytical capability meets the accreditation. standards for granting accreditation. Responsibly connected—Any individual Interlaboratory accreditation mainte- who or entity which is a partner, offi- nance check sample—A sample prepared cer, director, manager, or owner of 10 and sent by FSIS to a non-Federal lab- per centum or more of the voting stock

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of the applicant or recipient of accreditation ends when accreditation is ei- tation or an employee in a managerial ther fully restored or revoked. or executive capacity or any employee Systematic laboratory difference—A who conducts or supervises the chemi- comparison of one laboratory’s results cal analysis of FSIS official samples. with the comparison means on samples Revocation of Accreditation—An action that shows, on average, a consistent re- taken against a laboratory which relationship. A laboratory that is report- moves its right to analyze official sam- ing, on average, numerically greater ples. results than the comparison mean has Split sample—An official sample di- a positive systematic laboratory dif- vided into duplicate portions, one por- ference and, conversely, numerically tion to be analyzed by an accredited smaller results indicate a negative sys- laboratory (for official regulatory pur- tematic laboratory difference. poses) and the other portion by an Variability—Random fluctuations in a FSIS laboratory (for comparison pur- laboratory’s processes that cause its poses). analytical results to deviate from a Standardizing Constant—The number true value. which is the result of a mathematical Variance—The expected average of adjustment to the ‘‘standardized the squared differences of sample re- value.’’ Specifically, the number equals sults from an expected sample mean. the square root of the expected variance of the difference between the ac- TABLE 1.ÐSTANDARDIZING VALUES FOR FOOD credited or applying laboratory’s result CHEMISTRY and the comparison mean on a sample, [By product class and analyte] taking into consideration the standard- Product/ izing value, the correlation and number Moisture Protein 1 Fat 2 Salt 3 of repeated results by a laboratory on a Class sample, and the number of laboratories Cured that analyzed the sample. Pork/ Standardized Difference—The quotient Cann- ed of the difference between a laboratory’s Ham .. 0.50 0.060 0.26 (0.30) 0.127 result on a sample and the comparison Ground mean of the sample divided by the Beef .. 0.71 0.060 (0.35) 0.127 standardizing constant. Other .... 0.57 0.060 0.26 (0.30) 0.127 Standardizing Value—A number rep- 1 To obtain the standardizing value for a sample the appro- resenting the performance standard de- priate entry in this column is multiplied by X0.65 where X is the comparison mean of the sample. viation of an individual result (see Ta- 2 To obtain the standardizing value for a sample, the appro- bles 1 and 2 and footnotes to the Tables priate entry in this column is multiplied by X0. 25, where X is the comparison mean of the sample. The appropriate entry is for determining exact procedures for equal to the value in parentheses when X is equal to or great- calculation). er than 12.5 percent, otherwise it is equal to 0.26. 3 To obtain the standardizing value for a sample, when the Suspension of Accreditation—Action comparison mean of the sample, X, is less than 1.0 percent, taken against a laboratory which tem- the standardizing value equals 0.127, otherwise the appropriate entry is multiplied by X0. 25. When X is equal to or porarily removes its right to analyze greater than 4.0 percent for dry salami and pepperoni prod- official samples. Suspension of accredi- ucts, the standardizing value equals 0.22.

TABLE 2.ÐMINIMUM PROFICIENCY LEVELS, PERCENT EXPECTED RECOVERIES (QC AND QA), AND STANDARDIZING VALUES FOR CHEMICAL RESIDUES

Minimum pro- Percent expected Standardizing Class of residues recovery (QC and 3 ficiency level QA) value

Chlorinated Hydrocarbons:1 Aldrin ...... 0.10 ppm 80±110 0.20 Benzene Hexachloride ...... 0.10 ppm 80±110 0.20 Chlordane ...... 0.30 ppm 80±110 0.20 Dieldrin ...... 0.10 ppm 80±110 0.20 DDT ...... 0.15 ppm 80±110 0.20 DDE ...... 0.10 ppm 80±110 0.20 TDE ...... 0.15 ppm 80±110 0.20 Endrin ...... 0.10 ppm 80±110 0.20 Heptachlor ...... 0.10 ppm 80±110 0.20 Heptachlor Epoxide ...... 0.10 ppm 80±110 0.20 Lindane ...... 0.10 ppm 80±110 0.20

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TABLE 2.ÐMINIMUM PROFICIENCY LEVELS, PERCENT EXPECTED RECOVERIES (QC AND QA), AND STANDARDIZING VALUES FOR CHEMICAL RESIDUESÐContinued

Minimum pro- Percent expected Standardizing Class of residues recovery (QC and 3 ficiency level QA) value

Methoxychlor ...... 0.50 ppm 80±110 0.20 Toxaphene ...... 1.00 ppm 80±110 0.20 Hexachlorobenzene ...... 0.10 ppm 80±110 0.20 Mirex ...... 0.10 ppm 80±110 0.20 Nonachlor ...... 0.15 ppm 80±110 0.20 Polychlorinated Biphenyls: 0.50 ppm 80±110 0.20 Arsenic 2 ...... 0.20 ppm 90±105 0.25 Sulfonamides 2 ...... 0.08 ppm 70±120 0.25 Volatile Nitrosamine 2 ...... 5 ppm 70±110 0.25 1 Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical residues. 2 Laboratory statistics are only computed for specific chemical residues. 3 The standardizing value of all initial accreditation and probationary check samples computations is 0.15.

(b) Laboratories accredited for analysis pleted application for the accredita- of protein, moisture, fat, and salt content tion(s) sought by the laboratory. Ac- of meat and meat products— creditation will not be granted or con- (1) Applying for accreditation. Applica- tinued, without further procedure, for tion for accreditation shall be made on failure to pay the accreditation fee(s). designated forms provided by FSIS, or The fee(s) paid shall be nonrefundable otherwise in writing, by the owner or and shall be credited to the account manager of a non-Federal analytical from which the expenses of the labora- laboratory and sent to the Accredited tory accreditation program are paid. Laboratory Program, room 516–A, (iii) Annually on the anniversary Annex Building, Food Safety and In- date of each accreditation, FSIS will spection Service, U.S. Department of issue a bill in the amount specified in Agriculture, 300 12th Street SW., Wash- 9 CFR 391.5. ington, DC 20250–3700, and shall specify (iv) Bills are payable upon receipt by the kinds of accreditation that are check, bank draft, or money order, wanted by the owner or manager of the made payable to the U.S. Department laboratory. A laboratory whose accred- of Agriculture, and become delinquent itation has been refused or revoked 30 days from the date of the bill. Ac- may reapply for accreditation after 60 days from the effective date of that accreditation will be terminated without tion, and must provide written docu- further procedure for having a delin- mentation specifying what corrections quent account. The fee(s) paid shall be were made. nonrefundable and shall be credited to (i) At the time that an Application the account from which the expenses of for Accreditation is filed with the Ac- the Accredited Laboratory Program credited Laboratory Program, FSIS, are paid. and annually thereafter upon receipt of (v) The accreditation of a laboratory the bill issued by FSIS on the anniver- that was accredited by FSIS on or be- sary date of each accreditation, the fore December 13, 1993 and was not on management of a laboratory shall re- probation and whose accreditation on imburse the program at the rate speci- that date was not in suspension or rev- fied in 9 CFR 391.5 for the cost of each ocation shall be continued, provided accreditation that is sought for the that such laboratory reapply for ac- laboratory or that the laboratory creditation in accordance with the pro- holds. visions of this paragraph (b)(1) by Jan- (ii) Simultaneously with the initial uary 12, 1994 (30 days after the effective application for accreditation, the man- date of this section), and that the re- agement of a laboratory shall forward application be accepted by the Agency. a check, bank draft, or money order in The CUSUM values for such laboratory the amount specified in 9 CFR 391.5 will be reset at zero upon acceptance of made payable to the U.S. Department its reapplication. The accreditation of of Agriculture along with the com- a laboratory that is on probation shall

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be continued, provided that the labora- apply after a 60-day waiting period, tory reapply for accreditation by Feb- commencing from the date of refusal of ruary 11, 1994 (60 days after the effec- accreditation by FSIS. At that time, a tive date of this section), that the re- new application, all fees, and all docu- application be accepted by the Agency, mentation of corrective action re- and that the laboratory satisfy the quired for accreditation must be sub- terms of the probation. mitted. (2) Criteria for obtaining accreditation. (A) Systematic laboratory difference: Non-Federal analytical laboratories The absolute value of the average may be accredited for the analyses of standardized difference must not ex- moisture, protein, fat, and salt content ceed 0.73 minus the product of 0.17 and of meat and meat food products. Ac- the standard deviation of the standard- creditation will be given only if the ap- ized differences. plying laboratory successfully satisfies (B) Variability: The estimated stand- the requirements presented below, for ard deviation of the standardized dif- all four analytes. This accreditation ferences must not exceed 1.15. authorizes official FSIS acceptance of (C) Individual large deviations: One the analytical test results provided by hundred times the average of the large these laboratories on official samples. deviation measures of the individual To obtain FSIS accreditation for mois- samples must be less than 5.0.3 ture, protein, fat, and salt analyses, a (iii) Allow inspection of the labora- non-Federal analytical laboratory tory by FSIS officials prior to the de- must: termination of granting accredited sta- (i) Be supervised by a person holding, tus. as a minimum, a bachelor’s degree in (iv) Pay the accreditation fee by the either chemistry, food science, food date required. technology, or a related field and hav- (3) Criteria for maintaining accredita- ing 1 year’s experience in food chem- tion. To maintain accreditation for istry, or equivalent qualifications, as moisture, protein, fat, and salt analy- determined by the Administrator. ses, a non-Federal analytical labora- (ii) Demonstrate acceptable levels of tory must: systematic laboratory difference, vari- (i) Report analytical results of the ability, and individual large deviations moisture, protein, fat, and salt content of official samples, weekly, on des- in the analyses of moisture, protein, ignated forms to the FSIS Eastern fat, and salt content using AOC meth- Laboratory, College Station Road, P.O. ods. An applying laboratory will suc- Box 6085, Athens, GA 30604, or to the cessfully demonstrate these capabili- address designated by the Quality Sys- ties if its moisture, protein, fat, and tems Branch, FSIS Chemistry Division. salt results from a 36 check sample ac- (ii) Maintain laboratory quality con- creditation study each satisfy the cri- trol records for the most recent 3 years teria presented below.2 If the labora- that samples have been analyzed under tory’s analysis of an analyte (or this Program. analytes) from the first set of 36 check (iii) Maintain complete records of the samples does not meet the criteria for receipt, analysis, and disposition of of- obtaining accreditation, a second set of ficial samples for the most recent 3 36 check samples will be provided with- years that samples have been analyzed in 30 days following the date of receipt under this Program. by FSIS of a request from the applying (iv) Maintain a standards book, laboratory. The second set of samples which is a permanently bound book shall be analyzed for only the with sequentially numbered pages, con- analyte(s) for which unacceptable ini- taining all readings and calculations tial results had been obtained by the for standardization of solutions, deter- laboratory. If the results of the second mination of recoveries, and calibration set of samples do not meet the accreditation criteria, the laboratory may re- 3 A result will have a large deviation measure equal to zero when the absolute value of 2 All statistical computations are rounded the result’s standardized difference, (d), is to the nearest tenth, except where otherwise less than 2.5, and otherwise a measure equal noted. to 1–(2.5/d)4.

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of instruments. All entries are to be and salt results from interlaboratory dated and signed by the analyst imme- accreditation maintenance check sam- diately upon completion of the entry ples and/or split samples satisfy the and by his/her supervisor within 2 criteria presented below.5 working days. The standards book is to (A) Systematic laboratory difference: be retained for a period of 3 years after (1) Positive systematic laboratory dif- the last entry is made. ference: The standardized difference be- (v) Analyze interlaboratory accredi- tween the accredited laboratory’s re- tation maintenance check samples and sult and that of the FSIS laboratory return the results to FSIS within 3 for each split or interlaboratory ac- weeks of sample receipt. This must be creditation maintenance check sample done whenever requested by FSIS and is used to determine a CUSUM value, at no cost to FSIS. designated as CUSUM–P. This value is (vi) Inform the Accredited Labora- computed and evaluated as follows: tory Program, room 516–A, Annex (i) Determine the CUSUM increment Building, Food Safety and Inspection for the sample. The CUSUM increment Service, U.S. Department of Agri- is set equal to: culture, 300 12th Street, SW., Washing- 2.0, if the standardized difference is greater ton, DC 20250–3700, by certified or reg- than 1.6, istered mail, within 30 days, when ¥2.0, if the standardized difference is less there is any change in the laboratory’s than ¥1.6, ownership, officers, directors, super- or visory personnel, or other responsibly the standardized difference minus 0.4, if the connected individual or entity. standardized difference lies between ¥1.6 (vii) Permit any duly authorized rep- and 2.4, inclusive. resentative of the Secretary to perform (ii) Compute the new CUSUM–P both announced and unannounced on- value. The new CUSUM–P value is ob- site laboratory reviews of facilities and tained by adding algebraically, the records during normal business hours, CUSUM increment to the last pre- and to copy any records pertaining to viously computed CUSUM–P value. If the laboratory’s participation in the this computation yields a value small- Accredited Laboratory Program. er than 0, the new CUSUM–P value is (viii) Use official AOAC methods 4 on set equal to 0. [CUSUM–P values are official and check samples. The ‘‘Offi- initialized at zero; that is, the CUSUM– cial Methods of Analysis of the Asso- P value associated with the first sam- ciation of Official Analytical Chem- ple is set equal to the CUSUM incre- ists,’’ 15th edition, 1990, is incorporated ment for that sample.] by reference with the approval of the (iii) Evaluate the new CUSUM–P Director of the Federal Register in ac- value. The new CUSUM–P value must cordance with 5 U.S.C. 552(a) and 1 CFR not exceed 5.2. part 51. (2) Negative systematic laboratory dif- (ix) Demonstrate that acceptable ference: The standardized difference be- limits of systematic laboratory dif- tween the accredited laboratory’s reference, variability, and individual sult and that of the FSIS laboratory large deviations are being maintained for each split or interlaboratory ac- in the analyses of moisture, protein, creditation maintenance check sample fat, and salt content. An accredited is used to determine a CUSUM value, laboratory will successfully dem- designated as CUSUM–N. This value is onstrate the maintenance of these ca- computed and evaluated as follows: pabilities if its moisture, protein, fat, (i) Determine the CUSUM increment for the sample. The CUSUM increment 4 A copy of the ‘‘Official Methods of Analy- is set equal to: sis of the Association of Analytical Chem- ists,’’ 15th edition, 1990, is on file with the 2.0, if the standardized difference is greater Director, Office of the Federal Register, and than 1.6, may be purchased from the Association of Official Analytical Chemists, Inc., 2200 Wil- 5 All statistical computations are rounded son Boulevard, Suite 400, Arlington, Virginia to the nearest tenth, except where otherwise 22201. noted.

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¥2.0, if the standardized difference is less CUSUM–D.6 This value is computed and than ¥2.4, evaluated as follows: or (1) Determine the CUSUM increment the standardized difference plus 0.4, if the for the sample. The CUSUM increment standardized difference lies between ¥2.4 and is set equal to the value of the large de- 1.6, inclusive. viation measure minus 0.025. (ii) Compute the new CUSUM–N (2) Compute the new CUSUM–D value. The new CUSUM–N value is ob- value. The new CUSUM–D value is obtained by subtracting, algebraically, tained by adding, algebraically, the the CUSUM increment to the last pre- CUSUM increment to the last previously computed CUSUM–N value. If viously computed CUSUM–D value. If this computation yields a value small- this computation yields a value less er than 0, the new CUSUM–N value is that 0, the new CUSUM–D value is set set equal to 0. [CUSUM–N values are equal to 0. [CUSUM–D values are initialized at zero; that is, the CUSUM– initialized at zero; that is, the CUSUM– N value associated with the first sam- D value associated with the first sample is set equal to the CUSUM incre- ple is set equal to the CUSUM increment for that sample.] ment for that sample.] (iii) Evaluate the new CUSUM–N (3) Evaluate the new CUSUM–D value. The new CUSUM–N value must value. The new CUSUM–D value must not exceed 5.2. not exceed 1.0. (B) Variability: The absolute value of (x) Meet the following requirements the standardized difference between if placed on probation pursuant to the accredited laboratory’s result and paragraph (e) of this section: that of the FSIS laboratory for each (A) Send all official samples that split sample or interlaboratory accred- have not been analyzed as of the date itation maintenance check sample is of written notification of probation to used to determine a CUSUM value, des- a specified FSIS laboratory by certified ignated as CUSUM–V. This value is mail or private carrier or, as an alter- computed and evaluated as follows: native, to an accredited laboratory ap- (1) Determine the CUSUM increment proved for food chemistry. Mailing ex- for the sample. The CUSUM increment penses will be paid by FSIS. is set equal to the larger of 0.4 and ¥ (B) Analyze a set of check samples the absolute value of the standardized similar to those used for initial accred- difference minus 0.9. If this computa- itation, and submit the analytical re- tion yields a value larger than 1.6, the increment is set equal to 1.6. sults to FSIS within 3 weeks of receipt of the samples. (2) Compute the new CUSUM–V value. The new CUSUM–V value is ob- (C) Satisfy criteria for check samples tained by adding, algebraically, the specified in paragraphs (b)(2)(ii) (A), CUSUM increment to the last pre- (B), and (C) of this section. viously computed CUSUM–V value. If (xi) Expeditiously report analytical this computation yields a value less results of official samples to the FSIS than 0, the new CUSUM–V value is set Eastern Laboratory, College Station equal to 0. [CUSUM–V values are Road, P.O. Box 6085, Athens, GA 30604, initialized at zero; that is, the CUSUM– or to the address designated by the V value associated with the first sam- Quality Systems Branch, FSIS Chem- ple is set equal to the CUSUM incre- istry Division. The Federal inspector ment for that sample.] at any establishment may assign the (3) Evaluate the new CUSUM–V analysis of official samples to an FSIS value. The new CUSUM–V value must laboratory if, in the inspector’s judg- not exceed 4.3. ment, there are delays in receiving test (C) Large deviations: The large devi- results on official samples from an ac- ation measure of the accredited labora- credited laboratory. tory’s result for each split sample or (xii) Pay the required accreditation interlaboratory accreditation mainte- fee when it is due. nance check sample is used to determine a CUSUM value, designated as 6 See footnote 3.

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(c) Laboratories accredited for analysis 30 days from the date of the bill. Ac- of a class of chemical residues in meat and creditation will be terminated without meat food products. further procedure for having a delin- (1) Applying for accreditation. Applica- quent account. The fee(s) paid shall be tion for accreditation shall be made on nonrefundable and shall be credited to designated forms provided by FSIS, or the account from which the expenses of otherwise in writing, by the owner or the Accredited Laboratory Program manager of the non-Federal analytical are paid. laboratory and sent to the Accredited (v) The accreditation of a laboratory Laboratory Program, room 516–A, that was accredited by FSIS on or be- Annex Building, Food Safety and In- fore December 13, 1993 and was not on spection Service, U.S. Department of probation and whose accreditation on Agriculture, 300 12th Street, SW., Washington, DC 20250–3700, and shall that date was not in suspension or rev- specify the kinds of accreditation that ocation shall be continued, provided are wanted by the owner or manager of that such laboratory reapply for ac- the laboratory. A laboratory whose accreditation in accordance with the pro- creditation has been refused or revoked visions of this paragraph (c)(1), by Jan- may reapply for accreditation after 60 uary 12, 1994 (30 days of the effective days from the effective date of that ac- date of this section), and that the re- tion, and must provide written docu- application be accepted by the Agency. mentation specifying what corrections The CUSUM values for such laboratory were made. will be reset at zero upon acceptance of (i) At the time that an Application its reapplication. The accreditation of for Accreditation is filed with the Ac- a laboratory that is on probation shall credited Laboratory Program, FSIS, be continued, provided that such lab- and annually thereafter upon receipt of oratory reapply for accreditation by the bill issued by FSIS on the anniver- February 11, 1994 (60 days of the effec- sary date of each accreditation, the tive date of this section), that the re- management of a laboratory shall reapplication be accepted by the Agency, imburse the program at the rate speci- and that the laboratory satisfy the fied in 9 CFR 391.5 for the cost of each terms of the probation. accreditation that is sought for the (2) Criteria for obtaining accreditation. laboratory or that the laboratory Non-Federal analytical laboratories holds. may be accredited for the analysis of a (ii) Simultaneously with the initial application for accreditation, the man- class of chemical residues in meat and agement of a laboratory shall forward meat food products. Accreditation will a check, bank draft, or money order in be given only if the applying labora- the amount specified in 9 CFR 391.5 tory successfully satisfies the require- made payable to the U.S. Department ments presented below. This accredita- of Agriculture along with the com- tion authorizes official FSIS accept- pleted application for the accredita- ance of the analytical test results pro- tion(s) sought for the laboratory. Ac- vided by these laboratories on official creditation will not be granted or con- samples. To obtain FSIS accreditation tinued, without further procedure, for for the analysis of a class of chemical failure to pay the accreditation fee(s). residues, a non-Federal analytical lab- The fee(s) paid shall be nonrefundable oratory must: and shall be credited to the account (i) Be supervised by a person holding, from which the expenses of the labora- as a minimum, a bachelor’s degree in tory accreditation program are paid. either chemistry, food science, food (iii) Annually on the anniversary technology, or a related field. Further, date of each accreditation, FSIS will either the supervisor or the analyst as- issue a bill in the amount specified in signed to analyze the sample must 9 CFR 391.5. have 3 years’ experience determining (iv) Bills are payable upon receipt by analytes at or below part per million check, bank draft, or money order, levels, or equivalent qualifications, as made payable to the U.S. Department of Agriculture, and become delinquent determined by the Administrator.

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(ii) Demonstrate acceptable limits of with the results from the participating systematic laboratory difference, vari- FSIS laboratories. ability, individual large deviations, re- (C) Individual large deviations: One coveries, and proper identification in hundred times the average of the large the analysis of the class of chemical deviation measures of the individual residues for which application was analytical results must be less than made, using FSIS approved procedures. 5.0.8 An applying laboratory will success- (D) QA recovery: The average of the fully demonstrate these capabilities if QA recoveries of the individual analyt- its analytical results for each specific ical results must lie within the range chemical residue provided in a check given in Table 2 under the column enti- sample accreditation study containing tled ‘‘Percent Expected Recovery.’’ a minimum of 14 samples satisfy the (E) QC recovery: All QC recoveries criteria presented in this paragraph must lie within the range given in (c)(2)(ii).7 In addition, if the laboratory Table 2 under ‘‘Percent Expected Re- is requesting accreditation for the covery.’’ Supporting documentation analysis of chlorinated hydrocarbons, must be made available to FSIS upon all analytical results for the residue request. class must collectively satisfy the cri- (F) Correct identification: There must teria. [Conformance to criteria (c)(2)(ii) be correct identification of all chemi- (A), (B), (C), (D), (E), and (F) will only cal residues in all samples. be determined when six or more ana- (iii) Allow inspection of the labora- lytical results with associated com- tory by FSIS officials prior to the de- parison means at or above the loga- termination of granting accredited sta- rithm of the minimum proficiency tus. level are available.] If the results of (iv) Pay the accreditation fee by the the first set of check samples do not date required. meet these criteria for obtaining ac- (3) Criteria for maintaining accredita- creditation, a second set of at least 14 tion. To maintain accreditation for samples will be provided within 30 days analysis of a class of chemical residues, following the date of receipt by FSIS of a non-Federal analytical laboratory a request from the applying laboratory. must: If the results of the second set of sam- (i) [Reserved] ples do not meet accreditation criteria, (ii) Maintain laboratory quality con- the laboratory may reapply after a 60- trol records for the most recent 3 years day waiting period, commencing from that samples have been analyzed under the date of refusal of accreditation by this Program. FSIS. At that time, a new application, (iii) Maintain complete records of the all fees, and all documentation of cor- receipt, analysis, and disposition of of- rective action required for accredita- ficial samples for the most recent 3 tion must be submitted. years that samples have been analyzed (A) Systematic laboratory difference: under the Program. The absolute value of the average (iv) Maintain a standards book, standardized difference must not ex- which is a permanently bound book ceed 1.67 (2.00 if there are less than 12 with sequentially numbered pages, con- analytical results) minus the product taining all readings and calculations of 0.29 and the standard deviation of for standardization of solutions, deter- the standardized differences. mination of recoveries, and calibration (B) Variability: The standard devi- of instruments. All entries are to be ation of the standardized differences dated and signed by the analyst imme- must not exceed a computed limit. diately upon completion of the entry This limit is a function of the number and by his/her supervisor within 2 of analytical results used in the com- working days. The standards book is to putation of the standard deviation, and of the amount of variability associated 8 A result will have a large deviation measure equal to zero when the absolute value of 7 All statistical computations are rounded the result’s standardized difference, (d), is to the nearest tenth, except where otherwise less than 2.5 and otherwise a measure equal noted. 1–(2.5/d)4.

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be retained for a period of 3 years after tween the accredited laboratory’s re- the last entry is made. sult and that of the FSIS laboratory (v) Analyze interlaboratory accredi- for each split and/or interlaboratory tation maintenance check samples and accreditation maintenance check sam- return the results to FSIS within 3 ple is used to determine a CUSUM weeks of sample receipt. This must be value, designated as CUSUM–P.11 This done whenever requested by FSIS and value is computed and evaluated as fol- at no cost to FSIS. lows: (vi) Inform the Accredited Labora- (i) Determine the CUSUM increment tory Program, room 516–A, Annex for the sample. The CUSUM increment Building, Food Safety and Inspection is set equal to: Service, U.S. Department of Agri- culture, 300 12th Street, SW., Washing- 2.0, if the standardized difference is greater ton, DC 20250–3700, by certified or reg- than 2.5, istered mail, within 30 days of any ¥2.0, if the standardized difference is less change in the laboratory’s ownership, than ¥1.5, officers, directors, supervisory person- or nel, or any other responsibly connected the standardized difference minus 0.5, if the individual or entity. standardized difference lies between ¥1.5 (vii) Permit any duly authorized rep- and 2.5, inclusive. resentative of the Secretary to perform both announced and unannounced on- (ii) Compute the new CUSUM–P site laboratory reviews of facilities and value. The new CUSUM–P value is ob- records during normal business hours, tained by adding, algebraically, the and to copy any records pertaining to CUSUM increment to the last pre- the laboratory’s participation in the viously computed CUSUM–P value. If Accredited Laboratory Program. this computation yields a value small- (viii) Use analytical procedures des- er than 0, the new CUSUM–P value is ignated and approved by FSIS. set equal to 0. [CUSUM–P values are (ix) Demonstrate that acceptable initialized at zero; that is, the CUSUM– limits of systematic laboratory dif- P value associated with the first sam- ference, variability, and individual ple is set equal to the CUSUM incre- large deviations are being maintained ment for that sample.] in the analysis of samples, in the chem- (iii) Evaluate the new CUSUM–P ical residue class for which accredita- value. The new CUSUM–P value must tion was granted. A laboratory will not exceed 4.8. successfully demonstrate the mainte- (2) Negative systematic laboratory dif- nance of these capabilities if its ana- ference: The standardized difference be- lytical results for each specific chemi- tween the accredited laboratory’s re- cal residue found in interlaboratory ac- sult and that of the FSIS laboratory creditation maintenance check sam- for each split and/or interlaboratory ples and/or split samples satisfy the accreditation maintenance check sam- criteria presented in this paragraph ple is used to determine a CUSUM (c)(3)(ix).9, 10 In addition, if the labora- 12 tory is accredited for the analysis of value, designated as CUSUM–N. This chlorinated hydrocarbons, all analytical results for the residue class must 11 When determining compliance with this collectively satisfy the criteria. criterion for all chlorinated hydrocarbon re- (A) Systematic laboratory difference: sults in a sample collectively, the following statistical procedure must be followed to ac- (1) Positive systematic laboratory dif- count for the correlation of analytical reference: The standardized difference be- sults within a sample: the average of the standardized differences of the analytical re- 9 All statistical computations are rounded sults within the sample, divided by a con- to the nearest tenth, except where otherwise stant, is used in place of a single standard- noted. ized difference to determine the CUSUM–P 10 An analytical result will only be used in (or CUSUM–N) value for the sample. The the statistical evaluation of the laboratory if constant is a function of the number of ana- the associated comparison mean is equal to lytical results used to compute the average or greater than the logarithm of the mini- standardized difference. mum proficiency level for the residue. 12 See footnote 11.

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value is computed and evaluated as fol- (2) Compute the new CUSUM–V lows: value. The new CUSUM–V value is ob- (i) Determine the CUSUM increment tained by adding, algebraically, the for the sample. The CUSUM increment CUSUM increment to the last pre- is set equal to: viously computed CUSUM–V value. If this computation yields a value less 2.0, if the standardized difference is greater than 0, the new CUSUM–V value is set than 1.5, equal to 0. [CUSUM–V values are 2.0, if the standardized difference is less ¥ initialized at zero; that is, the CUSUM– than ¥2.5, V value associated with the first sam- or ple is set equal to the CUSUM incre- the standardized difference plus 0.5, if the ment for that sample.] standardized difference lies between ¥2.5 (3) Evaluate the new CUSUM–V and 1.5, inclusive. value. The new CUSUM–V value must (ii) Compute the new CUSUM–N not exceed 4.3. value. The new CUSUM–N value is ob- (C) Large Deviations: The large devi- tained by subtracting, algebraically, ation measure of the accredited labora- the CUSUM increment to the last pre- tory’s result for each split and/or inter- viously computed CUSUM–N value. If laboratory accreditation maintenance this computation yields a value small- check sample is used to determine a er than 0, the new CUSUM–N value is CUSUM value, designated as CUSUM– set equal to 0. [CUSUM–N values are D.14 This value is computed and evalu- initialized at zero; that is, the CUSUM– ated as follows: N value associated with the first sam- (1) Determine the CUSUM increment ple is set equal to the CUSUM incre- for the sample. The CUSUM increment ment for that sample.] is set equal to the large deviation (iii) Evaluate the new CUSUM–N measure minus 0.025. value. The new CUSUM–N value must (2) Compute the new CUSUM–D not exceed 4.8. value. The new CUSUM–D is obtained (B) Variability: The absolute value of by adding, algebraically, the CUSUM the standardized difference between increment to the last previously computed CUSUM–D value. If this com- the accredited laboratory’s result and putation yields a value less than 0, the that of the FSIS laboratory for each new CUSUM–D value is set equal to 0. split and/or interlaboratory accredita- [CUSUM–D values are initialized at tion maintenance check sample is used zero; that is, the CUSUM–D value asso- to determine a CUSUM value, des- ciated with the first sample is set equal ignated as CUSUM–V.13 This value is to the CUSUM increment for that sam- computed and evaluated as follows: ple.] (1) Determine the CUSUM increment (3) Evaluate the new CUSUM–D for the sample. The CUSUM increment value. The new CUSUM–D value must is set equal to the larger of ¥0.4 and not exceed 1.0. the absolute value of the standardized (x) Meet the following requirements difference minus 0.9. If this computa- if placed on probation pursuant to tion yields a value larger than 1.6, the paragraph (e) of this section: increment is set equal to 1.6. (A) Send all official samples that have not been analyzed as of the date 13 When determining compliance with this of written notification of probation to criterion for all chlorinated hydrocarbon re- a specified FSIS laboratory by certified sults in a sample collectively, the following mail or private carrier or, as an alter- statistical procedure must be followed to ac- native, to an accredited laboratory account for the correlation of analytical re- credited for this specific chemical resi- sults within a sample: the square root of the due. Mailing expense will be paid by sum of the within sample variance and the average standardized difference of the sam- FSIS. ple, divided by a constant, is used in place of the absolute value of the standardized dif- 14 A result will have a large deviation ference to determine the CUSUM–V value for measure equal to zero when the absolute the sample. The constant is a function of the value of the result’s standardized difference, number of analytical results used to com- (d), is less than 2.5, and otherwise a measure pute the average standardized difference. equal to 1¥(2.5/d)4.

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(B) Analyze a set of check samples CUSUM–P.15 This value is computed similar to those used for initial accred- and evaluated as follows: itation, and submit analytical results (i) Determine the CUSUM increment to FSIS within 3 weeks of receipt of for the sample. The CUSUM increment the samples. is set equal to: (C) Satisfy criteria for check samples 2.0, if the standardized difference is greater as specified in paragraphs (c)(2)(ii) (A), than 2.5, (B), (C), (D), (E), and (F) of this section. ¥2.0, if the standardized difference is less (xi) Expeditiously report analytical than ¥1.5, results of official samples to the East- or ern Laboratory, College Station Road, the standardized difference minus 0.5, if the P.O. Box 6085, Athens, GA 30604, or to standardized difference lies between ¥1.5 and 2.5, inclusive. the address designated by the Quality Systems Branch, FSIS Chemistry Divi- (ii) Compute the new CUSUM–P sion. The Federal inspector at any es- value. The new CUSUM–P value is ob- tablishment may assign the analysis of tained by adding, algebraically, the official samples to an FSIS laboratory CUSUM increment to the last pre- if, in the judgment of the inspector, viously computed CUSUM–P value. If there are delays in receiving test re- this computation yields a value small- sults on official samples from an ac- er than 0, the new CUSUM–P value is set equal to 0. [CUSUM–P values are credited laboratory. initialized at zero; that is, the CUSUM– (xii) Every QC recovery associated P value associated with the first sam- with reporting of official samples must ple is set equal to the CUSUM incre- be within the appropriate range given ment for that sample.] in Table 2 under ‘‘Percent Expected Re- (iii) Evaluate the new CUSUM–P covery.’’ Supporting documentation value. The new CUSUM–P value must must be made available to FSIS upon not exceed 4.8. request. (2) Negative systematic laboratory dif- (xiii) Demonstrate that acceptable ference: The standardized difference be- levels of systematic laboratory dif- tween the accredited laboratory’s reference, variability, individual large sult and the comparison mean for each deviations, recoveries, and proper iden- interlaboratory accreditation mainte- tification are being maintained in the nance check sample is used to deter- analysis of interlaboratory accredita- mine a CUSUM value, designated as tion maintenance check samples, in CUSUM–N.16 This value is computed the chemical residue class for which and evaluated as follows: accreditation was granted. A labora- (i) Determine the CUSUM increment tory will successfully demonstrate the for the sample. The CUSUM increment maintenance of these capabilities if its is set equal to: analytical results for each specific 2.0, if the standardized difference is greater chemical residue found in interlabora- than 1.5, tory accreditation maintenance check ¥2.0, if the standardized difference is less than 2.5, samples satisfy the criteria presented ¥ below. In addition, if the laboratory is or accredited for the analysis of the standardized difference plus 0.5, if the standardized difference lies between ¥2.5 and chlorinated hydrocarbons, all analyt- 1.5, inclusive. ical results for the residue class must collectively satisfy the criteria. (ii) Compute the new CUSUM–N (A) Systematic laboratory difference— value. The new CUSUM–N value is obtained by subtracting, algebraically, (1) Positive systematic laboratory dif- the CUSUM increment to the last pre- ference: The standardized difference be- viously computed CUSUM–N value. If tween the accredited laboratory’s re- this computation yields a value small- sult and the comparison mean for each er than 0, the new CUSUM–N value is interlaboratory accreditation maintenance check sample is used to deter- 15 See footnote 11. mine a CUSUM value, designated as 16 See footnote 11.

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set equal to 0. [CUSUM–N values are by adding, algebraically, the CUSUM initialized at zero; that is, the CUSUM– increment to the last previously com- N value associated with the first sam- puted CUSUM–D value. If this comple is set equal to the CUSUM incre- putation yields a value less than 0, the ment for that sample.] new CUSUM–D value is set equal to 0. (iii) Evaluate the new CUSUM–N [CUSUM–D values are initialized at value. The new CUSUM–N value must zero; that is, the CUSUM–D value asso- not exceed 4.8. ciated with the first sample is set equal (B) Variability: The absolute value of to the CUSUM increment for that sam- the standardized difference between ple.] the accredited laboratory’s result and (3) Evaluate the new CUSUM–D the comparison mean for each interlab- value. The new CUSUM–D value must oratory accreditation maintenance not exceed 1.0. check sample is used to determine a (D) Each QC Recovery is within the CUSUM value, designated as CUSUM– range given in Table 2 under ‘‘Percent 17 V. This value is computed and evalu- Expected Recovery’’. Supporting docu- ated as follows: mentation must be made available to (1) Determine the CUSUM increment FSIS upon request. for the sample. The CUSUM increment (E) Not more than 1 residue is set equal to the larger of ¥0.4 or the misidentification in any 2 consecutive absolute value of the standardized difference minus 0.9. If this computation check samples. yields a value larger than 1.6, the in- (F) Not more than 2 residue crement is set equal to 1.6. misidentifications in any 8 consecutive (2) Compute the new CUSUM–V check samples. value. The new CUSUM–V value is ob- (xiv) Pay the accreditation fee when tained by adding, algebraically, the it is due. CUSUM increment to the last pre- (d) Refusal of accreditation. Upon a de- viously computed CUSUM–V value. If termination by the Administrator, a this computation yields a value less laboratory shall be refused accredita- than 0, the new CUSUM–V value is set tion for the following reasons: equal to 0. [CUSUM–V values are (1) A laboratory shall be refused ac- initialized at zero; that is, the CUSUM– creditation for moisture, protein, fat, V value associated with the first sam- and salt analysis for failure to meet ple is set equal to the CUSUM incre- the requirements of paragraph (b)(1) or ment for that sample.] (b)(2) of this section. (3) Evaluate the new CUSUM–V (2) A laboratory shall be refused ac- value. The new CUSUM–V value must creditation for chemical residue analy- not exceed 4.3. sis for failure to meet the requirements (C) Large deviations: The large devi- of paragraph (c)(1) or (c)(2) of this sec- ation measure of the accredited labora- tion. tory’s result for each interlaboratory (3) A laboratory shall be refused sub- accreditation maintenance check sam- sequent accreditation for failure to re- ple is used to determine a CUSUM turn to an FSIS laboratory, by cer- 18 value, designated as CUSUM–D. This tified mail or private carrier, all offi- value is computed and evaluated as fol- cial samples which have not been ana- lows: lyzed as of the notification of a loss of (1) Determine the CUSUM increment accreditation. for the sample. The CUSUM increment (4) A laboratory shall be refused ac- is set equal to the value of the large de- creditation if the applicant or any indi- viation measure minus 0.025. vidual or entity responsibly connected (2) Compute the new CUSUM–D with the applicant has been convicted value. The new CUSUM–D is obtained of or is under indictment or if charges on an information have been brought 17 See footnote 13. against the applicant or responsibly 18 A result will have a large deviation connected individual or entity in any measure equal to zero when the absolute value of the result’s standardized difference, Federal or State court concerning the (d), is less than 2.5, and otherwise a measure following violations of law: equal to 1¥(2.5/d)4. (i) Any felony.

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(ii) Any misdemeanor based upon ac- criteria for reporting the analytical requiring, handling, or distributing of sults on interlaboratory accreditation unwholesome, misbranded, or decep- maintenance check samples as set tively packaged food or upon fraud in forth in paragraph (b)(3)(v) of this sec- connection with transactions in food. tion or if, at any time, the CUSUM re- (iii) Any misdemeanor based upon a sults from the analysis of such inter- false statement to any governmental laboratory accreditation maintenance agency. check samples and/or split samples (iv) Any misdemeanor based upon the have not satisfied the criteria specified offering, giving or receiving of a bribe in paragraph (b)(3)(ix) of this section or unlawful gratuity. and there have been, during the pre- (e) Probation of accreditation. Upon a vious 12 months, no other occasions on determination by the Administrator, a which such CUSUM results have not laboratory shall be placed on probation satisfied such criteria, the laboratory for the following reasons: shall be placed on probation; but if (1) If the laboratory fails to complete there have been such other occasions more than one interlaboratory accredi- during those 12 months, the labora- tation maintenance check sample anal- tory’s accreditation will be revoked. ysis within 12 consecutive months as (2) An accredited laboratory which is required by paragraphs (b)(3)(v) and accredited to perform analysis for a (c)(3)(v) of this section. class of chemical residues under para- (2) If the laboratory fails to meet any graph (c) of this section shall have the of the criteria set forth in paragraphs accreditation to perform this analysis (b)(3)(v) and ((b)(3)(ix) and (c)(3)(v) and revoked if it fails to meet any of the (c)(3)(ix) of this section. requirements in paragraph (c)(3) of this (f) Suspension of accreditation. The ac- section except for the following cir- creditation of a laboratory shall be sus- cumstances. If the accredited labora- pended if the laboratory or any individ- tory fails to meet any of the criteria ual or entity responsibly connected set forth in paragraphs (c)(3)(v), with the laboratory is indicted or if (c)(3)(ix), and (c)(3)(xiii) of this section charges on an information have been and it has not so failed during the 12 brought against the laboratory or re- months preceding its failure to meet sponsibly connected individual or en- the criteria, it shall be placed on pro- tity in any Federal or State court con- bation, but if it has so failed at any cerning any of the following violations time during those 12 months, its ac- of law: creditation will be revoked. (1) Any felony. (3) An accredited laboratory shall (2) Any misdemeanor based upon ac- have its accreditation revoked if the quiring, handling or distributing of un- Administrator determines that the lab- wholesome, misbranded, or deceptively oratory or any responsibly connected packaged food or upon fraud in connec- individual or any agent or employee tion with transactions in food. has: (3) Any misdemeanor based upon a (i) Altered any official sample or ana- false statement to any governmental lytical finding, or, agency. (ii) Substituted any analytical result (4) Any misdemeanor based upon the from any other laboratory for its own. offering, giving or receiving of a bribe (4) An accredited laboratory shall or unlawful gratuity. have its accreditation revoked if the (g) Revocation of accreditation. The ac- laboratory or any individual or entity creditation of a laboratory shall be re- responsibly connected with the labora- voked for the following reasons: tory is convicted in a Federal or State (1) An accredited laboratory which is court of any of the following violations accredited to perform analysis under of law: paragraph (b) of this section shall have (i) Any felony. its accreditation revoked for failure to (ii) Any misdemeanor based upon ac- meet any of the requirements of para- quiring, handling, or distributing of graph (b)(3) of this section except for unwholesome, misbranded, or decep- the following circumstances. If the actively packaged food or upon fraud in credited laboratory fails to meet the connection with transactions in food.

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(iii) Any misdemeanor based upon a dressing; meat byproducts; mechani- false statement to any governmental cally separated (species); and poultry agency. products; except those ingredients (iv) Any misdemeanor based upon the processed by hydrolysis, extraction, offering, giving or receiving of a bribe concentrating or drying. or unlawful gratuity. (3) Group 2 Protein-Contributing Ingre- (h) Notification and hearings. Accredi- dients. Ingredients from Gorup 1 pro- tation of any laboratory shall be re- tein-contributing ingredients processed fused, suspended, or revoked under the by hydrolysis, extraction, concentrat- conditions previously described herein. ing, or drying, or any other ingredient The owner or operator of the labora- which contributes protein. tory shall be sent written notice of the (b) The amount of added water in refusal, suspension, or revocation of ac- cooked sausage is calculated by: creditation by the Administrator. In (1) Determining by laboratory analy- such cases, the laboratory owner or op- sis the total percentage of water con- erator will be provided an opportunity tained in the cooked sausage; and to present, within 30 days of the date of the notification, a statement challeng- (2) Determining by laboratory analy- ing the merits or validity of such ac- sis the total percentage of protein con- tion and to request an oral hearing tained in the cooked sausage; and with respect to the denial, suspension, (3) Calculating the percentage of pro- or revocation decision. An oral hearing tein in the cooked sausage contributed shall be granted if there is any dispute by the Group 2 protein-contributing in- of material fact joined in such respon- gredients; and sive statement. The proceeding shall (4) Subtracting one pecent from the thereafter be conducted in accordance total percentage of protein calculated with the applicable rules of practice in (b)(3)); and which shall be adopted for the proceed- (5) Subtracting the remaining per- ing. Any such refusal, suspension, or centage of protein calculated in (b)(3) revocation shall be effective upon the from the total protein content deter- receipt by the laboratory of the notifi- mined in (b)(2); and cation and shall continue in effect (6) Calculating the percentage of in- until final determination of the matter digenous water in the cooked sausage by the Administrator. by multiplying the percentage of pro- (Reporting and recordkeeping requirements tein determined in (b)(5) by 4, (This approved by the Office of Management and amount is the percentage of water at- Budget under control number 0583–0015) tributable to Group 1 protein-contrib- [52 FR 2185, Jan. 20, 1987, as amended at 58 uting ingredients and one percent of FR 65260, 65262–65264, Dec. 13, 1993; 59 FR Group 2 protein-contributing ingredi- 33642, June 30, 1994; 59 FR 66448, Dec. 27, 1994; ents in a cooked sausage.); and 60 FR 10305, Feb. 24, 1995] (7) Subtracting the percentage of water calculated in (b)(6) from the § 318.22 Determination of added water total percentage of water determined in cooked sausages. in (b)(1). (This amount is the percent- (a) For purposes of this section, the age of added water in a cooked sau- following definitions apply. sage.) 1 (1) Cooked sausage. Cooked sausage is any product described in § 319.140 and [55 FR 7299, Mar. 1, 1990] §§ 319.180–319.182 of this chapter. (2) Group 1 Protein-Contributing Ingre- 1 The equation for the narrative description dients. Ingredients of livestock or poul- of the calculation for added water is as fol- try origin from muscle tissue which is lows: AW=TW-(TP-(P-1.0))4, Where skeletal or which is found in the edible AW=Added Water, TW-Total Water Deter- organs, with or without the accom- mined by Laboratory Analysis, TP=Total panying and overlying fat, and the por- Protein Determined by Laboratory Analysis, P=Protein Contributed by Group 2 Protein- tions of bone, skin, sinew, nerve, and Contributing Ingredients, 1.0=Percent Allow- blood vessels which normally accom- ance for Group 2 Protein-Contributing Ingre- pany the muscle tissue and which are dients, 4=Moisture-Protein Ratio for Cooked not separated from it in the process of Sausage.

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§ 318.23 Heat-processing procedures, patty, but not above 70 °F, when the cooking instructions, and cooling, char-marks are applied to the patty. handling, and storage requirements The process of char-marking the patty for uncured meat patties. and cooling the patty to a maximum (a) Definitions. For purposes of this internal temperature of 40 °F shall be section, the following definitions shall completed within 2 hours or less. apply: (iv) The official establishment shall (1) Comminuted. A processing term de- measure the holding time and tempera- scribing the reduction in size of pieces ture of at least one heat-processed of meat, including chopping, flaking, patty from each production line each grinding, or mincing, but not including hour of production to assure control of chunking or sectioning. the heat process. The temperature (2) Heat-processed. Treatment by a measuring device shall be accurate heat source, including, but not limited within 1 °F. to, frying, broiling, baking, or roast- (2) Cooling. (i) Fully-cooked patties ing, which results in a fully-cooked, partially-cooked, or char-marked prod- shall be cooled to an internal tempera- ° uct. ture of 40 F or below within 2 hours (3) Patty. A shaped and formed, after heat-processing. comminuted, flattened cake of meat (ii) Cooling requirements for par- food product. tially-cooked and char-marked patties (b) Processing procedures for heat-proc- are combined with those for heat-processed patties. Fully-cooked, partially- essing and are contained in paragraph cooked, or char-marked patties shall (b)(1)(ii) and (iii) of this section. be processed as follows: (iii) The internal temperature meas- (1) Heat processing. (i) Official estab- uring device shall be accurate within 1 lishments which manufacture fully- °F. cooked patties shall utilize one of the (3) Cooking instruction label require- heat-processing procedures in Table A ment. (i) Partially-cooked patties shall of this paragraph: bear the labeling statement ‘‘Partially- cooked: For Safety Cook Until Well TABLE A.ÐPERMITTED HEAT-PROCESSING TEM- Done (Internal Meat Temperature 160 PERATURE/TIME COMBINATIONS FOR FULLY- °F)’’. The labeling statement shall be COOKED PATTIES adjacent to the product name, at least Minimum internal temperature at the Minimum holding one-half the size of the largest letter in center of each patty time after maximum temperature the product name, and prominently Degrees is reached placed with such conspicuousness (as Time compared with other words, statements, designs or devices in the label- Fahrenheit or Centigrade (Min- or (Sec- utes) onds) ing) as to render it likely to be read and understood by the ordinary indi- 151 ...... 66.1 ...... 0.68 41 152 ...... 66.7 ...... 54 32 vidual under customary conditions of 153 ...... 67.2 ...... 43 26 purchase and use. 154 ...... 67.8 ...... 34 20 (ii) Char-marked patties. Product 155 ...... 68.3 ...... 27 16 156 ...... 68.9 ...... 22 13 shall bear the labeling statement 157 (and up) ...... 69.4 (and up) ...... 17 10 ‘‘Uncooked, Char-marked: For Safety, Cook Until Well Done (Internal Meat (ii) Official establishments which Temperature 160 °F)’’. The labeling manufacture partially-cooked patties statement shall be adjacent to the shall raise the internal temperature at product name, at least one-half the size the center of each patty to a minimum of the largest letter in the product internal temperature of 140 °F. and name, and prominently placed with then cool it to a maximum internal such conspicuousness (as compared temperature of 40 °F within 2 hours. with other words, statements, designs (iii) Official establishments which or devices in the labeling) as to render manufacture char-marked patties (if it likely to be read and understood by marked by a heat source) may raise the the ordinary individual under cus- temperature at the center of each tomary conditions of purchase and use.

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(4) Sanitary handling and storage prac- (iv) Fully-cooked, partially-cooked, tices. Fully-cooked patties shall be han- and char-marked patties shall be dled in accordance with the following stored at a chamber temperature of 40 provisions so as to assure that the pat- °F or below. ties are not recontaminated. (c) Requirements for handling heating (i) To prevent direct contamination or cooling deviations. (1) If for any rea- of fully-cooked patties, official estab- son a heating or cooling deviation has lishments shall: occurred, the official establishment (A) Physically separate areas where shall investigate and identify the unpackaged, fully-cooked patties are cause; take steps to assure that the de- handled from areas where less-than- viation will not recur; and place on file fully-cooked products are handled in the official establishment, available using a solid impervious floor to ceil- to any duly authorized representative ing wall; or of the Secretary, a report of the inves- (B) Handle unpackaged, fully-cooked tigation, the cause of the deviation, patties and less-than-fully-cooked and the steps taken to prevent recur- product at different times, and clean- rence; and ing the entire area after handling other (2) In addition, in the case of a heat- products before handling unpackaged, ing deviation, the official establish- fully-cooked patties; or ment may (i) reprocess the affected (C) Submit a written procedure product, by a method in paragraph through the inspector-in-charge to the (b)(1)(i) in this section, or (ii) use the Regional Director detailing the steps affected product as an ingredient in an- to be taken which would avoid re- other product processed to one of the contamination of fully-cooked patties temperature and time combinations in by less-than-fully-cooked cooked prod- paragraph (b)(1)(i) in this section, pro- uct during processing. vided this does not violate the final (ii) To prevent indirect contamina- product’s standard of composition, tion of fully-cooked patties: upset the order of predominance of in- (A) Any work surface, machine, or gredients, or perceptibly affect the nor- tool which contacts other product shall mal product characteristics, or (iii) be cleaned and sanitized before it con- relabel the affected product as a par- tacts unpackaged fully-cooked patties. tially-cooked patty product, if it meets The sanitizer shall be germicidally the partially-cooked requirements in equivalent to 50 ppm chlorine. paragraph (b)(1)(ii) of this section. (B) Employees shall wash their hands (3) In addition, in the case of a cool- with soap and water and sanitize their ing deviation, contact the Regional Di- hands whenever they enter the fully- rector to determine the disposition of cooked patty area or before handling the product. unpackaged, fully-cooked patties. They [58 FR 41151, Aug. 2, 1993] must also wash and sanitize their hands whenever they become contami- § 318.24 Compliance procedures for nated during operations to avoid con- meat derived from advanced meat/ tamination of fully-cooked patties. The bone separation machinery and re- sanitizer shall be germicidally equiva- covery systems. lent to 50 ppm chlorine. (a) The product resulting from the (C) All employee outer garments, in- separating process shall not have a cal- cluding aprons, smocks, and gloves cium content exceeding 0.15 percent or shall be identified as restricted for use 150 mg/100 gm of product within a toler- in the fully-cooked area only. The em- ance of 0.03 percent or 30 mg, as pre- ployee shall change garments at least scribed in § 301.2(rr)(2) of this sub- daily. The garments shall be hung in a chapter. designated location before the em- (b) To verify the calcium content in ployee leaves the area. meat derived from advanced meat/bone (iii) Fully-cooked patties stored in separation machinery and recovery the same room with other product, systems, a compliance program con- shall first be packaged or covered to sisting of the following parameters prevent microbial contamination. shall be followed by manufacturers of

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meat defined in § 301.2(rr)(2) of this sub- quirements for MS(S) in § 319.5 of this chapter. subchapter. (1) An analysis of a sample of at least (2) The management of the establish- 1 pound from each lot shall be per- ment must maintain records to support formed by the operator of the estab- the validity of the calcium content (as lishment or his or her agent. For pur- a measure of bone solids) to assure the poses of this paragraph, a lot shall con- process is in control. Such records sist of the meat derived from advanced shall be made available to the inspec- meat/bone separation machinery and tor or any other duly authorized rep- recovery systems, designated as such resentative of the Agency upon re- by the operator of the establishment or quest. (Recordkeeping requirements his or her agent, from the product pro- were approved by the Office of Manage- duced from a single species of livestock ment and Budget under control number in no more than one continuous shift of 0583–0095.) up to 12 hours. Individual results from [59 FR 62561, Dec. 6, 1994] the chemical analyses shall be compared to the calcium limit, prescribed Subparts B—F [Reserved] in paragraph (a) of this section, in order to demonstrate compliance. If compliance is not demonstrated, that Subpart G—Canning and Canned is, if any single analytical result is Products more than 0.18 percent,1 2 before product from a production lot that is still SOURCE: 51 FR 45619, Dec. 19, 1986, unless otherwise noted. at the establishment or one that is subsequently produced can be considered to be in compliance, at least three sam- § 318.300 Definitions. ples from that production lot shall be (a) Abnormal container. A container taken and analyzed for calcium, either with any sign of swelling or product separately, or, at the option of the es- leakage or any evidence that the con- tablishment, as a composite (i.e., com- tents of the unopened container may be bining the three samples for analysis). spoiled. The average of the results or the com- (b) Acidified low acid product. A posite result must be less than or equal canned product which has been formu- to 0.15 percent. Taking three samples lated or treated so that every compo- from each subsequently produced lot nent of the finished product has a pH of and analyzing them in order to dem- 4.6 or lower within 24 hours after the onstrate compliance shall continue completion of the thermal process un- until five consecutive lots have mean less data are available from the estab- or composite results less than or equal lishment’s processing authority dem- to 0.15 percent. If the statistical evi- onstrating that a longer time period is dence indicates that a production lot is safe. not in compliance with the calcium (c) Bleeders. Small orifices on a retort limit, as prescribed in § 301.2(rr)(2) of through which steam, other gasses, and this subchapter, the lot must be la- condensate are emitted from the retort beled as MS(S) and meet all of the re- throughout the entire thermal process. (d) Canned product. A meat food product with a water activity above 0.85 1 The value 0.18 percent was derived by multiplying by 3 the expected analytical which receives a thermal process either standard deviation obtained by FSIS labora- before or after being packed in a her- tories on the approved chemical procedure metically sealed container. Unless oth- for measuring calcium which uses erwise specified, the term ‘‘product’’ as Ethylenediaminetetraacetic acid (EDTA) as used in this Subpart G shall mean provided in the ‘‘Official Methods of Analysis ‘‘canned product.’’ of the AOAC International’’ (formerly the (e) Closure technician. The individ- Association of Official Analytical Chemists), 15th Ed. (1990). ual(s) identified by the establishment 2 Individual or an average of results shall as being trained to perform specific be rounded to the nearest 0.01 percent cal- container integrity examinations as re- cium. quired by this subpart and designated

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by the establishment to perform such kept at a specific temperature for a examinations. specified period of time in order to de- (f) Code lot. All production of a par- termine if outgrowth of microorga- ticular product in a specific size con- nisms occurs. tainer marked with a specific con- (l) Initial temperature. The tempera- tainer code. ture, determined at the initiation of a (g) Come-up time. The elapsed time, thermal process cycle, of the contents including venting time (if applicable), of the coldest container to be proc- between the introduction of the heat- essed. ing medium into a closed retort and (m) Low acid product. A canned prod- the start of process timing. uct in which any component has a pH (h) Critical factor. Any characteristic, value above 4.6. condition or aspect of a product, con- (n) Process schedule. The thermal tainer, or procedure that affects the process and any specified critical fac- adequacy of the process schedule. Criti- tors for a given canned product re- cal factors are established by process- quired to achieve shelf stability. ing authorities. (o) Process temperature. The minimum (i) Headspace. That portion of a con- temperature(s) of the heating medium tainer not occupied by the product. to be maintained as specified in the (1) Gross headspace. The vertical dis- process schedule. tance between the level of the product (p) Process time. The intended time(s) (generally the liquid surface) in an up- a container is to be exposed to the right rigid container and the top edge heating medium while the heating me- of the container (i.e., the flange of an dium is at or above the process tem- unsealed can, the top of the double perature(s). seam on a sealed can, or the top edge of (q) Processing authority. The person(s) an unsealed jar). or organization(s) having expert knowl- (2) Net headspace. The vertical dis- edge of thermal processing require- tance between the level of the product ments for foods in hermetically sealed (generally the liquid surface) in an up- containers, having access to facilities right rigid container and the inside for making such determinations, and surface of the lid. designated by the establishment to per- (j) Hermetically sealed containers. Air- form certain functions as indicated in tight containers which are designed this subpart. and intended to protect the contents (r) Program employee. Any inspector against the entry of microorganisms or other individual employed by the during and after thermal processing. Department or any cooperating agency (1) Rigid container. A container, the who is authorized by the Secretary to shape or contour of which, when filled do any work or perform any duty in and sealed, is neither affected by the connection with the Program (see enclosed product nor deformed by ex- § 301.2(f)). ternal mechanical pressure of up to 10 (s) Retort. A pressure vessel designed pounds per square inch gauge (0.7 kg/ for thermal processing of product cm2) (i.e., normal firm finger pressure). packed in hermetically sealed contain- (2) Semirigid container. A container, ers. the shape or contour of which, when (t) Seals. Those parts of a semirigid filled and sealed, is not significantly container and lid or of a flexible con- affected by the enclosed product under tainer that are fused together in order normal atmospheric temperature and to hermetically close the container. pressure, but can be deformed by exter- (u) Shelf stability. The condition nal mechanical pressure of less than 10 achieved by application of heat, suffi- pounds per square inch gauge (0.7 kg/ cient, alone or in combination with cm2) (i.e., normal firm finger pressure). other ingredients and/or treatments, to (3) Flexible container. A container, the render the product free of microorga- shape or contour of which, when filled nisms capable of growing in the prod- and sealed, is significantly affected by uct at nonrefrigerated conditions (over the enclosed product. 50 °F or 10 °C) at which the product is (k) Incubation tests. Tests in which intended to be held during distribution the thermally processed product is and storage. Shelf stability and shelf

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stable are synonymous with commer- servations, along with any corrective cial sterility and commercially sterile, actions, shall be recorded. Visual ex- respectively. aminations shall be conducted with (v) Thermal process. The heat treat- sufficient frequency to ensure proper ment necessary to achieve shelf stabil- closure and should be conducted at ity as determined by the establish- least every 30 minutes of continuous ment’s processing authority. It is closing machine operation. Additional quantified in terms of: visual examinations shall be made by (1) Time(s) and temperature(s); or the closure technician at the beginning (2) Minimum product temperature. of production, immediately following (w) Venting. The removal of air from every jam in the closing machine and a retort before the start of process tim- after closing machine adjustment (in- ing. cluding adjustment for changes in con- (x) Water activity. The ratio of the tainer size). water vapor pressure of the product to (2) Teardown examinations. Teardown the vapor pressure of pure water at the examinations of double seams formed same temperature. by each closing machine head shall be § 318.301 Containers and closures. performed by a closure technician at a frequency sufficient to ensure proper (a) Examination and cleaning of empty closure. These examinations should be containers. (1) Empty containers, clo- made at intervals of not more than 4 sures, and flexible pouch roll stock hours of continuous closing machine shall be evaluated by the establish- operation. At least one container from ment to ensure that they are clean and each closing head shall be examined on free of structural defects and damage the packer’s end during each regular that may affect product or container examination period. Examination re- integrity. Such an examination should sults along with any necessary correc- be based upon a statistical sampling plan. tive actions, such as adjusting or re- (2) All empty containers, closures, pairing the closing machine, shall be and flexible pouch roll stock shall be promptly recorded by the closure tech- stored, handled, and conveyed in such a nician. The establishment shall have manner that will prevent soiling and container specification guidelines for damage that could affect the hermetic double seam integrity on file and avail- condition of the sealed container. able for review by Program employees. (3) Just before filling, rigid contain- A teardown examination of the can ers shall be cleaned to prevent incorpo- maker’s end shall be performed on at ration of foreign matter into the fin- least one container selected from each ished product. Closures, semirigid con- closing machine during each examina- tainers, preformed flexible pouches, tion period except when teardown ex- and flexible pouch roll stock contained aminations are made on incoming in original wrappings do not need to be empty containers or when, in the case cleaned before use. of self-manufactured containers, the (b) Closure examinations for rigid con- containers are made in the vicinity of tainers (cans)—(1) Visual examinations. A the establishment and the container closure technician shall visually exam- plant records are made available to ine the double seams formed by each Program employees. Additional tear- closing machine head. When seam de- down examinations on the packer’s end fects (e.g., cutovers, sharpness, should be made at the beginning of pro- knocked down flanges, false seams, duction, immediately following every droops) are observed, necessary correc- jam in a closing machine and after tive actions, such as adjusting or re- closing machine adjustment (including pairing the closing machine, shall be adjustment for a change in container taken. In addition to the double seams, size). The following procedures shall be the entire container shall be examined used in teardown examinations of dou- for product leakage or obvious defects. ble seams: A visual examination shall be per- (i) One of the following two methods formed on at least one container from shall be employed for dimensional each closing machine head, and the ob- measurements of the double seam.

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(a) Micrometer measurement. For cylin- (1) Double seam length—W; drical containers, measure the follow- (2) Double seam thickness—S; ing dimensions (Figure 1) at three (3) Body hook length—BH; and points approximately 120 degrees apart (4) Cover hook length—CH. on the double seam excluding and at Maximum and minimum values for least one-half inch from the side seam each dimensional measurement shall juncture: be recorded by the closure technician.

(b) Seamscope or seam projector. Re- lap. Seam thickness shall be obtained quired measurements of the seam include thickness, body hook, and over-

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by micrometer. For cylindrical con- cient to ensure proper closure. These tainers, at least two locations, exclud- examinations should be made either ing the side seam juncture, shall be before or after thermal processing and used to obtain the required measure- at intervals of not more than 4 hours of ments. continuous closing machine operation. (ii) Seam tightness. Regardless of the At least one container from each clos- dimensional measurement method used ing machine shall be examined during to measure seam dimensions, at a min- each regular examination period. Ex- imum, the seam(s) examined shall be amination results along with any nec- stripped to assess the degree of wrin- essary corrective actions, such as ad- kling. justing or repairing the closing ma- (iii) Side seam juncture rating. Regard- chine, shall be promptly recorded by less of the dimensional measurement the closure technician. The establish- method used to measure seam dimen- ment shall have specification guide- sions, the cover hook shall be stripped lines for closure integrity on file and to examine the cover hook droop at the available for review by Program em- juncture for containers having side ployees. Additional closure examina- seams. tions should be made at the beginning (iv) Examination of noncylindrical con- of production, immediately following tainers. Examination of noncylindrical every jam in the closing machine, and containers (e.g., square, rectangular, after closing machine adjustment (in- ‘‘D’’-shaped, and irregularly-shaped) cluding adjustment for a change in shall be conducted as described in para- container size). graphs (b)(2) (i), (ii), and (iii) of this (d) Closure examinations for semirigid section except that the required dimensional measurements shall be made on and flexible containers—(1) Heat seals— the double seam at the points listed in (i) Visual examinations. A closure tech- the establishment’s container speci- nician shall visually examine the seals fication guidelines. formed by each sealing machine. When (c) Closure examinations for glass con- sealing defects are observed, necessary tainers—(1) Visual examinations. A clo- corrective actions, such as adjusting or sure technician shall visually assess repairing the sealing machine, shall be the adequacy of the closures formed by taken and recorded. In addition to ex- each closing machine. When closure de- amining the heat seals, the entire con- fects, such as loose or cocked caps, tainer shall be examined for product fractured or cracked containers and leakage or obvious defects. Visual ex- low vacuum jars, are observed, nec- aminations shall be performed before essary corrective actions, such as ad- and after the thermal processing oper- justing or repairing the closing ma- ation and with sufficient frequency to chine shall be taken and recorded. In ensure proper closure. These examina- addition to the closures, the entire tions should be conducted at least in container shall be examined for de- accordance with a statistical sampling fects. Visual examinations shall be plan. All defects noted and corrective made with sufficient frequency to en- actions taken shall be promptly re- sure proper closure and should be con- corded. ducted at least every 30 minutes of con- (ii) Physical tests. Tests determined tinuous closing machine operation. Ad- by the establishment as necessary to ditional visual examinations shall be assess container integrity shall be con- made by the closure technician and the ducted by the closure technician at a observations recorded at the beginning frequency sufficient to ensure proper of production, immediately following closure. These tests shall be performed every jam in the closing machine, and after the thermal processing operation after closing machine adjustment (in- and should be made at least every 2 cluding adjustment for a change in hours of continuous production. The container size). establishment’s acceptance guidelines (2) Closure examinations and tests. De- for each test procedure shall be on file pending upon the container and clo- and available for review by Program sure, tests shall be performed by a clo- employees. Test results along with any sure technician at a frequency suffi- necessary corrective actions, such as

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adjusting or repairing the sealing ma- If it is determined that any such chine, shall be recorded. change adversely affects the adequacy (2) Double seams on semirigid or of the process schedule, the processing flexible containers shall be examined authority shall amend the process and the results recorded as provided in schedule accordingly. paragraph (b) of this section. Any addi- (3) Complete records concerning all tional measurements specified by the aspects of the development or deter- container manufacturer shall also be mination of a process schedule, includ- made and recorded. ing any associated incubation tests, (e) Container coding. Each container shall be made available by the estab- shall be marked with a permanent, leg- lishment to the Program employee ible, identifying code mark. The mark upon request. shall, at a minimum, identify in code (c) Submittal of process information. (1) the product (unless the product name Prior to the processing of canned prod- lithographed or printed elsewhere on uct for distribution in commerce, the the container) and the day and year establishment shall provide the inspec- the product was packed. tor at the establishment with a list of (f) Handling of containers after closure. the process schedules (including alter- (1) Containers and closures shall be nate schedules) along with any addi- protected from damage which may tional applicable information, such as cause defects that are likely to affect the retort come-up operating proce- the hermetic condition of the contain- dures and critical factors. ers. The accumulation of stationary (2) Letters or other written commu- containers on moving conveyors should nications from a processing authority be minimized to avoid damage to the recommending all process schedules containers. shall be maintained on file by the es- (2) The maximum time lapse between tablishment. Upon request by Program closing and initiation of thermal proc- employees, the establishment shall essing shall be 2 hours. However, the make available such letters or written Administrator may specify a shorter communications (or copies thereof). If period of time when considered nec- critical factors are identified in the essary to ensure product safety and process schedule, the establishment stability. A longer period of time be- shall provide the inspector with a copy tween closing and the initiation of of the procedures for measuring, con- thermal processing may be permitted trolling, and recording these factors, by the Administrator. along with the frequency of such meas- (Approved by the Office of Management and urements, to ensure that the critical Budget under control number 0583–0015) factors remain within the limits used to establish the process schedule. Once § 318.302 Thermal processing. submitted, the process schedules and (a) Process schedules. Prior to the associated critical factors and the pro- processing of canned product for dis- cedures for measuring (including the tribution in commerce, an establish- frequency), controlling, and recording ment shall have a process schedule (as of critical factors shall not be changed defined in § 318.300(n) of this subpart) without the prior written submittal of for each canned meat product to be the revised procedures (including sup- packed by the establishment. porting documentation) to the inspec- (b) Source of process schedules. (1) tor at the establishment. Process schedules used by an establish- (Approved by the Office of Management and ment shall be developed or determined Budget under control number 0583–0015) by a processing authority. (2) Any change in product formula- § 318.303 Critical factors and the appli- tion, ingredients, or treatments that cation of the process schedule. are not already incorporated in a proc- Critical factors specified in the process schedule and that may adversely af- ess schedule shall be measured, con- fect either the product heat penetra- trolled and recorded by the establish- tion profile or sterilization value re- ment to ensure that these factors requirements shall be evaluated by the main within the limits used to estab- establishment’s processing authority. lish the process schedule. Examples of

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factors that are often critical to proc- uct from bypassing the thermal process schedule adequacy may include: essing operation. (a) General. (1) Maximum fill-in (c) Initial temperature. The initial weight or drained weight; temperature of the contents of the (2) Arrangement of pieces in the con- coldest container to be processed shall tainer; be determined and recorded by the es- (3) Container orientation during ther- tablishment at the time the processing mal processing; cycle begins to assure that the tem- (4) Product formulation; perature of the contents of every con- (5) Particle size; tainer to be processed is not lower than (6) Maximum thickness for flexible, the minimum initial temperature spec- and to some extent semirigid contain- ified in the process schedule. Thermal ers during thermal processing; processing systems which subject the (7) Maximum pH; filled and sealed containers to water at (8) Percent salt; any time before process timing begins (9) Ingoing (or formulated) nitrite shall be operated to assure that such level (ppm); (10) Maximum water activity; and water will not lower the temperature (11) Product consistency or viscosity. of the product below the minimum ini- (b) Continuous rotary and batch agitat- tial temperature specified in the proc- ing retorts. (1) Minimum headspace; and ess schedule. (2) Retort reel speed. (d) Timing devices. Devices used to (c) Hydrostatic retorts. (1) Chain or time applicable thermal processing op- conveyor speed. eration functions or events, such as (d) Steam/air retorts. (1) Steam/air process schedule time, come-up time ratio; and and retort venting, shall be accurate to (2) Heating medium flow rate. assure that all such functions or events are achieved. Pocket watches and wrist § 318.304 Operations in the thermal watches are not considered acceptable processing area. timing devices. Analog and digital (a) Posting of processes. Process sched- clocks are considered acceptable. If ules (or operating process schedules) such clocks do not display seconds, all for daily production, including mini- required timed functions or events mum initial temperatures and operat- shall have at least a 1-minute safety ing procedures for thermal processing factor over the specified thermal proc- equipment, shall be posted in a con- essing operation times. Temperature/ spicuous place near the thermal proc- time recording devices shall correspond essing equipment. Alternatively, such within 15 minutes to the time of the information shall be available to the day recorded on written records re- thermal processing system operator quired by § 318.306. and the inspector. (e) Measurement of pH. Unless other (b) Process indicators and retort traffic methods are approved by the Adminis- control. A system for product traffic trator, potentiometric methods using control shall be established to prevent electronic instruments (pH meters) product from bypassing the thermal shall be used for making pH determina- processing operation. Each basket, tions when a maximum pH value is crate or similar vehicle containing un- specified as a critical factor in a proc- processed product, or at least one visi- ess schedule. ble container in each vehicle, shall be plainly and conspicuously marked with (Approved by Office of Management and a heat sensitive indicator that will vis- Budget under control number 0583–0015) ually indicate whether such unit has been thermally processed. Exposed § 318.305 Equipment and procedures for heat processing systems. heat sensitive indicators attached to container vehicles shall be removed be- (a) Instruments and controls common to fore such vehicles are refilled with un- different thermal processing systems—(1) processed product. Container loading Indicating temperature devices. Each re- systems for crateless retorts shall be tort shall be equipped with at least one designed to prevent unprocessed prod- indicating temperature device that

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measures the actual temperature with- temperature. The temperature record- in the retort. The indicating tempera- ing chart should be adjusted to agree ture device, not the temperature/time with, but shall never be higher than, recording device, shall be used as the the known accurate indicating tem- reference instrument for indicating the perature device. A means of preventing process temperature. unauthorized changes in the adjust- (i) Mercury-in-glass thermometers. A ment shall be provided. For example, a mercury-in-glass thermometer shall lock or a notice from management have divisions that are readable to 1F posted at or near the recording device °(or 0.5C°) and whose scale contains not warning that only authorized persons more than 17F°/inch (or 4.0C°/cm) of are permitted to make adjustments, graduated scale. Each mercury-in-glass are satisfactory means for preventing thermometer shall be tested for accu- unauthorized changes. Air-operated racy against a known accurate stand- temperature controllers shall have ade- ard upon installation and at least once quate filter systems to ensure a supply a year to ensure its accuracy. Records of clean, dry air. The recorder timing that specify the date, standard used, mechanism shall be accurate. test method, and the person or testing (i) Chart-type devices. Devices using authority performing the test shall be charts shall be used only with the cor- maintained on file by the establish- rect chart. Each chart shall have a ment and made available to Program working scale of not more than 55F°/ employees. A mercury-in-glass ther- inch (or 12C°/cm) within a range of 20F mometer that has a divided mercury °(or 11C°) of the process temperature. column or that cannot be adjusted to Chart graduations shall not exceed 2F the standard shall be repaired and test- degrees (or 1C degree) within a range of ed for accuracy before further use, or 10F degrees (or 5C degrees) of the proc- replaced. ess temperature. Multipoint plotting (ii) Other devices. In lieu of mercury- chart-type devices shall print tempera- in-glass thermometers, the Adminis- ture readings at intervals that will as- trator, upon request, will consider sure that the parameters of the process other indicating temperature devices, time and process temperature have such as resistance temperature detec- been met. The frequency of recording tors. Any such device that is approved should not exceed 1-minute intervals. shall, upon installation and at least (ii) Other devices. In lieu of chart-type once a year thereafter, be tested for ac- devices, the Administrator will con- curacy against a known accurate sider for approval other recording de- standard. Records that specify the date, standard used, test method, and vices upon request. the person or testing authority per- (3) Steam controllers. Each retort shall forming the test shall be maintained be equipped with an automatic steam on file by the establishment and made controller to maintain the retort tem- available to Program employees. Any perature. This may be a recording/con- such device which cannot be adjusted trolling instrument when combined to the standard shall be replaced, or re- with a temperature/time recording de- paired and tested for accuracy before vice. further use. (4) Air valves. All air lines connected (2) Temperature/time recording devices. to retorts designed for pressure proc- Each thermal processing system shall essing in steam shall be equipped with be equipped with at least one tempera- a globe valve or other equivalent-type ture/time recording device to provide a valve or piping arrangement that will permanent record of temperatures prevent leakage of air into the retort within the thermal processing system. during the process cycle. This recording device may be combined (5) Water valves. All retort water lines with the steam controller and may be a that are intended to be closed during a recording/controlling instrument. process cycle shall be equipped with a When compared to the known accurate globe valve or other equivalent-type indicating temperature device, the re- valve or piping arrangement that will cording accuracy shall be equal to or prevent leakage of water into the re- better than 1F °(or 0.5C°) at the process tort during the process cycle.

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(b) Pressure processing in steam—(1) each end along the top of the retort. Batch still retorts. (i) The basic require- Additional bleeders shall be located ments and recommendations for indi- not more than 8 feet (2.4 m) apart along cating temperature devices and tem- the top. Bleeders may be installed at perature/time recording devices are depositions other than those specified scribed in paragraphs (a) (1) and (2) of above, as long as the establishment has this section. Additionally, bulb sheaths heat distribution data or other docu- or probes of indicating temperature de- mentation from the manufacturer or vices and probes of temperature/time from a processing authority dem- recording devices shall be installed ei- onstrating that the bleeders accom- ther within the retort shell or in exter- plish removal of air and circulate the nal wells attached to the retort. Exter- steam within the retort. This informa- nal wells shall be connected to the re- tion shall be maintained on file by the tort through at least a 3⁄4 inch (1.9 cm) establishment and made available to diameter opening and equipped with a Program employees for review. All 1⁄16 inch (1.6 mm) or larger bleeder bleeders shall be arranged in a way opening so located as to provide a con- that enables the retort operator to ob- stant flow of steam past the length of serve that they are functioning prop- the bulb or probe. The bleeder for ex- erly. Vertical retorts shall have at ternal wells shall emit steam continu- least one bleeder opening located in ously during the entire thermal proc- the portion of the retort opposite the essing period. steam inlet. All bleeders shall be ar- (ii) Steam controllers are required as ranged so that the retort operator can described under paragraph (a)(3) of this observe that they are functioning prop- section. erly. In retorts having a steam inlet (iii) Steam inlet. The steam inlet to above the level of the lowest container, each retort shall be large enough to a bleeder shall be installed in the bot- provide steam for proper operation of tom of the retort to remove conden- the retort, and shall enter at a point to sate. The condensate bleeder shall be facilitate air removal during venting. so arranged that the retort operator (iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be employ bottom retort crate supports. checked with sufficient frequency to Baffle plates shall not be used in the ensure adequate removal of conden- bottom of retorts. sate. Visual checks should be per- (v) Steam spreader. Perforated steam formed at intervals of not more than 15 spreaders, if used, shall be maintained minutes and the results recorded. to ensure they are not blocked or oth- Intermittent condensate removal sys- erwise inoperative. Horizontal still re- tems shall be equipped with an auto- torts shall be equipped with perforated matic alarm system that will serve as steam spreaders that extend the full a continuous monitor of condensate length of the retort unless the ade- bleeder functioning. The automatic quacy of another arrangement is docu- alarm system shall be tested at the be- mented by heat distribution data or ginning of each shift for proper func- other documentation from a processing tioning and the results recorded. If the authority. Such information shall be alarm system is not functioning prop- maintained on file by the establish- erly, it must be repaired before the re- ment and made available to Program tort is used. employees for review. (vii) Stacking equipment—(a) Equip- (vi) Bleeders and condensate removal. ment for holding or stacking containers in Bleeders, except those for external retorts. Crates, trays, gondolas, carts, wells of temperature devices, shall and other vehicles for holding or stack- have 1⁄8 inch (or 3 mm) or larger opening product containers in the retort ings and shall be wide open during the shall be so constructed to ensure steam entire process, including the come-up circulation during the venting, come- time. For horizontal still retorts, up, and process times. The bottom of bleeders shall be located within ap- each vehicle shall have perforations at proximately 1 foot (or 30 cm) of the least 1 inch (2.5 cm) in diameter on 2 outermost locations of containers at inch (or 5 cm) centers or the equivalent

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unless the adequacy of another ar- retorts shall lead to the atmosphere. rangement is documented by heat dis- The manifold header shall not be contribution data or other documentation trolled by a valve and shall be of a size from a processing authority and such such that the cross-sectional area is at information is maintained on file by least equal to the total cross-sectional the establishment and made available area of all connecting retort manifold to Program employees for review. pipes from the maximum number of re- (b) Divider plates. Whenever one or torts to be vented simultaneously. more divider plates are used between (c) Some typical installations and op- any two layers of containers or placed erating procedures are described below. on the bottom of a retort vehicle, the Other retort installations, vent piping establishment shall have on file docu- arrangements, operating procedures or mentation that the venting procedure auxiliary equipment such as divider allows the air to be removed from the plates may be used provided there is retort before timing of the thermal documentation that the air is removed process is started. Such documentation from the retort before the process is shall be in the form of heat distribu- started. Such documentation shall be tion data or documentation from a in the form of heat distribution data or processing authority. This information other documentation from the equip- shall be made available to Program ment manufacturer or processing au- employees for review. thority. This information shall be (viii) Bleeder and vent mufflers. If muf- maintained on file by the establish- flers are used on bleeders or vent sys- ment and made available to Program tems, the establishment shall have on employees for review. file documentation that the mufflers do not impede the removal of air from (d) For crateless retort installations, the retort. Such documentation shall the establishment shall have heat dis- consist of either heat distribution data tribution data or other documentation or documentation from the muffler from the equipment manufacturer or manufacturer or from a processing au- from a processing authority that dem- thority. This information shall be onstrates that the venting procedure made available to Program employees used accomplishes the removal of air for review. and condensate. This information shall (ix) Vents—(a) Vents shall be located be maintained on file by the establish- in that portion of the retort opposite ment and made available to Program the steam inlet and shall be designed, employees for review. installed, and operated in such a way (e) Examples of typical installations that air is removed from the retort be- and operating procedures that comply fore timing of the thermal process is with the requirements of this section started. Vents shall be controlled by a are as follows: gate, plug cock, or other full-flow valve (1) Venting horizontal retorts. which shall be fully opened to permit (i) Venting through multiple 1 inch rapid removal of air from retorts dur- (2.5 cm) vents discharging directly to ing the venting period. the atmosphere. (b) Vents shall not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross- sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be connected to a closed drain without an atmospheric break in the Specifications (Figure 1): One, 1-inch (2.5 cm) line. A manifold header connecting vent for every 5 feet (1.5 m) of retort length, vents or manifolds from several still equipped with a gate, plug cock, or other

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full-flow valve and discharging to atmos- spreader vent shall be wide open for at least phere. The end vents shall not be more than 5 minutes and to at least 225 °F (or 107 °C), or 21⁄2 feet (or 75 cm) from ends of retort. Vent- for at least 7 minutes and to at least 220 °F ing method (Figure 1): Vent valves shall be (or 104.5 °C). wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or at least 7 minutes (iv) Venting through a single 21⁄2 inch and to at least 220 °F (or 104.5 °C). (6.4 cm) top vent for retorts not exceed- (ii) Venting through multiple 1 inch ing 15 feet (4.6 m) in length. (2.5 cm) vents discharging through a manifold to the atmosphere.

Specifications (Figure 4): A 21⁄2 inch (6.4 cm) vent equipped with a 21⁄2 inch (6.4 cm) gate, Specifications (Figure 2): One, 1-inch (2.5 cm) plug cock, or other full-flow valve and lo- vent for every 5 feet (1.5 m) of retort length; cated within 2 feet (61 cm) of the center of vents not over 21⁄2 feet (or 75 cm) from ends the retort. of retort; size of manifold for retorts less Venting method (Figure 4): The vent valve than 15 feet (4.6 m) in length, 21⁄2 inches (6.4 shall be wide open for at least 4 minutes and cm), and for retorts 15 feet (4.6 m) and over to at least 220 °F (or 104.5 °C). in length, 3 inches (7.6 cm). (2) Venting vertical retorts. Venting method (Figure 2): The manifold 1 vent gate, plug cock, or other full-flow valve (i) Venting through a 1 ⁄2 inch (3.8 cm) shall be wide open for at least 6 minutes and overflow. to at least 225 °F (or 107 °C) or for at least 8 minutes and to at least 220 °F (or 104.5 °C). (iii) Venting through water spreaders.

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Specifications (Figure 5): A 11⁄2 inch (3.8 cm) Venting method (Figure 5): The vent valve overflow pipe equipped with a 11⁄2 inch (3.8 shall be wide open for at least 4 minutes and cm) gate, plug cock, or other full-flow valve to at least 218 °F (or 103.5 °C), or for at least and with not more than 6 feet (1.8 m) of 11⁄2 5 minutes and to at least 215 °F (or 101.5 °C). inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold (ii) Venting through a single 1 inch header. (2.5 cm) side or top vent.

Specifications (Figure 6 or 7): A 1 inch (2.5 ameter opening and equipped with a 1⁄16 cm) vent in lid or top side, equipped with a (1.6 mm) or larger bleeder opening so gate, plug cock, or other full-flow valve and located as to provide a constant flow of discharging directly into the atmosphere or steam past the length of the bulbs or to a manifold header. Venting method (Figure 6 or 7): The vent probes. The bleeder for external wells valve shall be wide open for at least 5 min- shall emit steam continuously during utes and to at least 230 °F (110 °C), or for at the entire thermal processing period. least 7 minutes and to at least 220 °F (or 104.5 (ii) Steam controllers are required as °C). described in paragraph (a)(3) of this (2) Batch agitating retorts. (i) The section. basic requirements for indicating tem- (iii) Steam inlet. The steam inlet to perature devices and temperature/time each retort shall be large enough to recording devices are described in para- provide steam for proper operation of graphs (a) (1) and (2) of this section. the retort and shall enter at a point(s) Additionally, bulb sheaths or probes of to facilitate air removal during vent- indicating temperature devices and ing. probes of temperature/time recording (iv) Bleeders. Bleeders, except those devices shall be installed either within for external wells of temperature de- the retort shell or in external wells at- vices, shall be 1⁄8 inch (or 3 mm) or larg- tached to the retort. External wells er and shall be wide open during the shall be connected to the retort entire process including the come-up through at least a 3⁄4 inch (1.9 cm) di- time. Bleeders shall be located within

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approximately 1 foot (or 30 cm) of the speed shall be determined and recorded outermost location of containers, at at least once during process timing of each end along the top of the retort. each retort load processed. Alter- Additional bleeders shall be located natively, a recording tachometer can not more than 8 feet (2.4 m) apart along be used to provide a continuous record the top. Bleeders may be installed at of the speed. The accuracy of the re- positions other than those specified cording tachometer shall be deter- above, as long as the establishment has mined and recorded at least once per heat distribution data or other docu- shift by checking the retort or reel mentation from the manufacturer or speed using an accurate stopwatch. A from a processing authority that the means of preventing unauthorized bleeders accomplish removal of air and speed changes on retorts shall be pro- circulate the steam within the retort. vided. For example, a lock or a notice This information shall be maintained from management posted at or near on file by the establishment and made the speed adjustment device warning available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is function- graphs (a) (1) and (2) of this section. ing properly. The condensate bleeder Additionally, bulb sheaths or probes of shall be checked with sufficient fre- indicating temperature devices and quency to ensure adequate removal of probes of temperature/time recording condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) dian automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s)

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to facilitate air removal during vent- the alarm system is not functioning ing. properly, it must be repaired before the (iv) Bleeders. Bleeders, except those retort is used. for external wells of temperature de- (vi) Retort speed timing. The rota- vices, shall be 1⁄8 inch (3.2 mm) or larg- tional speed of the retort shall be spec- er and shall be wide open during the ified in the process schedule. The speed entire process, including the come-up shall be adjusted as specified, and re- time. B!eeders shall be located within corded by the establishment when the approximately 1 foot (or 30 cm) of the retort is started, and checked and re- outermost location of containers at corded at intervals not to exceed 4 each end along the top of the retort. hours to ensure that the correct retort Additional bleeders shall be located speed is maintained. Alternatively, a not more than 8 feet (2.4 m) apart along recording tachometer may be used to the top of the retort. Bleeders may be provide a continuous record of the installed at positions other than those speed. If a recording tachometer is specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who deve!oped the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time recorder shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient shall be located in the steam dome frequency to ensure adequate removal near the steam/water interface. Where of condensate. Visual checks should be the process schedule specifies mainte- performed at intervals of not more nance of particular water temperatures than 15 minutes and the results rein the hydrostatic water legs, at least corded. Intermittent condensate re- one indicating temperature device moval systems shall be equipped with shall be located in each hydrostatic an automatic alarm system that will water leg so that it can accurately serve as a continuous monitor of con- measure water temperature and be eas- densate bleeder functioning. The auto- ily read. The temperature/time re- matic alarm system shall be tested at corder probe shall be installed either the beginning of each shift for proper within the steam dome or in a well at- functioning and the results recorded. If tached to the dome. Each probe shall

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have a 1⁄16 inch (1.6 mm) or larger bleed- (vii) Bleeders and vent mufflers. If muf- er opening which emits steam continu- flers are used on bleeders or vent sys- ously during the processing period. Ad- tems, the establishment shall have doc- ditional temperature/time recorder umentation that the muffler do not im- probes shall be installed in the hydro- pede the removal of air from the retort. static water legs if the process sched- Such documentation shall consist of ei- ule specifies maintenance of particular ther heat distribution data or other temperatures in these water legs. documentation from the muffler manu- (ii) Steam controllers are required as facturer or from a processing author- described in paragraph (a)(3) of this ity. This information shall be main- section. tained on file by the establishment and (iii) Steam inlet. The steam inlets made available to Program employees shall be large enough to provide steam for review. for proper operation of the retort. (c) Pressure processing in water—(1) (iv) Bleeders. Bleeder openings 1⁄4 inch Batch still retorts. (i) The basic require- (or 6 mm) or larger shall be located in ments for indicating temperature de- the steam chamber(s) opposite the vices and temperature/time recording point of steam entry. Bleeders shall be devices are described in paragraphs wide open and shall emit steam con- (a)(1) and (2) of this section. Addition- tinuously during the entire process, in- ally, bulbs or probes of indicating tem- cluding the come-up time. All bleeders perature devices shall be located in shall be arranged in such a way that such a position that they are beneath the operator can observe that they are the surface of the water throughout functioning properly. the process. On horizontal retorts, the (v) Venting. Before the start of proc- indicating temperature device bulb or essing operations, the retort steam chamber(s) shall be vented to ensure probe shall be inserted directly into removal of air. Heat distribution data the retort shell. In both vertical and or other documentation from the man- horizontal retorts, the indicating tem- ufacturer or from a processing author- perature device bulb or probe shall ex- ity demonstrating that the air is re- tend directly into the water a mini- moved from the retort prior to process- mum of 2 inches (or 5 cm) without a ing shall be kept on file at the estab- separable well or sleeve. In vertical re- lishment and made available to Pro- torts equipped with a recorder/control- gram employees for review. ler, the controller probe shall be lo- (vi) Conveyor speed. The conveyor cated at the bottom of the retort below speed shall be calculated to obtain the the lowest crate rest in such a position required process time and recorded by that the steam does not strike it di- the establishment when the retort is rectly. In horizontal retorts so started. The speed shall be checked and equipped, the controller probe shall be recorded at intervals not to exceed 4 located between the water surface and hours to ensure that the correct con- the horizontal plane passing through veyor speed is maintained. A recording the center of the retort so that there is device may be used to provide a contin- no opportunity for direct steam im- uous record of the conveyor speed. pingement on the controller probe. Air- When a recording device is used, the operated temperature controllers shall speed shall be manually checked have filter systems to ensure a supply against an accurate stopwatch at least of clean, dry air. once per shift by the establishment. A (ii) Pressure recording device. Each re- means of preventing unauthorized tort shall be equipped with a pressure speed changes of the conveyor shall be recording device which may be com- provided. For example, a lock or a no- bined with a pressure controller. tice from management posted at or (iii) Steam controllers are required as near the speed adjustment device warn- described in paragraph (a)(3) of this ing that only authorized persons are section. permitted to make adjustments are satisfactory means of preventing unau- (iv) Heat distribution. Heat distribu- thorized changes. tion data or other documentation from

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the equipment manufacturer or a proc- entering the system. Overriding air or essing authority demonstrating uni- steam pressure shall be maintained form heat distribution within the re- continuously during the come-up, ther- tort shall be kept on file at the estab- mal processing, and cooling periods. If lishment and made available to Pro- air is used to promote circulation, it gram employees for review. shall be introduced into the steam line (v) Crate supports. A bottom crate at a point between the retort and the support shall be used in vertical re- steam control valve at the bottom of torts. Baffle plates shall not be used in the retort. The adequacy of the air cir- the bottom of the retort. culation for maintaining uniform heat (vi) Stacking equipment. For filled distribution within the retort shall be flexible containers and, where applica- documented by heat distribution data ble, semirigid containers, stacking or other documentation from a process- equipment shall be designed to ensure ing authority, and such data shall be that the thickness of the filled contain- maintained on file by the establish- ers does not exceed that specified in ment and made available to Program the process schedule and that the con- employees for review. tainers do not become displaced and (x) Water recirculation. When a water overlap or rest on one another during recirculation system is used for heat the thermal process. distribution, the water shall be drawn (vii) Drain valve. A nonclogging, from the bottom of the retort through water-tight drain valve shall be used. a suction manifold and discharged Screens shall be installed over all drain through a spreader that extends the openings. length or circumference of the top of (viii) Water level. There shall be a means of determining the water level the retort. The holes in the water in the retort during operation (i.e., by spreader shall be uniformly distrib- using a gauge, electronic sensor, or uted. The suction outlets shall be pro- sight glass indicator). For retorts re- tected with screens to keep debris from quiring complete immersion of con- entering the recirculation system. The tainers, water shall cover the top layer pump shall be equipped with a pilot of containers during the entire come- light or a similar device to warn the up time and thermal processing periods operator when it is not running, and and should cover the top layer of con- with a bleeder to remove air when tainers during cooling. For retorts starting operations. Alternatively, a using cascading water or water sprays, flow-meter alarm system can be used the water level shall be maintained to ensure proper water circulation. The within the range specified by the retort adequacy of water circulation for manufacturer or processing authority maintaining uniform heat distribution during the entire come-up, thermal within the retort shall be documented processing, and cooling periods. A by heat distribution or other docu- means to ensure that water circulation mentation from a processing authority continues as specified throughout the and such data shall be maintained on come-up, thermal processing, and cool- file by the establishment and made ing periods shall be provided. The re- available to Program employees for retort operator shall check and record view. Alternative methods for recir- the water level at intervals to ensure it culation of water in the retort may be meets the specified processing param- used, provided there is documentation eters. in the form of heat distribution data or (ix) Air supply and controls. In both other documentation from a processing horizontal and vertical still retorts, a authority maintained on file by the es- means shall be provided for introducing tablishment and made available to compressed air or steam at the pres- Program employees for review. sure required to maintain container in- (xi) Cooling water entry. In retorts for tegrity. Compressed air and steam processing product packed in glass jars, entry shall be controlled by an auto- the incoming cooling water should not matic pressure control unit. A non- directly strike the jars, in order to return valve shall be provided in the minimize glass breakage by thermal air supply line to prevent water from shock.

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(2) Batch agitating retorts. (i) The the pressure required to maintain con- basic requirements and recommenda- tainer integrity. Compressed air and tions for indicating temperature de- steam entry shall be controlled by an vices and temperature/time recording automatic pressure control unit. A devices are described in paragraphs (a) nonreturn valve shall be provided in (1) and (2) of this section. Additionally, the air supply line to prevent water the indicating temperature device bulb from entering the system. Overriding or probe shall extend directly into the air or steam pressure shall be main- water without a separable well or tained continuously during the come- sleeve. The recorder/controller probe up, thermal processing, and cooling pe- shall be located between the water sur- riods. If air is used to promote circula- face and the horizontal plane passing tion, it shall be introduced into the through the center of the retort so that steam line at a point between the re- there is no opportunity for steam to di- tort and the steam control valve at the rectly strike the controller bulb or bottom of the retort. The adequacy of probe. the air circulation for maintaining uni- (ii) Pressure recording device. Each re- form heat distribution within the retort shall be equipped with a pressure tort shall be documented by heat dis- recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required data shall be maintained on file by the as described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from the equipment manufacturer or a proc- tort or reel speed timing shall be essing authority shall be kept on file checked before process timing begins by the establishment and made avail- and, if needed, adjusted as specified in able to Program employees for review. the process schedule. In addition, the (v) Stacking equipment. All devices rotational speed shall be determined used for holding product containers and recorded at least once during proc- (e.g., crates, trays, divider plates) shall ess timing of each retort load proc- be so constructed to allow the water to essed. Alternatively, a recording ta- circulate around the containers during chometer can be used to provide a con- the come-up and thermal process peri- tinuous record of the speed. The accu- ods. racy of the recording tachometer shall (vi) Drain valve. A nonclogging, be determined and recorded at least water-tight drain valve shall be used. once per shift by the establishment by Screens shall be installed over all drain checking the retort or reel speed using openings. an accurate stopwatch. A means of pre- (vii) Water level. There shall be a venting unauthorized speed changes on means of determining the water level retorts shall be provided. For example, in the retort during operation (i.e., by a lock or a notice from management using a gauge, electronic sensor, or posted at or near the speed adjustment sight glass indicator). Water shall com- device warning that only authorized pletely cover all containers during the persons are permitted to make adjust- entire come-up, thermal processing, ments are satisfactory means of pre- and cooling periods. A means to ensure venting unauthorized changes. that water circulation continues as (x) Water recirculation. If a water re- specified throughout the come-up, circulation system is used for heat dis- thermal processing, and cooling periods tribution, it shall be installed in such a shall be provided. The retort operator manner that water will be drawn from shall check and record the adequacy of the bottom of the retort through a suc- the water level with sufficient fre- tion manifold and discharged through a quency to ensure it meets the specified spreader which extends the length of processing parameters. the top of the retort. The holes in the (viii) Air supply and controls. Retorts water spreader shall be uniformly dis- shall be provided with a means for in- tributed. The suction outlets shall be troducing compressed air or steam at protected with screens to keep debris

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from entering the recirculation sys- file by the establishment and made tem. The pump shall be equipped with available to Program employees for re- a pilot light or a similar device to warn view. The circulation system shall be the operator when it is not running and checked to ensure its proper function- with a bleeder to remove air when ing and shall be equipped with a pilot starting operations. Alternatively, a light or a similar device to warn the flow-meter alarm system can be used operator when it is not functioning. to ensure proper water circulation. The Because of the variety of existing de- adequacy of water circulation for signs, reference shall be made to the maintaining uniform heat distribution equipment manufacturer for details of within the retort shall be documented installation, operation, and control. by heat distribution data or other doc- (5) The Administrator shall be noti- umentation from a processing author- fied immediately by the official estab- ity, and such data shall be maintained lishment of any such system in use or on file by the establishment and made placed into use on or after the effective available to Program employees for re- date of this rule. view. Alternative methods for recir- (e) Atmospheric cookers—(1) Tempera- culation of water in the retort may be ture/time recording device. Each atmos- used provided there is documentation pheric cooker (e.g., hot water bath) in the form of heat distribution data or shall be equipped with at least one other documentation from a processing temperature/time recording device in authority maintained on file by the es- accordance with the basic require- tablishment and made available to ments described in paragraph (a)(2) of Program employees for review. this section. (xi) Cooling water entry. In retorts for (2) Heat distribution. Each atmos- processing product packed in glass jars, pheric cooker shall be equipped and op- the incoming cooling water should not erated to ensure uniform heat distribu- directly strike the jars, in order to tion throughout the processing system minimize glass breakage by thermal during the thermal process. Heat dis- shock. tribution data or other documentation (d) Pressure processing with steam/air mixtures in batch retorts. (1) The basic from the manufacturer or a processing requirements for indicating tempera- authority demonstrating uniform heat ture devices and temperature/time re- distribution within the cooker shall be cording devices are described in para- kept on file by the establishment and graphs (a) (1) and (2) of this section. made available to Program employees Additionally, bulb sheaths or probes for review. for indicating temperature devices and (f) Other systems. All other systems temperature/time recording devices or not specifically delineated in this sec- controller probes shall be inserted dition and used for the thermal process- rectly into the retort shell in such a ing of canned product will be evaluated position that steam does not strike on a case-by-case basis by the them directly. Adminstrator. Systems will be ap- (2) Steam controllers are required as proved if they are found to conform to described in paragraph (a)(3) of this the applicable requirements of this sec- section. tion and to produce shelf stable prod- (3) Recording pressure controller. A re- ucts consistently and uniformly. cording pressure controller shall be (g) Equipment maintenance. (1) Upon used to control the air inlet and the installation, all instrumentation and steam/air mixture outlet. controls shall be checked by the estab- (4) Circulation of steam/air mixtures. A lishment for proper functioning and ac- means shall be provided for the circula- curacy and, thereafter, at any time tion of the steam/air mixture to pre- their functioning or accuracy is sus- vent formation of low-temperature pect. pockets. The efficiency of the circula- (2) At least once a year each thermal tion system shall be documented by processing system shall be examined by heat distribution data or other docu- an individual not directly involved in mentation from a processing authority, daily operations to ensure the proper and such data shall be maintained on functioning of the system as well as all

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auxiliary equipment and instrumenta- water so that there is a measurable re- tion. In addition, each thermal process- sidual of an acceptable sanitizer, per ing system should be examined before paragraph (h)(2) of this section, in the the resumption of operation following water at the point where the water an extended shutdown. exits the container cooling vessel; (3) Air and water valves that are in- (iii) System maintenance including tended to be closed during thermal procedures for the periodic cleaning processing shall be checked by the es- and sanitizing of the entire system; tablishment for leaks. Defective valves and shall be repaired or replaced as needed. (iv) Water quality standards, such as (4) Vent and bleeder mufflers shall be microbiological, chemical and phys- checked and maintained or replaced by ical, monitoring procedures including the establishment to prevent any re- the frequency and site(s) of sampling, duction in vent or bleeder efficiency. and the corrective actions taken when (5) When water spreaders are used for water quality standards are not met. venting, a maintenance schedule shall (i) Post-process handling of containers be developed and implemented to as- Containers shall be handled in a man- sure that the holes are maintained at ner that will prevent damage to the their original size. hermetic seal area. All worn and frayed (6) Records shall be kept on all main- belting, can retarders, cushions, and tenance items that could affect the the like shall be replaced with non- adequacy of the thermal process. porous materials. To minimize con- Records shall include the date and type tainer abrasions, particularly in the of maintenance performed and the per- seal area, containers should not remain son conducting the maintenance. stationary on moving conveyors. All (h) Container cooling and cooling post-process container handling equip- water. (1) Potable water shall be used ment should be kept clean so there is for cooling except as provided for in no buildup of microorganisms on sur- paragraphs (h) (2) and (3) of this sec- faces in contact with the containers. tion. (Approved by the Office of Management and (2) Cooling canal water shall be Budget under control number 0583–0015) chlorinated or treated with a chemical approved by the Administrator as hav- § 318.306 Processing and production ing a bactericidal effect equivalent to records. chlorination. There shall be a measur- At least the following processing and able residual of the sanitizer in the production information shall be re- water at the discharge point of the corded by the establishment: date of canal. Cooling canals shall be cleaned production; product name and style; and replenished with potable water to container code; container size and prevent the buildup of organic matter type; and the process schedule, includ- and other materials. ing the minimum initial temperature. (3) Container cooling waters that are Measurements made to satisfy the re- recycled or reused shall be handled in quirements of § 318.303 regarding the systems that are so designed, operated, control of critical factors shall be re- and maintained so there is no buildup corded. In addition, where applicable, of microorganisms, organic matter, the following information and data and other materials in the systems and shall also be recorded: in the waters. System equipment, such (a) Processing in steam—(1) Batch still as pipelines, holding tanks and cooling retorts. For each retort batch, record towers, shall be constructed and in- the retort number or other designa- stalled so that they can be cleaned and tion, the approximate number of con- inspected. In addition, the establish- tainers or the number of retort crates ment shall maintain, and make avail- per retort load, product initial tem- able to Program employees for review, perature, time steam on, the time and information on at least the following: temperature vent closed, the start of (i) System design and construction; process timing, time steam off, and the (ii) System operation including the actual processing time. The indicating rates of renewal with fresh, potable temperature device and the tempera- water and the means for treating the ture recorder shall be read at the same

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time at least once during process tim- for agitating hydrostatic retorts, the ing and the observed temperatures re- rotative chain speed, shall be deter- corded. mined and recorded at intervals of suf- (2) Batch agitating retorts. In addition ficient frequency to ensure compliance to recording the information required with the process schedule and should for batch, still steam retorts in para- be performed at least every 4 hours. graph (a)(1) of this section, record the (b) Processing in water—(1) Batch still functioning of the condensate bleed- retorts. For each retort batch, record er(s) and the retort or reel speed. the retort number or other designa- (3) Continuous rotary retorts. Record tion, the approximate number of con- the retort system number, the approxi- tainers or number of retort crates per mate total number of containers re- retort load, product initial tempera- torted, product initial temperature, ture, time steam on, the start of proc- time steam on, the time and tempera- ess timing, water level, water recir- ture vent closed, time process tempera- culation rate (if critical), overriding ture reached, the time the first can en- pressure maintained, time steam off, ters and the time the last can exits the and actual processing time. The indi- retort. The retort or reel speed shall be cating temperature device and the determined and recorded at intervals temperature recorder shall be read at not to exceed 4 hours. Readings of the the same time at least once during indicating temperature device(s) and process timing and the observed tem- temperature recorder(s) shall be made peratures recorded. and recorded at the time the first con- (2) Batch agitating retorts. In addition tainer enters the retort and thereafter to recording the information required with sufficient frequency to ensure in paragraph (b)(1) of this section, compliance with the process schedule. record the retort or reel speed. These observations should be made and (c) Processing in steam/air mixtures. recorded at intervals not exceeding 30 For each retort batch, record the re- minutes of continuous retort oper- tort number or other designation, the ation. Functioning of the condensate approximate number of containers or bleeder(s) shall be observed and re- number of retort crates per retort load, corded at the time the first container product initial temperature, time enters the retort and thereafter as steam on, venting procedure, if appli- specified in § 318.305(b)(3)(v). cable, the start of process timing, (4) Hydrostatic retorts. Record the re- maintenance of circulation of the tort system number, the approximate steam/air mixture, air flow rate or total number of containers retorted, forced recirculation flow rate (if criti- product initial temperature, time cal), overriding pressure maintained, steam on, the time and temperature time steam off, and actual processing vent(s) closed, time process tempera- time. The indicating temperature de- ture reached, time first containers vice and the temperature recorder shall enter the retort, time last containers be read at the same time at least once exit the retort, and, if specified in the during process timing and the observed process schedule, measurements of temperatures recorded. temperatures in the hydrostatic water (d) Atmospheric cookers—(1) Batch-type legs. Readings of the temperature indi- systems. For each cooker batch, record cating device, which is located in the the cooker number or other designa- steam/water interface, and the tem- tion and the approximate number of perature recording device shall be ob- containers. In addition, record all criti- served and the temperatures recorded cal factors of the process schedule such at the time the first containers enter as cooker temperature, initial tem- the steam dome. Thereafter, these in- perature, the time the thermal process struments shall be read and the tem- cycle begins and ends, hold time, and peratures recorded with sufficient fre- the final internal product temperature. quency to ensure compliance with the (2) Continuous-type systems. Record temperature specified in the process the cooker number or other designa- schedule and should be made at least tion, the time the first containers every hour of continuous retort oper- enter and the last containers exit a ation. Container conveyor speed, and cooker, and the approximate total

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number of containers processed. In ad- All container closure examination dition, record all critical factors of the records required in this subpart shall process schedule such as the initial be made available to Program employ- temperature, cooker speed, and final ees for review. internal product temperature. (d) Distribution of product. Records (Approved by the Office of Management and shall be maintained by the establish- Budget under control number 0583–0015) ment identifying initial distribution of the finished product to facilitate, if § 318.307 Record review and mainte- necessary, the segregation of specific nance. production lots that may have been (a) Process records. Charts from tem- contaminated or are otherwise unsound perature/time recording devices shall for their intended use. be identified by production date, con- (e) Retention of records. Copies of all tainer code, processing vessel number processing and production records re- or other designation, and other data as quired in § 318.306 shall be retained for necessary to enable correlation with no less than 1 year at the establish- the records required in § 318.306. Each ment, and for an additional 2 years at entry on a record shall be made at the the establishment or other location time the specific event occurs, and the from which the records can be made recording individual shall sign or ini- available to Program employees within tial each record form. No later than 1 3 working days. working day after the actual process, (Approved by the Office of Management and the establishment shall review all Budget under control number 0583–0015) processing and production records to ensure completeness and to determine § 318.308 Deviations in processing. if all product received the process (a) Whenever the actual process is schedule. All records, including the less than the process schedule or when temperature/time recorder charts and any critical factor does not comply critical factor control records, shall be with the requirements for that factor signed or initialed and dated by the as specified in the process schedule, it person conducting the review. All proc- shall be considered a deviation in processing and production records required essing. in this subpart shall be made available (b) Deviations in processing (or proc- to Program employees for review. ess deviations) shall be handled under (b) Automated process monitoring and an approved quality control program as recordkeeping. When requested by an es- provided in paragraph (c) of this sec- tablishment, the Administrator will tion or shall be handled in accordance consider the approval of automated with paragraph (d) of this section. process monitoring and recordkeeping (c) Any partial quality control pro- systems. An approved system, alone or gram or any portion of a total quality in combination with written records, control system for handling process de- shall be designed and operated in a viations shall be prepared and submit- manner which will ensure compliance ted to the Administrator for approval with the applicable requirements of in accordance with § 318.4. § 318.306. (d) Handling process deviations with- (c) Container closure records. Written out an approved quality control pro- records of all container closure exami- gram. (1) Deviations identified in-process. nations shall specify the container If a deviation is noted at any time be- code, the date and time of container fore the completion of the intended closure examination, the measure- process schedule, the establishment ment(s) obtained, and any corrective shall: actions taken. Records shall be signed (i) Immediately reprocess the prod- or initialed by the container closure uct using the full process schedule; or technician and shall be reviewed and (ii) Use an appropriate alternate signed by the establishment within 1 process schedule provided such a proc- working day after the actual produc- ess schedule has been established in action to ensure that the records are cordance with § 318.302 (a) and (b) and is complete and that the closing oper- filed with the inspector in accordance ations have been properly controlled. with § 318.302(c); or

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(iii) Hold the product involved and emergency still retort process shall be have the deviation evaluated by a proc- noted on the temperature/time record- essing authority to assess the safety ing device and entered on the other and stability of the product. Upon com- production records required in § 318.306. pletion of the evaluation, the establish- (b) Temperature drops. When the re- ment shall provide the inspector the tort temperature drops below the tem- following: perature specified in the process sched- (a) A complete description of the de- ule, the reel shall be stopped and the viation along with all necessary sup- following actions shall be taken: porting documentation; (1) For temperature drops of less (b) A copy of the evaluation report; than 10 °F (or 5.5 °C) either, (i) all con- and tainers in the retort shall be given an (c) A description of any product dis- emergency still process (developed per position actions, either taken or pro- § 318.302(b)) before the reel is restarted; posed. (ii) container entry to the retort shall (iv) Product handled in accordance be prevented and an emergency agitat- with paragraph (d)(1)(iii) of this section ing process (developed per § 318.302(b)) shall not be shipped from the establish- shall be used before container entry to ment until the Program has reviewed the retort is restarted; or (iii) container all of the information submitted and entry to the retort shall be prevented approved the product disposition ac- and the reel restarted to empty the re- tions. tort. The discharged containers shall (v) If an alternate process schedule is be reprocessed, repacked and reproc- used that is not on file with the inspec- essed, or destroyed. Product to be de- tor or if an alternate process schedule stroyed shall be handled as ‘‘U.S. In- is immediately calculated and used, spected and Condemned’’, as defined in the product shall be set aside for fur- § 318.2(ee) of this subchapter, and dis- ther evaluation in accordance with posed of in accordance with part 314 of paragraphs (d)(1)(iii) and (iv) of this this subchapter. section. (2) For temperature drops of 10 °F (or (vi) When a deviation occurs in a con- 5.5 °C) or more, all containers in the re- tinuous rotary retort, the product shall tort shall be given an emergency still be handled in accordance with para- process (developed per § 318.302(b)). The graphs (d)(1)(iii) and (iv) of this section time the reel was stopped and the time or in accordance with the following the retort was used for a still retort procedures: process shall be marked on the tem- (a) Emergency stops. perature/time recording device by the (1) When retort jams or breakdowns establishment and entered on the other occur during the processing operations, production records required in § 318.306. all containers shall be given an emer- Alternatively, container entry to the gency still process (developed per retort shall be prevented and the reel § 318.302(b)) before the retort is cooled restarted to empty the retort. The dis- or the retort shall be cooled promptly charged containers shall be either re- and all containers removed and either processed, repacked and reprocessed, or reprocessed, repacked and reprocessed, destroyed. Product to be destroyed or destroyed. Regardless of the proce- shall be handled as ‘‘U.S. Inspected and dure used, containers in the retort in- Condemned’’, as defined in § 301.2(ee) of take valve and in transfer valves be- this subchapter, and disposed of in ac- tween retort shells at the time of a jam cordance with part 314 of this sub- or breakdown shall be removed and ei- chapter. ther reprocessed, repacked and reproc- (2) Deviations identified through record essed and or destroyed. Product to be review. Whenever a deviation is noted destroyed shall be handled as ‘‘U.S. In- during review of the processing and spected and Condemned’’, as defined in production records required by § 318.307 § 301.2(ttt) of this subchapter, and dis- (a) and (b), the establishment shall posed of in accordance with part 314 of hold the product involved and the devi- this subchapter. ation shall be handled in accordance (2) The time the retort reel stopped with paragraphs (d)(1) (iii) and (iv) of and the time the retort is used for an this section.

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(e) Process deviation file. The estab- incubation temperature shall be ad- lishment shall maintain full records re- justed within the required range and garding the handling of each deviation. the incubation time extended for the Such records shall include, at a mini- time the sample containers were held mum, the appropriate processing and at the deviant temperature. If the incu- production records, a full description of bation temperature is at or above 103 the corrective actions taken, the eval- °F (or 39.5 °C) for more than 2 hours, uation procedures and results, and the the incubation test(s) shall be termi- disposition of the affected product. nated, the temperature lowered to Such records shall be maintained in a within the required range, and new separate file or in a log that contains sample containers incubated for the re- the appropriate information. The file quired time. or log shall be retained in accordance (iii) Product requiring incubation. with § 318.307(e) and shall be made Shelf stable product requiring incuba- available to Program employees upon tion includes: request. (a) Low acid products as defined in (Approved by the Office of Management and § 318.300(m); and Budget under control number 0583–0015) (b) Acidified low acid products as de- [51 FR 45619, Dec. 19, 1986, as amended at 53 fined in § 318.300(b). FR 49848, Dec. 12, 1988] (iv) Incubation samples. (a) From each § 318.309 Finished product inspection. load of product processed in a batch- type thermal processing system (still (a) Finished product inspections shall or agitation), the establishment shall be handled under an approved quality select at least one container for incu- control program as provided in para- bation. graph (b) or paragraph (c) of this sec- (b) For continuous rotary retorts, hy- tion or shall be handled in accordance drostatic retorts, or other continuous- with paragraph (d) of this section. (b) Any partial quality control pro- type thermal processing systems, the gram for finished product inspection establishment shall select at least one shall be prepared and submitted to the container per 1,000 for incubation. Administrator for approval in accord- (c) Only normal-appearing containers ance with § 318.4 of this part. shall be selected for incubation. (c) That portion of a total quality (v) Incubation time. Canned product control system for finished product in- requiring incubation shall be incubated spection shall be prepared and submit- for not less than 10 days (240 hours) ted to the Administrator for approval under the conditions specified in para- in accordance with § 318.4 of this part. graph (d)(1)(ii) of this section. (d) Handling finished product inspec- (vi) Incubation checks and record main- tions without an approved quality con- tenance. Designated establishment em- trol program. ployees shall visually check all con- (1) Incubation of shelf stable canned tainers under incubation each working product—(i) Incubator. The establish- day and the inspector shall be notified ment shall provide incubation facilities when abnormal containers are de- which include an accurate tempera- tected. All abnormal containers should ture/time recording device, an indicat- be allowed to cool before a final deci- ing temperature device, a means for sion on their condition is made. For the circulation of the air inside the in- each incubation test the establishment cubator to prevent temperature vari- shall record at least the product name, ations, and a means to prevent unau- container size, container code, number thorized entry into the facility. The of containers incubated, in and out Program is responsible for the security dates, and incubation results. The es- of the incubator. tablishment shall retain such records, (ii) Incubation temperature. The incu- along with copies of the temperature/ bation temperature shall be main- time recording charts, in accordance tained at 95±5 °F (35±2.8 °C). If the incu- with § 318.307(e). bation temperature falls below 90 °F (or (vii) Abnormal containers. The finding 32 °C) or exceeds 100 °F (or 38 °C) but of abnormal containers (as defined in does not reach 103 °F (or 39.5 °C), the § 318.300(a)) among incubation samples

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is cause to officially retain at least the training supervisors of canning oper- code lot involved. ations. (viii) Shipping. No product shall be [51 FR 45619, Dec. 19, 1986] shipped from the establishment before the end of the required incubation pe- § 318.311 Recall procedure. riod except as provided in this para- Establishments shall prepare and graph or paragraph (b) or (c) of this maintain a current procedure for the section. An establishment wishing to recall of all canned product covered by ship product prior to the completion of this subpart. Upon request, the recall the required incubation period shall procedure shall be made available to submit a written proposal to the area Program employees for review. supervisor. Such a proposal shall include provisions that will assure that (Approved by the Office of Management and Budget under control number 0583–0015) shipped product will not reach the retail level of distribution before sample incubation is completed and that prod- PART 319—DEFINITIONS AND uct can be returned promptly to the es- STANDARDS OF IDENTITY OR tablishment should such action be COMPOSITION deemed necessary by the incubation test results. Upon receipt of written Subpart A—General approval from the area supervisor, Sec. product may be routinely shipped pro- 319.1 Labeling and preparation of standard- vided the establishment continues to ized products. comply with all requirements of this 319.2 Products and nitrates and nitrites. subpart. 319.5 Mechanically Separated (Species). (2) Container condition—(i) Normal 319.6 Limitations with respect to use of Me- containers. Only normal-appearing con- chanically Separated (Species). tainers shall be shipped from an estab- Subpart B—Raw Meat Products lishment as determined by an appropriate sampling plan or other means 319.15 Miscellaneous beef products. acceptable to Program employees. 319.29 Miscellaneous pork products. (ii) Abnormal containers. When abnor- Subpart C—Cooked Meats mal containers are detected by any means other than incubation, the es- 319.80 Barbecued meats. tablishment shall inform the inspector, 319.81 Roast beef parboiled and steam roast- and the affected code lot(s) shall not be ed. shipped until the Program has determined that the product is safe and sta- Subpart D—Cured Meats, Unsmoked and ble. Such a determination will take Smoked into account the cause and level of 319.100 Corned beef. abnormals in the affected lot(s) as well 319.101 Corned beef brisket. as any product disposition actions ei- 319.102 Corned beef round and other corned ther taken or proposed by the estab- beef cuts. lishment. 319.103 Cured beef tongue. 319.104 Cured pork products. (Approved by the Office of Management and 319.105 ‘‘Ham patties,’’ ‘‘Chopped ham,’’ Budget under control number 0583–0015) ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ and simi- [51 FR 45619, Dec. 19, 1986, as amended at 57 lar products. FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, 319.106 ‘‘Country Ham,’’ ‘‘Country Style 1992] Ham,’’ ‘‘Dry Cured Ham,’’ ‘‘Country Pork Shoulder,’’ ‘‘Country Style Pork Shoul- der,’’ and ‘‘Dry Cured Pork Shoulder.’’ § 318.310 Personnel and training. 319.107 Bacon. All operators of thermal processing systems specified in § 318.305 and con- Subpart E—Sausage Generally: Fresh tainer closure technicians shall be Sausage under the direct supervision of a person 319.140 Sausage. who has successfully completed a 319.141 Fresh pork sausage. school of instruction that is generally 319.142 Fresh beef sausage. recognized as adequate for properly 319.143 Breakfast sausage.

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319.144 Whole hog sausage. Subpart O—Meat Snacks, Hors d’Oeuvres, 319.145 Italian sausage products. Pizza, and Specialty Items Subpart F—Uncooked, Smoked Sausage 319.600 Pizza. 319.160 Smoked pork sausage. Subpart P—Fats, Oils, Shortenings Subpart G—Cooked Sausage 319.700 Margarine or oleomargarine. 319.701 Mixed fat shortening. 319.180 Frankfurters, frank, furter, hotdog, 319.702 Lard, leaf lard. weiner, vienna, bologna, garlic bologna, 319.703 Rendered animal fat or mixture knockwurst, and similar products. thereof. 319.181 Cheesefurters and similar products. 319.182 Braunschweiger and liver sausage or Subpart Q—Meat Soups, Soup Mixes, liverwurst. Broths, Stocks, Extracts

Subpart H [Reserved] 319.720 Meat extract. 319.721 Fluid extract of meat. Subpart I—Semi-Dry Fermented Sausage Subpart R—Meat Salads and Meat Spreads [Reserved] 319.760 Deviled ham, deviled tongue, and Subpart J—Dry Fermented Sausage similar products. [Reserved] 319.761 Potted meat food product and deviled meat food product. Subpart K—Luncheon Meat, Loaves and 319.762 Ham spread, tongue spread, and Jellied Products similar products. 319.260 Luncheon meat. Subpart S—Meat Baby Foods [Reserved] 319.261 Meat loaf. Subpart T—Dietetic Meat Foods [Reserved] Subpart L—Meat Specialties, Puddings and Nonspecific Loaves Subpart U—Miscellaneous 319.280 Scrapple. 319.880 Breaded products. 319.281 Bockwurst. 319.881 Liver meat food products. AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. Subpart M—Canned, Frozen, or 601–695; 7 CFR 2.17, 2.55. Dehydrated Meat Food Products SOURCE: 35 FR 15597, Oct. 3, 1970, unless otherwise noted. 319.300 Chili con carne. 319.301 Chili con carne with beans. 319.302 Hash. Subpart A—General 319.303 Corned beef hash. 319.304 Meat stews. § 319.1 Labeling and preparation of 319.305 Tamales. standardized products. 319.306 Spaghetti with meatballs and sauce, Labels for products for which stand- spaghetti with meat and sauce, and simi- ards of identity or composition are pre- lar products. scribed in this part shall show the ap- 319.307 Spaghetti sauce with meat. propriate product name, an ingredient 319.308 Tripe with milk. statement, and other label information 319.309 Beans with frankfurters in sauce, in accordance with the special provi- sauerkraut with wieners and juice, and similar products. sions, if any, in this part, and other- 319.310 Lima beans with ham in sauce, wise in accordance with the general la- beans with ham in sauce, beans with beling provisions in part 317 of this bacon in sauce, and similar products. subchapter, and such products shall be 319.311 Chow mein vegetables with meat, prepared in accordance with the special and chop suey vegetables with meat. provisions, if any, in this part and oth- 319.312 Pork with barbecue sauce and beef erwise in accordance with the general with barbecue sauce. provisions in this subchapter. Any 319.313 Beef with gravy and gravy with beef. product for which there is a common or usual name must consist of ingredients Subpart N—Meat Food Entree Products, and be prepared by the use of proce- Pies, and Turnovers dures common or usual to such prod- 319.500 Meat pies. ucts insofar as specific ingredients or

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procedures are not prescribed or pro- or PER requirements of this paragraph hibited by the provisions of this sub- shall only be used in producing animal chapter. fats. Where such product meets the bone particle size, calcium, and PER § 319.2 Products and nitrates and requirements of this paragraph, it may nitrites. also be used in the formulation of meat Any product, such as frankfurters food products in accordance with and corned beef, for which there is a § 319.6. standard in this part and to which ni- (b)–(d) [Reserved] trate or nitrite is permitted or required (e)(1) An essential amino acid con- to be added, may be prepared without nitrate or nitrite and labeled with such tent of at least 33 percent of the total standard name when immediately pre- amino acids presents in ‘‘Mechanically ceded with the term ‘‘Uncured’’ in the Separated (Species)’’ shall be accepted same size and style of lettering as the as evidence of compliance with the pro- rest of such standard name: Provided, tein quality requirement set forth in That the product is found by the Ad- paragraph (a) of this section. For pur- ministrator to be similar in size, fla- poses of this paragraph, essential vor, consistency, and general appear- amino acid content includes isoleucine, ance to such product as commonly pre- leucine, lysine, methionine, pared with nitrate and nitrite: And pro- phenylalanine, threonine, and valine vided further, That labeling for such content, and the total amino acids product complies with the provisions of present include isoleucine, leucine, ly- § 317.17(c) of this subchapter. sine, methionine, phenylalanine, threo- [44 FR 48961, Aug. 21, 1979] nine, valine, tyrosine, arginine, histi- dine, alanine, aspartic acid, glutamic § 319.5 Mechanically Separated (Spe- acid, glycine, proline, serine, and cies). hydroxyproline content. (a) Mechanically Separated (Species) (2) A prerequisite for label approval is any finely comminuted product re- for products consisting of or containing sulting from the mechanical separation ‘‘Mechanically Separated (Species)’’ is and removal of most of the bone from that such ‘‘Mechanically Separated attached skeletal muscle of livestock (Species)’’ shall have been produced by carcasses and parts of carcasses and an establishment under an approved meeting the other provisions of this plant quality control system. The Ad- paragraph. Examples of such product ministrator shall receive, evaluate, and are ‘‘Mechanically Separated Beef’’, approve requests for plant quality con- ‘‘Mechanically Separated Veal’’, ‘‘Me- trol in accordance with § 318.4(d)(1) and chanically Separated Pork’’, and ‘‘Me- (2) and (e) of this subchapter. Such a chanically Separated Lamb’’. At least plant quality control system shall pro- 98 percent of the bone particles present vide the controls and information nec- in such product shall have a maximum essary to assure that the product will size no greater than 0.5 millimeter in meet the requirements described in their greatest dimension and there shall be no bone particles larger than § 319.5(a) and to enable establishment 0.85 millimeter in their greatest dimen- personnel and program employees to sion. The product resulting from the monitor the system for effectiveness. separating process shall not have a cal- The system shall include a written de- cium content exceeding 0.75 percent, as scription of the methods used by the a measure of a bone solids content of establishment to maintain uniformity not more than 3 percent, and shall have of the raw ingredients used in manufac- a minimum PER of 2.5 (except as modi- turing product, to control the handling fied in paragraph (e)(1) of this section). and processing of the raw ingredients Such product also shall have a protein and the finished product, and shall con- content of not less than 14 percent and tain provisions for chemical analyses a fat content of not more than 30 per- of the product and other procedures to cent, or it shall be deemed to be prod- determine and assure compliance with uct for processing. Such product failing standards for the product. For purposes to meet the bone particle size, calcium, of this paragraph, a lot shall consist of

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the ‘‘Mechanically Separated (Spe- 1986 edition, sections 6.011–6.013, Re- cies)’’ designated as such by the opera- vised June 1987 (pages 6–35 through 6– tor of the establishment or his or her 65). The ‘‘Official Methods of Analysis agent from the product produced from of the Association of Official Analyt- a single species of livestock in no more ical Chemists,’’ 15th edition, 1990, is in- than one continuous shift of up to 12 corporated by reference with the ap- hours. All units of any lot must be proval of the Director of the Federal available for inspection by program Register in accordance with 5 U.S.C. employees. Analysis of a sample of at 552(a) and 1 CFR Part 51. Alternative least 1 pound from each lot to verify methods of analysis may be submitted contents of fat, protein, and calcium in to the Administrator to determine ‘‘Mechanically Separated (Species)’’ their acceptability based upon their ac- shall be performed by the operator of curacy, repeatability, reproducibility, the establishment or his or her agent and lowest level of reliable measure- to assure that finished product will ment, as demonstrated by at least 3 meet the requirements in § 319.5(a), ex- laboratories. Copies of AOAC’s ‘‘Offi- cept that such analyses with respect to cial Methods’’ may be obtained from: fat, protein, and calcium content shall AOAC, 2200 Wilson Boulevard, Suite be required to be performed with re- 400, Arlington, VA 22201. Copies of spect to only one randomly selected lot USDA’s Chemistry Laboratory Guide- of every five lots if the preceding ten book may be obtained from: Super- analyses and all such analyses per- intendent of Documents, Government formed by the Department during the Printing Office, Washington, DC 20402. preceding ten analyses period establish This incorporation by reference was ap- compliance with the requirements of proved by the Director of the FEDERAL § 319.5(a), and that no analyses with re- REGISTER on December 30, 1981 and spect to fat or protein content shall be March 15, 1982. These materials are in- required where the finished product is corporated as they exist on the date of represented as product for processing. the approval. A notice of any change in An analysis of a sample of at least 1 the sections of the AOAC methods or pound to verify essential amino acid the Chemistry Laboratory Guidebook content and/or protein efficiency ratio cited herein will be published in the in ‘‘Mechanically Separated (Species)’’ FEDERAL REGISTER.) The plant quality shall be performed by the operator of control system shall be subject to peri- the establishment or his or her agent odic review, and the approval of such at the rate of at least one per month system may be terminated in accord- during production to assure that finance with § 318.4(g)(2) of this sub- ished product will meet the require- chapter. ments of § 319.5(a), except that such analyses with respect to essential [47 FR 28256, June 29, 1982, as amended at 54 amino acid content and/or protein effi- FR 40631, Oct. 3, 1989; 59 FR 33642, June 30, ciency ratio shall be required to be per- 1994] formed only once every 6 months if the preceding three analyses and all such § 319.6 Limitations with respect to use analyses performed by the Department of Mechanically Separated (Spe- cies). during the preceding three analyses period establish compliance with the re- (a) Meat food products required to be quirements of § 319.5(a). Finished prod- prepared from one species shall not uct samples shall be analyzed in ac- contain Mechanically Separated (Spe- cordance with ‘‘Official Methods of cies) of any other species. Analysis of the Association of Official (b) Mechanically Separated (Species) Analytical Chemists,’’ (AOAC), 15th described in § 319.5 that has a protein edition, 1990, §§ 960.39, 976.21, 928.08 content of not less than 14 percent and (Chapter 39), and 940.33 (Chapter 45), a fat content of not more than 30 per- which is incorporated by reference, or cent may constitute up to 20 percent of if no AOAC method is available, in ac- the livestock and poultry product por- cordance with the ‘‘Chemistry Labora- tion of any meat food product except tory Guidebook,’’ U.S. Department of those listed in paragraph (d) of this Agriculture, Washington, DC, March section.

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(c) Mechanically Separated (Species) be used in the preparation of ham- for processing described in § 319.5 may burger only in accordance with the constitute up to 20 percent of the live- conditions prescribed in paragraph (a) stock and poultry product portion of of this section. any meat food product that is subject (c) Beef patties. ‘‘Beef Patties’’ shall to a definition and standard of identity consist of chopped fresh and/or frozen or composition in Part 319 which estab- beef with or without the addition of lishes a maximum limit on the fat con- beef fat as such and/or seasonings. tent of such meat food product except Binders or extenders, Mechanically those listed in paragraph (d) of this Separated (Species) used in accordance section. with § 319.6, and/or partially defatted (d) Mechanically Separated (Species) beef fatty tissue may be used without and Mechanically Separated (Species) added water or with added water only for processing described in § 319.5 shall in amounts such that the product char- not be used in baby, junior, or toddler acteristics are essentially that of a foods, ground beef, hamburger, fab- meat pattie. ricated steaks (§ 319.15 (a), (b), and (d)), (d) Fabricated steak. Fabricated beef barbecued meats (§ 319.80), roast beef- steaks, veal steaks, beef and veal parboiled and steam roasted (§ 319.81), steaks, or veal and beef steaks, and corned (cured) beef cuts (§§ 319.100— similar products, such as those labeled 319.103), certain cured pork products ‘‘Beef Steak, Chopped, Shaped, Fro- (§§ 319.104 (a)–(e) and 319.106), tripe with zen,’’ ‘‘Minute Steak, Formed, Wafer milk (§ 319.308), lima beans with ham Sliced, Frozen,’’ ‘‘Veal Steaks, Beef and similar products (§ 319.310), beef Added, Chopped—Molded—Cubed—Fro- with gravy and gravy with beef zen, Hydrolyzed Plant Protein, and (§ 319.313), and meat pies (§ 319.500). Flavoring’’ shall be prepared by comminuting and forming the product [47 FR 28257, June 29, 1982] from fresh and/or frozen meat, with or without added fat, of the species indi- Subpart B—Raw Meat Products cated on the label. Such products shall not contain more than 30 percent fat § 319.15 Miscellaneous beef products. and shall not contain added water, (a) Chopped beef, ground beef. binders or extenders. Beef cheek meat ‘‘Chopped Beef’’ or ‘‘Ground Beef’’ shall (trimmed beef cheeks) may be used in consist of chopped fresh and/or frozen the preparation of fabricated beef beef with or without seasoning and steaks only in accordance with the without the addition of beef fat as conditions prescribed in paragraph (a) such, shall not contain more than 30 of this section. percent fat, and shall not contain (e) Partially defatted beef fatty tissue. added water, phosphates, binders, or ‘‘Partially Defatted Beef Fatty Tissue’’ extenders. When beef cheek meat is a beef byproduct derived from the (trimmed beef cheeks) is used in the low temperature rendering (not exceed- preparation of chopped or ground beef, ing 120 °F.) of fresh beef fatty tissue. the amount of such cheek meat shall Such product shall have a pinkish color be limited to 25 percent; and if in ex- and a fresh odor and appearance. cess of natural proportions, its pres- [35 FR 15597, Oct. 3, 1970, as amended at 38 FR ence shall be declared on the label, in 29215, Oct. 23, 1973; 43 FR 26424, June 20, 1978; the ingredient statement required by 47 FR 10784, Mar. 12, 1982; 47 FR 28257, June § 317.2 of this subchapter, if any, and 29, 1982] otherwise contiguous to the name of the product. § 319.29 Miscellaneous pork products. (b) Hamburger. ‘‘Hamburger’’ shall (a) Partially defatted pork fatty tissue. consist of chopped fresh and/or frozen ‘‘Partially Defatted Pork Fatty Tis- beef with or without the addition of sue’’ is a pork byproduct derived from beef fat as such and/or seasoning, shall the low temperature rendering (not ex- not contain more than 30 percent fat, ceeding 120 °F.) of fresh pork fatty tis- and shall not contain added water, sue, exclusive of skin. Such product phosphates, binders, or extenders. Beef shall have a pinkish color and a fresh cheek meat (trimmed beef cheeks) may odor and appearance.

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Subpart C—Cooked Meats percent of the fresh beef weight. Corned beef other than canned shall be § 319.80 Barbecued meats. cured in pieces weighing not less than Barbecued meats, such as product la- 1 pound, and if cooked, its weight shall beled ‘‘Beef Barbecue’’ or ‘‘Barbecued not exceed the weight of the fresh Pork,’’ shall be cooked by the direct uncured beef. Beef cheek meat, beef action of dry heat resulting from the head meat and beef heart meat may be burning of hard wood or the hot coals used to the extent of 5 percent of the therefrom for a sufficient period to as- meat ingredient in preparation of this sume the usual characteristics of a bar- product when trimmed as specified in becued article, which include the for- § 319.81. When beef cheek meat, beef mation of a brown crust on the surface head meat, or beef heart meat is used and the rendering of surface fat. The in preparation of this product, its pres- product may be basted with a sauce ence shall be reflected in the statement of ingredients required by part 317 of during the cooking process. The weight this subchapter. The application of cur- of barbecued meat shall not exceed 70 ing solution to beef cuts, other than percent of the weight of the fresh briskets, which are intended for bulk uncooked meat. corned beef shall not result in an in- § 319.81 Roast beef parboiled and crease in the weight of the finished steam roasted. cured product of more than 10 percent over the weight of the fresh uncured ‘‘Roast Beef Parboiled and Steam meat. Roasted’’ shall be prepared so that the weight of the finished product, exclud- [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, ing salt and flavoring material, shall 1971, as amended at 38 FR 29215, Oct. 23, 1973] not exceed 70 percent of the fresh beef weight. Beef cheek meat and beef head § 319.101 Corned beef brisket. meat from which the overlying glan- In preparing ‘‘Corned Beef Brisket,’’ dular and connective tissues have been the application of curing solution to removed, and beef heart meat, exclu- the beef brisket shall not result in an sive of the heart cap may be used indi- increase in the weight of the finished vidually or collectively to the extent of cured product of more than 20 percent 5 percent of the meat ingredients in the over the weight of the fresh uncured preparation of canned product labeled brisket. If the product is cooked, the ‘‘Roast Beef Parboiled and Steam weight of the finished product shall not Roasted.’’ When beef cheek meat, beef exceed the weight of the fresh uncured head meat, or beef heart meat is used brisket. in the preparation of this product, its § 319.102 Corned beef round and other presence shall be reflected in the state- corned beef cuts. ment of ingredients required by part 317 of this subchapter. In preparing ‘‘Corned Beef Round’’ and other corned beef cuts, except [35 FR 15597, Oct. 3, 1970, as amended at 38 FR ‘‘Corned Beef Briskets,’’ the curing so- 29215, Oct. 23, 1973] lution shall be applied to pieces of beef weighing not less than one pound and Subpart D—Cured Meats, such application shall not result in an Unsmoked and Smoked increased weight of the cured beef product of more than 10 percent over § 319.100 Corned beef. the weight of the fresh uncured beef ‘‘Corned Beef’’ shall be prepared from cut. If the product is cooked, the beef briskets, navels, clods, middle weight of the finished product shall not ribs, rounds, rumps, or similar cuts exceed the weight of the fresh uncured using one or a combination of the cur- beef cut. ing ingredients specified in § 318.7(c) (1) and (4) of this subchapter. Canned prod- § 319.103 Cured beef tongue. uct labeled ‘‘Corned Beef’’ shall be pre- In preparing ‘‘Cured Beef Tongue,’’ pared so that the weight of the finished the application of curing solution to product, excluding cure, salt, and fla- the fresh beef tongue shall not result in voring material, shall not exceed 70 an increase in the weight of the cured

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beef tongue of more than 10 percent product name in lettering not less than over the weight of the fresh uncured 3⁄8 inch in height, or in lettering not beef tongue. less than one-third the size of the largest letter in the product name if it is in § 319.104 Cured pork products. the same color and style of print and (a) Cured pork products, including on the same color background as the hams, shoulders, picnics, butts and product name. However, the Adminis- loins, shall comply with the minimum trator may approve smaller lettering meat Protein Fat Free (PFF) percent- for labeling of packages of 1 pound or age requirements set forth in the fol- less, provided such lettering is at least lowing chart: one-third the size and of the same color and style as the product name. Minimum Type of cured meat PFF Product name and qualifying (c) Cured pork product prepared pur- pork product percent- statements suant to this section shall be subject to age1 the compliance procedures in § 318.19 of Cooked ham, 20.5 (Common and usual). this subchapter. loin2. (d) The binders provided in 18.5 (Common and usual) with nat- § 318.7(c)(4) of this subchapter for use in ural juices. 17.0 (Common and usual) water cured pork products may be used singly added. in those cured pork products labeled as <17.0 (Common and usual) and ‘‘Ham water added’’ and ‘‘Ham and water productÐX% of weight is added ingredi- water product—X% of weight is added ents.3 ingredients.’’ These binders are not Cooked shoul- 20.0 (Common and usual). permitted to be used in combination der, butt, pic- nic2. with one or more such binders ap- 18.0 (Common and usual) with nat- proved for use in cured pork products. ural juices. When any such substance is added to 16.5 (Common and usual) water these products, the substance shall be added. <16.5 (Common and usual) and designated in the ingredients state- water productÐX% of ment by its common or usual name in weight is added ingredi- order of predominance. ents.3 Uncooked cured 18.0 Uncooked (common and ham, loin. usual). [49 FR 14879, Apr. 13, 1984, as amended at 50 <18.0 Uncooked (common and FR 9792, Mar. 12, 1985; 53 FR 5151, Feb. 22, usual) and water productÐ 1988; 57 FR 42888, Sept. 17, 1992] X% of weight is added ingredients.3 § 319.105 ‘‘Ham patties,’’ ‘‘Chopped Uncooked cured 17.5 Uncooked (common and shoulder, butt, usual). ham,’’ ‘‘Pressed ham,’’ ‘‘Spiced ham,’’ picnic. and similar products. <17.5 Uncooked (common and (a) Finely divided (chopped, ground, usual) and water productÐ X% of weight is added in- flaked, chipped) cured ham products gredients.3 such as ‘‘Ham patties,’’ ‘‘Chopped 1 The minimum meat PFF percentage shall be the minimum ham,’’ ‘‘Pressed ham,’’ and ‘‘Spiced meat protein which is indigenous to the raw unprocessed pork ham’’ shall comply with minimum expressed as a percent of the non-fat portion of the finished product; and compliance shall be determined under § 318.19 meat Protein Fat Free (PFF) percent- of this subchapter for domestic cured pork product and age requirements set forth in the fol- § 327.23 of this subchapter for imported cured pork product. 2 The term ``cooked'' is not appropriate for use on labels of lowing chart: cured pork products heated only for the purpose of destruction of possible live trichinae. Product 3 Processors may immediately follow this qualifying state- Minimum Type of cured pork product meat PFF name and ment with a list of the ingredients in descending order of pre- 1 qualifying dominance rather than having the traditional ingredients state- percentage statements ment. In any case, the maximum percent of added substances in the finished product on a total weight percentage ``Ham Patties,'' ``Chopped basis would be inserted as the X value; e.g., Ham and Water ProductÐ20% of Weight is Added Ingredients. A prerequisite Ham,'' ``Pressed Ham,'' and for label approval of these products is a quality control pro- ``Spiced Ham'' ...... 19.5 (Common gram approved by the Administrator under § 318.4 of this sub- and usual). chapter. ``Ham Patties,'' ``Chopped Ham,'' ``Pressed Ham,'' and (b) Cured pork products for which ``Spiced Ham'' ...... 17.5 (Common there is a qualifying statement re- and usual) quired in paragraph (a) of this section with natural shall bear that statement as part of the juices. 323

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Style Pork Shoulder,’’ or ‘‘Dry Cured Minimum Product Type of cured pork product meat PFF name and Pork Shoulder.’’ are the uncooked, 1 qualifying percentage statements cured, dried, smoked or unsmoked meat food products made respectively ``Ham Patties,'' ``Chopped Ham,'' ``Pressed Ham,'' and from a single piece of meat conforming ``Spiced Ham'' ...... 16.0 (Common to the definition of ‘‘ham,’’ as specified and usual) in § 317.8(b)(13) of this subchapter, or water from a single piece of meat from a pork added. ``Ham Patties,'' ``Chopped shoulder. They are prepared in accord- Ham,'' ``Pressed Ham,'' and ance with paragraph (c) of this section ``Spiced Ham'' ...... <16.0 (Common by the dry application of salt (NaCl), or and usual) and water by the dry application of salt (NaCl) productÐ and one or more of the optional ingre- (x)% of dients as specified in paragraph (d) of weight is this section. They may not be injected added ingredients.2 with curing solutions nor placed in curing solutions. 1 The minimum meat PFF percentage shall be the minimum meat protein which is indigenous to the raw, (b) The product must be treated for unprocessed pork expressed as a percent of the nonfat the destruction of possible live portion of the finished product; and compliance shall be determined under section 318.19 of this subchapter. trichinae in accordance with such 2 Processors may immediately follow this qualifying methods as may be approved by the Ad- statement with a list of the ingredients in descending order of predominance rather than having the tradi- ministrator upon request in specific in- tional ingredients statement. In any case, the maximum stances and none of the provisions of percent of added substances in the finished product on a total weight percentage basis would be inserted as this standard can be interpreted as dis- the X value; e.g., Ham and Water Product—20% of charging trichinae treatment require- Weight is Added Ingredients. A prerequisite for label approval of these products is a quality control program ap- ments. proved by the Administrator under § 318.4 of this sub- (c)(1) The entire exterior of the ham chapter. or pork shoulder shall be coated by the (b) Cured pork products prepared dry application of salt or by the dry ap- under this section except ‘‘Ham pat- plication of salt combined with other ties’’ may contain finely chopped ham ingredients as permitted in paragraph shank meat to the extent of 25 percent (d) of this section. over that normally present in boneless (2) Additional salt, or salt mixed with ham. Mechanically Separated (Species) other permitted ingredients, may be re- Product may be used in accordance applied to the product as necessary to with § 319.6. insure complete penetration. (c) Cured pork product prepared pur- (3) When sodium or potassium ni- suant to this section shall be subject to trate, or sodium or potassium nitrite, the compliance procedures in § 318.19 of or a combination thereof, is used, the this subchapter, and those cured pork application of salt shall be in sufficient products prepared under this section quantity to insure that the finished for which there is a qualifying state- product has an internal salt content of ment required shall comply with the at least 4 percent. requirements of § 319.104(b) of this sub- (4) When no sodium nitrate, potas- chapter. sium nitrate, sodium nitrite, potas- (d) In addition to the other require- sium nitrite or a combination thereof ments of this section, ‘‘Ham Patties’’ is used, the application of salt shall be may not contain more than 35 percent in sufficient quantity to insure that fat, by analysis. the finished product has a brine con- [49 FR 14880, Apr. 13, 1984, as amended at 53 centration of not less than 10 percent FR 5151, Feb. 22, 1988] or a water activity of not more than 0.92. § 319.106 ‘‘Country Ham,’’ ‘‘Country (5) For hams or pork shoulders la- Style Ham,’’ ‘‘Dry Cured Ham,’’ beled ‘‘country’’ or ‘‘country style,’’ ‘‘Country Pork Shoulder,’’ ‘‘Country the combined period for curing and salt Style Pork Shoulder,’’ and ‘‘Dry equalization shall not be less than 45 Cured Pork Shoulder.’’ days for hams, and shall not be less (a) ‘‘Country Ham,’’ ‘‘Country Style than 25 days for pork shoulders; the Ham,’’ or ‘‘Dry Cured Ham,’’ and total time for curing salt equalization, ‘‘Country Pork Shoulder,’’ ‘‘Country 324

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and drying shall not be less than 70 Subpart E—Sausage Generally: days for hams, and shall not be less Fresh Sausage than 50 days for pork shoulders. During the drying and smoking period, the in- § 319.140 Sausage. ternal temperature of the product must Except as otherwise provided in this not exceed 95 °F., provided that such section, or under the Poultry Products temperature requirement shall not Inspection Act with respect to products apply to product dried or smoked under consisting partly of poultry, sausage is natural climatic conditions. the coarse or finely comminuted meat (6) For hams or pork shoulders la- food product prepared from one or beled ‘‘dry cured,’’ the combined period more kinds of meat or meat and meat for curing and salt equalization shall byproducts, containing various not be less than 45 days for hams, and amounts of water as provided for else- shall not be less than 25 days for pork where in this part, and usually sea- shoulders; and the total time for cur- soned with condimented proportions of ing, salt equalization, and drying shall condimental substances, and fre- not be less than 55 days for hams and quently cured. Certain sausage as pro- shall not be less than 40 days for pork vided for elsewhere in this part may shoulders. contain binders and extenders as provided in § 318.7(c)(4) of this subchapter. (7) The weight of the finished hams Sausage may not contain phosphates and pork shoulders covered in this sec- except that phosphates listed in tion shall be at least 18 percent less § 318.7(c)(4) of this subchapter may be than the fresh uncured weight of the used in cooked sausage. To facilitate article. chopping or mixing or to dissolve the (d) The optional ingredients for prod- usual curing ingredients, water or ice ucts covered in this section are: may be used in the preparation of sau- (1) Nutritive sweeteners, spices, sage which is not cooked in an amount seasonings and flavorings. not to exceed 3 percent of the total in- (2) Sodium or potassium nitrate and gredients in the formula. Cooked sau- sodium or potassium nitrite if used as sages such as Polish sausage, cotto sa- prescribed in this section and in ac- lami, braunschweiger, liver sausage, cordance with § 318.7(c)(4) of this sub- and similar cooked sausage products chapter. may contain no more than 10 percent of added water in the finished product. [42 FR 3299, Jan. 18, 1977] Sausage may contain Mechanically EFFECTIVE DATE NOTE: At 46 FR 1257, Jan. Separated (Species) used in accordance 6, 1981, the Department announced that the with § 319.6. temperature and time period provisions of [55 FR 34683, Aug. 24, 1990] § 319.106 (c)(5) and (c)(6) have not been in effect since November 17, 1980, and will not be § 319.141 Fresh pork sausage. enforced pending future Agency action in the matter. However, ham and pork shoulders ‘‘Fresh Pork Sausage’’ is sausage pre- must continue to be prepared in compliance pared with fresh pork or frozen pork or with all other provisions of § 319.106 in order both, but not including pork byprod- to be labeled ‘‘country ham,’’ ‘‘country style ucts, and may contain Mechanically ham,’’ or ‘‘dry cured ham,’’ and ‘‘country Separated (Species) in accordance with pork shoulder,’’ ‘‘country style pork shoul- § 319.6, and may be seasoned with der,’’ or ‘‘dry cured pork shoulder.’’ condimental substances as permitted under part 318 of this subchapter. The § 319.107 Bacon. finished product shall not contain more The weight of cured pork bellies than 50 percent fat. To facilitate chop- ready for slicing and labeling as ping or mixing, water or ice may be ‘‘Bacon’’ shall not exceed the weight of used in an amount not to exceed 3 per- the fresh uncured pork bellies. cent of the total ingredients used. [49 FR 14880, Apr. 13, 1984] [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26424, June 20, 1978; 47 FR 28257, 28258, June 29, 1982]

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§ 319.142 Fresh beef sausage. § 319.145 Italian sausage products. ‘‘Fresh Beef Sausage’’ is sausage pre- (a) Italian sausage products are cured pared with fresh beef or frozen beef, or or uncured sausages containing at least both, but not including beef byprod- 85 percent meat, or combination of ucts, and may contain Mechanically meat and fat, with the total fat con- Separated (Species) used in accordance tent constituting not more than 35 per- with § 319.6, and may be seasoned with cent of the finished product. Such prod- condimental substances as permitted ucts shall be prepared in accordance with the provisions of paragraph (a) (1), under part 318 of this subchapter. The (2) or (3) of this section, and shall con- finished product shall not contain more tain salt, pepper, and either fennel or than 30 percent fat. To facilitate chop- anise, or a combination of fennel and ping or mixing, water or ice may be anise. Such products may contain any used in an amount not to exceed 3 per- or all of the optional ingredients listed cent of the total ingredients used. in paragraph (b) of this section. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR (1) ‘‘Italian Sausage’’ shall be pre- 26424, June 20, 1978; 47 FR 28257, June 29, 1982] pared with fresh or frozen pork, or pork and pork fat, and may contain Me- § 319.143 Breakfast sausage. chanically Separated (Species) in accordance with § 319.6. ‘‘Breakfast sausage’’ is sausage pre- (2) ‘‘Italian Sausage with Beef,’’ pared with fresh and/or frozen meat; or ‘‘Italian Sausage with Veal,’’ or ‘‘Ital- fresh and/or frozen meat and meat by- ian Sausage with Beef and Veal,’’ shall products, and may contain Mechani- be prepared so that fresh or frozen pork cally Separated (Species) in accordance constitutes the major portion of the with § 319.6, and may be seasoned with meat content requirement of this para- condimental substances as permitted graph. Mechanically Separated (Spe- in part 318 of this subchapter. The fin- cies) may be used in accordance with ished product shall not contain more § 319.6. When pork muscle tissue is com- than 50 percent fat. To facilitate chop- bined with beef or veal, or both, in the ping or mixing, water or ice may be preparation of bulk-packed products, used in an amount not to exceed 3 per- or patties, it shall be treated for the cent of the total ingredients used. destruction of possible live trichinae in Binders or extenders may be added as accordance with § 318.10 of this sub- provided in § 318.7(c)(4) of this subchapter. chapter. (3) ‘‘Italian Beef Sausage’’ or ‘‘Kosher Italian Beef Sausage’’ shall be prepared [55 FR 34683, Aug. 24, 1990] with fresh or frozen beef or beef and beef fat. ‘‘Italian Veal Sausage’’ or § 319.144 Whole hog sausage. ‘‘Kosher Italian Veal Sausage’’ shall be ‘‘Whole Hog Sausage’’ is sausage pre- prepared with fresh or frozen veal or pared with fresh and/or frozen meat veal and veal fat. Mechanically Sepa- from swine in such proportions as are rated (Species) may be used in accord- normal to a single animal, and may in- ance with § 319.6. clude any Mechanically Separated (4) Italian sausage products made in (Species) produced from the animal and conformance with the provisions of used in accordance with § 319.6, and paragraphs (a) (1), (2), and (3) of this may be seasoned with condimental subsection, and with paragraphs (b) and (c) stances as permitted under part 318 of of this section, may contain sodium nitrite or potassium nitrite in amounts this subchapter. The finished product not to exceed those allowed in the shall not contain more than 50 percent chart following § 318.7(c)(4), provided fat. To facilitate chopping or mixing, that such products are labeled with the water or ice may be used in an amount word ‘‘cured’’ in the product name, not to exceed 3 percent of the total in- such as ‘‘Cured Italian Sausage.’’ The gredients used. word ‘‘cured’’ shall be displayed on the [35 FR 15597, Oct. 3, 1970, as amended at 43 FR product label in the same size and style 26424, June 20, 1978; 47 FR 28257, 28258, June of lettering as other words in the prod- 29, 1982] uct name.

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(b) Optional ingredients permitted in not to exceed 3 percent of the total in- Italian sausage products include: gredients used. (1) Spices (including paprika) and [35 FR 15597, Oct. 3, 1970, as amended at 47 FR flavorings. 28258, June 29, 1982] (2) Water or ice to facilitate chopping or mixing, but not to exceed 3 percent Subpart G—Cooked Sausage of the total weight of all ingredients including the water. § 319.180 Frankfurter, frank, furter, (3) Red or green peppers, or both. hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and (4) Dehydrated or fresh onions, gar- similar products. lic, and parsley. (a) Frankfurter, frank, furter, hot- (5) Sugar, dextrose, corn syrup, corn dog, wiener, vienna, bologna, garlic bo- syrup solids, and glucose syrup. logna, knockwurst and similar cooked (6) Monosodium glutamate and anti- sausages are comminuted, semisolid oxidants in accordance with the chart sausages prepared from one or more of substances in § 318.7(c)(4) of this sub- kinds of raw skeletal muscle meat or chapter. raw skeletal muscle meat and raw or (c) If Italian sausage products are cooked poultry meat, and seasoned and cooked or smoked, determination of cured, using one or more of the curing compliance with the provisions of para- agents in accordance with § 318.7(c) of graphs (a) and (b) of this section shall this chapter. They may or may not be be based on the uncooked or unsmoked smoked. The finished products shall product. The product before cooking or not contain more than 30 percent fat. smoking shall contain no more than 3 Water or ice, or both, may be used to percent water as specified in paragraph facilitate chopping or mixing or to dis- (b)(2) of this section. Product which is solve the curing ingredients but the cooked shall be labeled with the word sausage shall contain no more than 40 percent of a combination of fat and ‘‘cooked’’ in the product name, such as added water. These sausage products ‘‘Cooked Italian Sausage’’ or ‘‘Cooked may contain only phosphates approved Cured Italian Sausage.’’ Product which under Part 318 of this chapter. Such is smoked shall be labeled with the products may contain raw or cooked word ‘‘smoked’’ in the product name, poultry meat and/or Mechanically Sep- such as ‘‘Smoked Italian Sausage’’ or arated (Kind of Poultry) without skin ‘‘Smoked Cured Italian Sausage.’’ The and without kidneys and sex glands words ‘‘cooked’’ and ‘‘smoked’’ shall be used in accordance with § 381.174, not in displayed on the product label in the excess of 15 percent of the total ingre- same size and style of lettering as dients, excluding water, in the sausage, other words in the product name. and Mechanically Separated (Species) used in accordance with § 319.6. Such [41 FR 2630, Jan. 19, 1976, as amended at 43 FR 26424, June 20, 1978; 47 FR 28257, 28258, poultry meat ingredients shall be des- June 29, 1982; 49 FR 46533, Nov. 27, 1984] ignated in the ingredient statement on the label of such sausage in accordance with the provisions of § 381.118 of this Subpart F—Uncooked, Smoked chapter. Sausage (b) Frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bo- § 319.160 Smoked pork sausage. logna, knockwurst and similar cooked ‘‘Smoked Pork Sausage’’ is pork sau- sausages that are labeled with the sage that is smoked with hardwood or phrase ‘‘with byproducts’’ or ‘‘with va- other approved nonresinous materials. riety meats’’ in the product name are It may be seasoned with condimental comminuted, semisolid sausages con- substances as permitted in Part 318 of sisting of not less than 15 percent of this subchapter. The finished product one or more kinds of raw skeletal mus- shall not contain more than 50 percent cle meat with raw meat byproducts, or fat. To facilitate chopping or mixing, not less than 15 percent of one or more kinds of raw skeletal muscle meat with water, or ice may be used in an amount raw meat byproducts and raw or

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cooked poultry products; and seasoned such sausage products are prepared in and cured, using one or more of the part with Mechanically Separated curing ingredients in accordance with (Species) in accordance with § 319.6, § 318.7(c) of this chapter. They may or they shall be labeled in accordance may not be smoked. Partially defatted with § 317.2(j)(13) of this subchapter. pork fatty tissue or partially defatted (d) A cooked sausage as defined in beef fatty tissue, or a combination of paragraph (b) of this section shall be both, may be used in an amount not ex- labeled by its generic name, e.g., frank- ceeding 15 percent of the meat and furter, frank, furter, hotdog, wiener, meat byproducts or meat, meat by- vienna, bologna, garlic bologna, or products, and poultry products ingredi- knockwurst, in conjunction with the ents. The finished products shall not phrase ‘‘with byproducts’’ or ‘‘with va- contain more than 30 percent fat. Water or ice, or both, may be used to riety meats’’ with such supplemental facilitate chopping or mixing to dis- phrase shown in a prominent manner solve the curing and seasoning ingredi- directly contiguous to the generic ents, the sausage shall contain no more name and in the same color on an iden- than 40 percent of a combination of fat tical background. and added water. These sausage prod- (e) One or more of the binders and ex- ucts may contain only phosphates ap- tenders as provided in § 318.7(c)(4) of proved under Part 318 of this chapter. this subchapter may be used in cooked These sausage products may contain sausage otherwise complying with poultry products and/or Mechanically paragraph (a) or (b) of this section. Separated (Kind of Poultry) used in ac- When any such substance is added to cordance with § 381.174, individually or these products, the substance shall be in combination, not in excess of 15 per- designated in the ingredients state- cent of the total ingredients, excluding ment by its common or usual name in water, in the sausage, and may contain order of predominance. Mechanically Separated (Species) used (f) Cooked sausages shall not be la- in accordance with § 319.6. Such poultry beled with terms such as ‘‘All Meat’’ or products shall not contain kidneys or ‘‘All (Species),’’ or otherwise to indi- sex glands. The amount of poultry skin cate they do not contain nonmeat in- present in the sausage must not exceed gredients or are prepared only from the natural proportion of skin present meat. on the whole carcass of the kind of (g) For the purposes of this section: poultry used in the sausage, as speci- Poultry meat means deboned chicken fied in § 381.117(d) of this chapter. The poultry products used in the sausage meat or turkey meat, or both, without shall be designated in the ingredient skin or added fat; poultry products statement on the label of such sausage mean chicken or turkey, or chicken in accordance with the provisions of meat or turkey meat as defined in § 381.118 of this chapter. Meat byprod- § 381.118 of this chapter, or poultry by- ucts used in the sausage shall be des- products as defined in § 381.1 of this ignated individually in the ingredient chapter; and meat byproducts (or vari- statement on the label for such sausage ety meats), mean pork stomachs or in accordance with § 317.2 of this chap- snouts; beef, veal, lamb, or goat tripe; ter. beef, veal, lamb, goat, or pork hearts, (c) A cooked sausage as defined in tongues, fat, lips, weasands, and paragraph (a) of this section shall be spleens; and partially defatted pork labeled by its generic name, e.g., frank- fatty tissue, or partially defatted beef furter, frank, furter, hotdog, wiener, fatty tissue. vienna, bologna, garlic bologna, or knockwurst. When such sausage prod- [38 FR 14742, June 5, 1973; 38 FR 22621, Aug. 23, 1973; 38 FR 24640, Sept. 10, 1973, as amend- ucts are prepared with meat from a sin- ed at 43 FR 26424, June 20, 1978; 45 FR 10318, gle species of cattle, sheep, swine, or Feb. 15, 1980; 47 FR 10784, Mar. 12, 1982; 47 FR goats they shall be labeled with the 26374, June 18, 1982; 47 FR 28257, June 29, 1982; term designating the particular species 53 FR 8428, Mar. 15, 1988; 55 FR 34683, Aug. 24, in conjunction with the generic name, 1990; 56 FR 41448, Aug. 21, 1991; 60 FR 55982, e.g., ‘‘Beef Frankfurter,’’ and when Nov. 3, 1995]

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§ 319.181 Cheesefurters and similar with § 319.6. Binders and extenders products. maybe used as permitted in § 319.140. If ‘‘Cheesefurters’’ and similar products prepared from components of a single are products in casings which resemble species, the product name may reflect frankfurters except that they contain that species, e.g., ‘‘Pork Liver Sau- sufficient cheese to give definite char- sage.’’ acteristics to the finished article. They [47 FR 36108, Aug. 19, 1982] may contain binders and extenders as provided in § 318.7(c)(4) of this subchapter. Limits on use as provided in Subpart H [Reserved] § 318.7 are intended to be exclusive of the cheese constituent. When any such Subpart I—Semi-Dry Fermented substance is added to these products, Sausage [Reserved] the substance shall be designated in the ingredients statement by its com- Subpart J—Dry Fermented mon or usual name in order of predominance. These products shall contain no Sausage [Reserved] more than 40 percent of a combination of fat and added water, and no more Subpart K—Luncheon Meat, than 30 percent fat and shall comply Loaves and Jellied Products with the other provisions for cooked sausages that are in this subchapter. § 319.260 Luncheon meat. [55 FR 34683, Aug. 24, 1990, as amended at 56 ‘‘Luncheon Meat’’ is a cured, cooked FR 41448, Aug. 21, 1991] meat food product made from comminuted meat. Mechanically Sepa- § 319.182 Braunschweiger and liver rated (Species) may be used in accord- sausage or liverwurst. ance with § 319.6. To facilitate chopping (a) ‘‘Braunschweiger’’ is a cooked or mixing or to dissolve the usual cur- sausage made from fresh, cured, and/or ing ingredients, water or ice may be frozen pork, beef, and/or veal and at used in the preparation of luncheon least 30 percent pork, beef, and/or veal meat in an amount not to exceed 3 per- livers computed on the weight of the cent of the total ingredients. fresh livers. It may also contain pork and/or beef fat. Mechanically Sepa- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] rated (Species) may be used in accordance with § 319.6. Binders and extenders § 319.261 Meat loaf. may be used as permitted in § 319.140. The product may have a smoked taste ‘‘Meat Loaf’’ is a cooked meat food characteristic, which may be imparted product in loaf form made from by use of smoked meats, smoke flavor- comminuted meat. Mechanically Sepa- ing or smoking. If prepared from com- rated (Species) may be used in accord- ponents of a single species, the product ance with § 319.6. To facilitate chopping name may reflect the species, e.g., or mixing, water or ice may be used in ‘‘Beef Braunschweiger.’’ Braun- an amount not to exceed 3 percent of schweiger may also be labeled as any of the total ingredients used. the following: ‘‘Braunschweiger—A [35 FR 15597, Oct. 3, 1970, as amended at 43 FR Liver Sausage,’’ ‘‘Braunschweiger—A 26425, June 20, 1978; 47 FR 28257, June 29, 1982] Liverwurst,’’ or ‘‘Braunschweiger (Liver Sausage)’’ or ‘‘Braunschweiger (Liverwurst).’’ Subpart L—Meat Specialties, (b) ‘‘Liver Sausage’’ or ‘‘Liverwurst’’ Puddings and Nonspecific Loaves is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or § 319.280 Scrapple. veal and at least 30 percent pork, beef, ‘‘Scrapple’’ shall contain not less veal, sheep, and/or goat livers com- than 40 percent meat and/or meat by- puted on the weight of the fresh livers. products computed on the basis of the It may also contain pork and/or beef fresh weight, exclusive of bone. Me- byproducts. Mechanically Separated chanically Separated (Species) may be (Species) may be used in accordance used in accordance with § 319.6. The

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meal or flour used may be derived from (8) Sugars (sucrose and dextrose). grain and/or soybeans. (9) Binders and extenders may be added as provided in § 318.7(c)(4) of this [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] subchapter. When any such substance is added to bockwurst, the substance § 319.281 Bockwurst. shall be designated in the ingredients (a) Bockwurst is an uncured, statement by its common or usual comminuted meat food product which name in order of predominance. may or may not be cooked. It contains (c) If bockwurst is cooked or par- meat, milk or water or a combination tially cooked, the composition of the thereof, eggs, vegetables, and any of raw mix from which it is prepared shall the optional ingredients listed in para- be used in determining whether it graph (b) of this section; and is pre- meets the requirements of this section. pared in accordance with the provi- [40 FR 18542, Apr. 29, 1975, as amended at 41 sions of paragraphs (a)(1), (2), (3), and FR 18089, Apr. 30, 1976; 43 FR 26425, June 20, (4) of this section. 1978; 45 FR 10318, Feb. 15, 1980; 47 FR 26374, (1) Meat shall constitute not less June 18, 1982; 47 FR 28257, 28258, June 29, 1982; than 70 percent of the total weight of 55 FR 34683, Aug. 24, 1990; 56 FR 41448, Aug. 21, 1991] the product and shall consist of pork or a mixture of pork and veal, pork and beef, or pork, veal, and beef. Such meat Subpart M—Canned, Frozen, or shall be fresh or fresh frozen meat. Dehydrated Meat Food Products Pork may be omitted when the specie § 319.300 Chili con carne. or species of meat used in the product is identified in the product name (e.g., ‘‘Chili con carne’’ shall contain not Veal Bockwurst, Beef Bockwurst, or less than 40 percent of meat computed Beef and Veal Bockwurst). Mechani- on the weight of the fresh meat. Me- cally Separated (Species) may be used chanically Separated (Species) may be in accordance with § 319.6. used in accordance with § 319.6. Head (2) The ‘‘milk’’ may be fresh whole meat, cheek meat, and heart meat ex- milk, dried milk, nonfat dry milk, cal- clusive of the heart cap may be used to cium reduced dried skim milk, enzyme the extent of 25 percent of the meat in- (rennet) treated calcium reduced dried gredients under specific declaration on skim milk and calcium lactate, or any the label. The mixture may contain combination thereof. binders and extenders as provided in (3) ‘‘Eggs’’ refer to whole eggs that § 318.7(c)(4) of this subchapter. are fresh, frozen, or dried. [55 FR 34684, Aug. 24, 1990] (4) ‘‘Vegetables’’ refer to onions, chives, parsley, and leeks, alone or in § 319.301 Chili con carne with beans. any combination. Chili con carne with beans shall con- (b) Bockwurst may contain one or tain not less than 25 percent of meat more of the following optional ingredi- computed on the weight of the fresh ents: meat. Mechanically Separated (Spe- (1) Pork fat. cies) may be used in accordance with (2) Celery, fresh or dehydrated. § 319.6. Head meat, cheek meat, or heart (3) Spices, flavorings. meat exclusive of the heart cap may be (4) Salt. used to the extent of 25 percent of the (5) Egg whites, fresh, frozen, or dried. meat ingredients, and its presence (6) Corn syrup solids, corn syrup, or shall be reflected in the statement of glucose syrup with a maximum limit of ingredients required by part 317 of this 2 percent individually or collectively, subchapter. The mixture may contain calculated on a dry basis. The maxi- binders and extenders as provided in mum quantities of such ingredients § 318.7(c)(4) of this subchapter. shall be computed on the basis of the total weight of the ingredients. [55 FR 34684, Aug. 24, 1990] (7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein § 319.302 Hash. hydrolysate, and monosodium glu- ‘‘Hash’’ shall contain not less than 35 tamate. percent of meat computed on the

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weight of the cooked and trimmed vidually or collectively to the extent of meat. The weight of the cooked meat 5 percent of the meat ingredients; used in this calculation shall not ex- (2) Onions, including fresh onions, de- ceed 70 percent of the weight of the hydrated onions, or onion powder; uncooked fresh meat. Mechanically (3) Garlic, including fresh garlic, de- Separated (Species) may be used in ac- hydrated garlic, or garlic powder; cordance with § 319.6. (4) Water; (5) Beef broth or beef stock; [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982] (6) Monosodium glutamate; (7) Hydrolyzed plant protein; § 319.303 Corned beef hash. (8) Beef fat; (9) Mechanically Separated (Species) (a) ‘‘Corned Beef Hash’’ is the semi- when derived from carcasses of cattle solid food product in the form of a com- may be used in accordance with § 319.6. pact mass which is prepared with beef, (c) The finished product shall not potatoes, curing agents, seasonings, contain more than 15 percent fat nor and any of the optional ingredients more than 72 percent moisture. listed in paragraph (b) of this section, (d)(1) When any ingredient specified in accordance with the provisions of in paragraph (b)(1) of this section is paragraphs (a) (1), (2), (3) and (4) of this used, the label shall bear the following section and the provisions of paragraph applicable statement: ‘‘Beef cheek (c) of this section. meat constitutes 5 percent of the meat (1) Either fresh beef, cured beef, or ingredient,’’ or ‘‘Beef head meat con- canned corned beef or a mixture of two stitutes 5 percent of the meat ingredi- or more of these ingredients, may be ent,’’ or ‘‘Beef heart meat constitutes 5 used, and the finished product shall percent of the meat ingredient.’’ When contain not less than 35 percent of beef two or more of the ingredients are computed on the weight of the cooked used, the words ‘‘Constitutes 5 percent and trimmed beef. The weight of the of meat ingredient’’ need only appear cooked meat used in this calculation once. shall not exceed 70 percent of the (2) Whenever the words ‘‘corned beef weight of the uncooked fresh meat. hash’’ are featured on the label so con- (2) ‘‘Potatoes’’ refers to fresh pota- spicuously as to identify the contents, toes, dehydrated potatoes, cooked de- the statements prescribed in paragraph hydrated potatoes, or a mixture of two (d)(1) of this section shall immediately or more of these ingredients. and conspicuously precede or follow (3) The curing agents that may be such name without intervening writ- used are salt, sodium nitrate, sodium ten, printed, or other graphic matter. nitrite, potassium nitrate, or potassium nitrite, or a combination of two [35 FR 15597, Oct. 3, 1970, as amended at 43 FR or more of these ingredients. When so- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] dium nitrate, or sodium nitrite, potas- § 319.304 Meat stews. sium nitrate, or potassium nitrite is used it shall be used in amounts not ex- Meat stews such as ‘‘Beef Stew’’ or ceeding those specified in § 318.7 (c)(4) ‘‘Lamb Stew’’ shall contain not less of this subchapter. than 25 percent of meat of the species (4) The seasonings that may be used, named on the label, computed on the singly or in combination, are salt, weight of the fresh meat. Mechanically sugar (sucrose or dextrose), spice, and Separated (Species) may be used in ac- flavoring, including essential oils, cordance with § 319.6. oleoresins, and other spice extractives. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR (b) Corned beef hash may contain one 26425, June 20, 1978; 47 FR 28257, June 29, 1982] or more of the following optional ingredients: § 319.305 Tamales. (1) Beef cheek meat and beef head ‘‘Tamales’’ shall be prepared with at meat from which the overlying glan- least 25 percent meat computed on the dular and connective tissues have been weight of the uncooked fresh meat in removed, and beef heart meat, exclu- relation to all ingredients of the sive of the heart cap, may be used indi- tamales. When tamales are packed in

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sauce or gravy, the name of the prod- § 319.309 Beans with frankfurters in uct shall include a prominent reference sauce, sauerkraut with wieners and to the sauce or gravy; for example, juice, and similar products. ‘‘Tamales With Sauce’’ or ‘‘Tamales ‘‘Beans with Frankfurters in Sauce,’’ With Gravy.’’ Product labeled ‘‘Sauerkraut with Wieners and Juice,’’ ‘‘Tamales With Sauce’’ or ‘‘Tamales and similar products shall contain not With Gravy’’ shall contain not less less than 20 percent frankfurters or than 20 percent meat, computed on the wieners computed on the weight of the weight of the uncooked fresh meat in smoked and cooked sausage prior to its relation to the total ingredients mak- inclusion with the beans or sauerkraut. ing up the tamales and sauce or the tamales and gravy. Mechanically Sepa- § 319.310 Lima beans with ham in rated (Species) may be used in accord- sauce, beans with ham in sauce, ance with § 319.6. beans with bacon in sauce, and similar products. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR ‘‘Lima Beans with Ham in Sauce,’’ 26425, June 20, 1978; 47 FR 28257, 28258, June ‘‘Beans with Ham in Sauce,’’ ‘‘Beans 29, 1982] with Bacon in Sauce,’’ and similar § 319.306 Spaghetti with meatballs and products shall contain not less than 12 sauce, spaghetti with meat and percent ham or bacon computed on the sauce, and similar products. weight of the smoked ham or bacon prior to its inclusion with the beans ‘‘Spaghetti with Meatballs and and sauce. Sauce’’ and ‘‘Spaghetti with Meat and Sauce,’’ and similar products shall con- § 319.311 Chow mein vegetables with tain not less than 12 percent of meat meat, and chop suey vegetables computed on the weight of the fresh with meat. meat. Mechanically Separated (Spe- ‘‘Chow Mein Vegetables with Meat’’ cies) may be used in accordance with and ‘‘Chop Suey Vegetables with Meat’’ § 319.6. The presence of the sauce or shall contain not less than 12 percent gravy constituent shall be declared meat computed on the weight of the prominently on the label as part of the uncooked fresh meat prior to its inclu- name of the product. Meatballs may be sion with the other ingredients. Me- prepared with farinaceous material and chanically Separated (Species) may be with other binders and extenders as used in accordance with § 319.6. provided in § 318.7(c)(4) of this subchapter. [35 FR 15597, Oct. 3, 1970; 36 FR 11903, June 23, 1971, as amended at 43 FR 26425, June 20, 1978; [55 FR 34684, Aug. 24, 1990] 47 FR 28257, June 29, 1982]

§ 319.307 Spaghetti sauce with meat. § 319.312 Pork with barbecue sauce and beef with barbecue sauce. ‘‘Spaghetti Sauce with Meat’’ shall contain not less than 6 percent of meat ‘‘Pork with Barbecue Sauce’’ and computed on the weight of the fresh ‘‘Beef with Barbecue Sauce’’ shall con- meat. Mechanically Separated (Spe- tain not less than 50 percent meat of cies) may be used in accordance with the species specified on the label, com- § 319.6. puted on the weight of the cooked and trimmed meat. Mechanically Sepa- [35 FR 15597, Oct. 3, 1970, as amended at 43 FR rated (Species) may be used in accord- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] ance with § 319.6. The weight of the cooked meat used in this calculation § 319.308 Tripe with milk. shall not exceed 70 percent of the ‘‘Tripe with Milk’’ shall be prepared uncooked weight of the meat. If so that the finished canned article, ex- uncooked meat is used in formulating clusive of the cooked-out juices and the products, they shall contain at milk, will contain at least 65 percent least 72 percent meat computed on the tripe. The product shall be prepared weight of the fresh uncooked meat. with not less than 10 percent milk. [51 FR 32059, Sept. 9, 1986]

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§ 319.313 Beef with gravy and gravy under § 938.06 (Chapter 33) of the ‘‘Indi- with beef. rect Methods’’ in ‘‘Official Methods of ‘‘Beef with Gravy’’ and ‘‘Gravy with Analysis of the Association of Official Beef’’ shall not be made with beef Analytical Chemists’’, 15th edition, which, in the aggregate for each lot 1990.2 The ‘‘Official Methods of Analy- contains more than 30 percent sis of the Association of Official Ana- trimmable fat, that is, fat which can be lytical Chemists,’’ 15th edition, 1990, is removed by thorough, practicable trim- incorporated by reference with the ap- ming and sorting. proval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It is produced Subpart N—Meat Food Entree from one or more of the ingredients Products, Pies, and Turnovers designated in paragraph (a)(1) of this section, and one or more of the ingredi- § 319.500 Meat pies. ents designated in paragraph (a)(2) of Meat pies such as ‘‘Beef Pie,’’ ‘‘Veal this section, to which may be added Pie,’’ and ‘‘Pork Pie’’ shall contain one or more of the optional ingredients meat of the species specified on the designated in paragraph (b) of this sec- label, in an amount not less than 25 tion. Margarine or oleomargarine con- percent of all ingredients including tains Vitamin A as provided for in crust and shall be computed on the paragraph (a)(3) of this section. basis of the fresh uncooked meat. (1) Edible fats and oils or mixtures of these, whose origin is vegetable or ren- Subpart O—Meat Snacks, Hors dered animal fats from cattle, sheep, d’Oeuvres, Pizza, and Spe- swine or goats. cialty Items (2)(i) Water; milk; milk products including, but not limited to, the liquid, § 319.600 Pizza. condensed, or dry form of whey, re- (a) ‘‘Pizza with Meat’’ is a bread base duced lactose whey, reduced minerals meat food product with tomato sauce, whey, or whey protein concentrate, cheese, and meat topping. It shall con- non-lactose-containing whey compo- tain cooked meat made from not less nents, casein, or caseinate; or other than 15 percent raw meat. Mechani- suitable edible protein, including albu- cally Separated (Species) may be used min, vegetable proteins, or soy protein in accordance with § 319.6. isolate; or any mixture of two or more (b) ‘‘Pizza with Sausage’’ is a bread of the articles designated in this sub- base meat food product with tomato paragraph, in amounts not greater sauce, cheese, and not less than 12 per- than reasonably required to accomplish cent cooked sausage or 10 percent dry the desired effect. sausage; e.g., pepperoni. Mechanically (ii) The articles designated in this Separated (Species) may be used in ac- subparagraph shall be pasteurized and cordance with § 319.6. then may be subjected to the action of harmless bacterial starters. One or [35 FR 15597, Oct. 3, 1970, as amended at 43 FR more of the articles designated in this 26425, June 20, 1978; 47 FR 28257, June 29, 1982] subparagraph is intimately mixed with the edible fat or oil ingredients, or Subpart P—Fats, Oils, Shortenings both, to form a solidified or liquid emulsion. § 319.700 Margarine or oleomargarine.1 (3) Vitamin A in such quantity that (a) Margarine or oleomargarine is the the finished margarine or oleo- food in plastic form or liquid emulsion, margarine contains not less than 15,000 containing not less than 80 percent fat determined by the method prescribed 2 A copy of the ‘‘Official Methods of Analy- sis of the Association of Official Analytical 1 Insofar as the standard contains provi- Chemists,’’ 15th edition, 1990, is on file with sions relating to margarine or oleomargarine the Director, Office of the Federal Register, which does not contain any meat food prod- and may be purchased from the Association ucts, such provisions merely reflect the ap- of Official Analytical Chemists, Inc., 2200 plicable standard under the Federal Food, Wilson Boulevard, Suite 400, Arlington, Vir- Drug, and Cosmetic Act. ginia 22201.

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International Units (IU) of ViTamin A of this subparagraph, provitamine A per pound or 33,000 IU per kilogram. (beta-carotene) shall also be deemed to (b)(1) Vitamin D in such quantity be a coloring agent. that the finished margarine or oleo- (8) Flavoring substances in amounts margarine contains not less than 1,500 sufficient for purpose. IU of Vitamin D per pound or 3,300 IU (9) Acidulants identified in per kilogram. § 318.7(c)(4) of this chapter, in amounts (2) Salt (sodium chloride); or potas- sufficient for purpose: adipic acid; cit- sium chloride for dietary margarine or ric and lactic acids and their potassium oleomargarine. and sodium salts; phosphoric acid; L- (3) Nutritive carbohydrate sweeten- tartaric acid and its sodium and so- ers. dium-potassium salts; and hydrochloric (4) Emulsifiers identified in acid. § 318.7(c)(4) of this chapter, within these (10) Alkalizers identified in maximum amounts in percent by § 318.7(c)(4) of this chapter, in amounts weight of the finished food: Mono- and sufficient for purpose: potassium bicar- diglycerides of fatty acids esterified bonate, potassium carbonate, sodium with any or all of the following acids: bicarbonate, sodium carbonate, and so- acetic, acetyltartaric, citric, lactic, dium hydroxide. tartaric, and their sodium and calcium (11) For the purposes of this section, salts, 0.5 percent; such mono- and the term ‘‘milk’’ unqualified means diglycerides in combination with the milk from cows. If any milk other than sodium sulfoacetate derivatives there- cow’s milk is used in whole or in part, of, 0.5 percent; polyglycerol esters of the animal source shall be identified in fatty acids, 0.5 percent; 1,2-propylene conjunction with the word ‘‘milk’’ in glycol esters of fatty acids, 2 percent; the ingredient statement. lecithin, 0.5 percent. [48 FR 52697, Nov. 22, 1983, as amended at 50 (5) Preservatives identified in FR 3739, Jan. 28, 1985; 54 FR 40632, Oct. 3, 1989; § 318.7(c)(4) of this chapter, within these 59 FR 33642, June 30, 1994] maximum amounts in percent by weight of the finished food: Sorbic § 319.701 Mixed fat shortening. acid, benzoic acid and their sodium, po- Shortening prepared with a mixture tassium, and calcium salts, individ- of meat fats and vegetable oils may be ually, 0.1 percent, or in combination, identified either as ‘‘Shortening Pre- 0.2 percent, expressed as the acids; cal- pared with Meat Fats and Vegetable cium disodium EDTA, 0.0075 percent; Oils’’ or ‘‘Shortening Prepared with stearyl citrate, 0.15 percent; isopropyl Vegetable Oils and Meat Fats’’ depend- citrate mixture, 0.02 percent. ing on the predominance of the fat and (6) Antioxidants identified in oils used, or the product may be la- § 318.7(c)(4) of this chapter, within these beled ‘‘Shortening’’ when accompanied maximum amounts in percent by by an ingredient statement with ingre- weight of the finished food: propyl, dients listed in descending order of pre- octyl and dodecyl gallates, BHT dominance. (butylated hydroxytoluene), BHA (butylated hydroxyanisole), ascorbyl § 319.702 Lard, leaf lard. palmitate, ascorbyl stearate, all indi- (a) Lard is the fat rendered from vidually or in combination, 0.02 per- clean and sound edible tissues from cent. Instead of these antioxidants, swine. The tissues may be fresh, frozen, TBHQ (tertiary butylhydroquinone), cooked, or prepared by other processes alone or in combination only with BHT approved by the Administrator in spe- and/or BHA, with a maximum 0.02 per- cific cases, upon his determination cent by weight of the fat and oil con- that the use of such processes will not tent. result in the adulteration or misbrand- (7) Coloring agents identified in ing of the lard. The tissues shall be rea- § 318.7(c)(4) of this chapter, in amounts sonably free from blood, and shall not sufficient for purpose.3 For the purpose of the Federal Food, Drug, and Cosmetic Act, 3 Colored margarine or oleomargarine is as amended (21 U.S.C. 347), as reflected in also subject to the provisions of section 407 § 317.8(h)(24) of this subchapter.

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include stomachs, livers, spleens, kid- § 319.721 Fluid extract of meat. neys, and brains, or settlings and Fluid extract of meat (e.g., ‘‘Fluid skimmings. ‘‘Leaf Lard’’ is lard pre- Extract of Beef’’) shall contain not pared from fresh leaf (abdominal) fat. more than 50 percent of moisture. (b) Lard (when properly labeled) may be hardened by the use of lard stearin or hydrogenated lard or both and may Subpart R—Meat Salads and Meat contain refined lard and deodorized Spreads lard, but the labels of such lard shall state such facts, as applicable. § 319.760 Deviled ham, deviled tongue, and similar products. (c) Products labeled ‘‘Lard’’ or ‘‘Leaf Lard’’ must have the following identity (a) ‘‘Deviled Ham’’ is a semiplastic and quality characteristics to insure cured meat food product made from good color, odor, and taste of finished finely comminuted ham and containing product: condiments. Mechanically Separated (1) Color ...... White when solid, Maximum 3.0 (Species) may be used in accordance red units in a 51¤4 inch cell on with § 319.6. Deviled ham may contain the Lovibond scale. added ham fat: Provided, That the total (2) Odor and taste ...... Characteristic and free from for- fat content shall not exceed 35 percent eign odors and flavors. (3) Free fatty acid ...... Maximum 0.5 percent (as oleic) of the finished product. The moisture or 1.0 acid value, as milligrams content of deviled ham shall not exceed KOH per gram of sample. that of the fresh unprocessed meat. (4) Peroxide value ...... Maximum 5.0 (as milliequivalents of peroxide per kilogram fat). (b) The moisture content of ‘‘Deviled (5) Moisture and volatile Maximum 0.2 percent. Tongue’’ and similar products shall not matter. exceed that of the fresh, unprocessed (6) Insoluble impurities .... By appearance of liquid, fat or meat. maximum 0.05 percent. (d) Product found upon inspection [35 FR 15597, Oct. 3, 1970, as amended at 43 FR not to have the characteristics speci- 26425, June 20, 1978; 47 FR 28257, June 29, 1982] fied in paragraph (c) of this section but § 319.761 Potted meat food product found to be otherwise sound and in and deviled meat food product. compliance with paragraph (a) of this section may be further processed for ‘‘Potted Meat Food Product’’ and the purpose of achieving such charac- ‘‘Deviled Meat Food Product’’ shall not teristics. contain cereal, vegetable flour, nonfat dry milk, or similar substances. The [43 FR 25420, June 13, 1978] amount of water added to potted meat food product and deviled meat food § 319.703 Rendered animal fat or mix- product shall be limited to that nec- ture thereof. essary to replace moisture lost during ‘‘Rendered Animal Fat,’’ or any mix- processing. ture of fats containing edible rendered animal fat, shall contain no added § 319.762 Ham spread, tongue spread, water, except that ‘‘Puff Pastry Short- and similar products. ening’’ may contain not more than 10 ‘‘Ham Spread,’’ ‘‘Tongue Spread,’’ percent of water. and similar products shall contain not [35 FR 15597, Oct. 3, 1970, as amended at 43 FR less than 50 percent of the meat ingre- 25420, June 13, 1978] dient named, computed on the weight of the fresh meat. Other meat and fat Subpart Q—Meat Soups, Soup may be used to give the desired spread- ing consistency provided it does not de- Mixes, Broths, Stocks, Extracts tract from the character of the spreads § 319.720 Meat extract. named. Mechanically Separated (Spe- cies) may be used in accordance with Meat extract (e.g., ‘‘Beef Extract’’) § 319.6. shall contain not more than 25 percent of moisture. [35 FR 15597, Oct. 3, 1970, as amended at 43 FR 26425, June 20, 1978; 47 FR 28257, June 29, 1982]

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Subpart S—Meat Baby Foods freezing, packaging, or labeling any [Reserved] carcasses, or parts or products of carcasses, of any such animals, for use as human food or animal food; Subpart T—Dietetic Meat Foods (2) Any person that engages in the [Reserved] business of buying or selling (as a meat broker, wholesaler, or otherwise), or Subpart U—Miscellaneous transporting in commerce, or storing in or for commerce, or importing, any § 319.880 Breaded products. carcasses, or parts or products of car- The amount of batter and breading casses, of any such animals; used as a coating for breaded product (3) Any person that engages in busi- shall not exceed 30 percent of the ness, in or for commerce, as a renderer, weight of the finished breaded product. or engages in the business of buying, selling, or transporting in commerce, § 319.881 Liver meat food products. or importing, any dead, dying, dis- Meat food products characterized and abled, or diseased cattle, sheep, swine, labeled as liver products such as liver goats, horses, mules, or other equines, loaf, liver cheese, liver spread, liver or parts of the carcasses of any such mush, liver paste, and liver pudding animals that died otherwise than by shall contain not less than 30 percent slaughter. of pork, beef, sheep, or goat livers com- (b) The required records are: puted on the fresh weight of the livers. (1) Records, such as bills of sale, invoices, bills of lading, and receiving [36 FR 12004, June 24, 1971] and shipping papers, giving the following information with respect to each PART 320—RECORDS, transaction in which any livestock or REGISTRATION, AND REPORTS carcass, part thereof, meat or meat food product is purchased, sold, Sec. shipped, received, transported, or oth- 320.1 Records required to be kept. erwise handled by said person in con- 320.2 Place of maintenance of records. nection with any business subject to 320.3 Record retention period. the Act: 320.4 Access to and inspection of records, fa- (i) The name or description of the cilities and inventory; copying and sampling. livestock or article; 320.5 Registration. (ii) The net weight of the livestock or 320.6 Information and reports required from article; official establishment operators. (iii) The number of outside contain- 320.7 Reports by consignees of allegedly ers (if any); adulterated or misbranded products; sale (iv) The name and address of the or transportation as violations. buyer of livestock or article sold by AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, such person, and the name and address 2.53. of the seller of livestock or articles SOURCE: 35 FR 15603, Oct. 3, 1970, unless purchased by such person; otherwise noted. (v) The name and address of the consignee or receiver (if other than the § 320.1 Records required to be kept. buyer); (a) Every person (including every (vi) The method of shipment; firm or corporation) within any of the (vii) The date of shipment; and classes specified in paragraph (a) (1), (viii) The name and address of the (2), or (3) of this section is required by carrier. the Act to keep records which will (ix) In the case of a person belonging fully and correctly disclose all trans- to the class specified in paragraph actions involved in his or its business (a)(1), and engaged, for commerce, in subject to the Act: the business of slaughtering any swine (1) Any person that engages, for com- for use as human or animal food, the merce, in the business of slaughtering name and address (including the city any cattle, sheep, swine, goats, horses, and state, or the township, county, and mules, or other equines, or preparing, state) of each person from whom the

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person belonging to the class so speci- § 320.2 Place of maintenance of fied purchased or otherwise obtained records. each swine, and the telephone number, Every person engaged in any business if available, of the person from whom described in § 320.1 and required by this the swine were purchased or otherwise part to keep records shall maintain obtained, and all serial numbers and such records at the place where such other approved means of identification business is conducted except that if appearing on all test swine selected at such person conducts such business at antemortem inspection by FSIS rep- multiple locations, he may maintain resentatives for residue testing. such records at his headquarters’ of- (2) Shipper’s certificates and permits fice. When not in actual use, all such required to be kept by shippers and records shall be kept in a safe place at carriers of articles under part 325 of the prescribed location in accordance this subchapter. with good commercial practices. (3) A record of seal numbers required § 320.3 Record retention period. to be kept by consignees of inedible products shipped under unofficial seals (a) Every record required to be main- under § 325.11(b) or (e) of this sub- tained under this part shall be retained chapter, and a record of new consignees for a period of 2 years after December of inedible products diverted under 31 of the year in which the transaction § 325.11(e) of this subchapter. to which the record relates has occurred and for such further period as (4) Records of processing procedures the Administrator may require for pur- for cooked beef and roast beef as re- poses of any investigation or litigation quired in § 318.17(d). under the Act, by written notice to the (5) Guaranties provided by suppliers person required to keep such records of packaging materials under § 317.20. under this part. (6) Records of canning as required by (b) Records of canning as required in subpart G of this subchapter A, 9 CFR subpart G of this subchapter A, 9 CFR chapter III. chapter III, shall be retained as re- (7) Sample results and calculation required in § 318.307(e); except that sults as required by processing proce- records required by § 318.302 (b) and (c) dures to destroy trichinae in shall be retained as required by those § 318.10(c)(3)(iv) (Methods 5 and 6). sections. (8) Records of nutrition labeling as [35 FR 15603, Oct. 3, 1970, as amended at 51 FR required by subpart B, part 317, of this 45633, Dec. 19, 1986] subchapter. (9) Records as required in § 318.23(b) § 320.4 Access to and inspection of rec- and (c). ords, facilities and inventory; copy- (10) Records of calcium content in ing and sampling. meat derived from advanced meat/bone Every person (including every firm or separation machinery and meat recov- corporation) within any of the classes ery systems as required by § 318.24 of specified in § 320.1 shall upon the pres- this subchapter. entation of official credentials by any (11) Records of all labeling, along duly authorized representative of the with the product formulation and proc- Secretary, during ordinary business essing procedures, as prescribed in hours, permit such representative to § 317.4 and § 317.5. enter his or its place of business and examine the records required to be (Approved by the Office of Management and kept by § 320.1 and the facilities and in- Budget under control number 0583–0015) ventory pertaining to the business of [35 FR 15603, Oct. 3, 1970, as amended at 36 FR such person subject to the Act, and to 12004, June 24, 1971; 37 FR 1229, Jan. 27, 1972; copy all such records and to take rea- 43 FR 30793, July 18, 1978; 47 FR 746, Jan. 7, sonable samples of the inventory upon 1982; 47 FR 17274, Apr. 22, 1982; 49 FR 2235, payment of the fair market value Jan. 19, 1984; 51 FR 45633, Dec. 19, 1986; 53 FR 40387, Oct. 14, 1988; 57 FR 27877, June 22, 1992; therefor. Any necessary facilities 58 FR 675, Jan. 6, 1993; 58 FR 41152, Aug. 2, (other than reproduction equipment) 1993; 59 FR 6897, Feb. 14, 1994; 59 FR 62562, for such examination and copying of Dec. 6, 1994; 60 FR 67456, Dec. 29, 1995] records and for such examination and

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sampling of inventory shall be afforded § 320.6 Information and reports re- to such authorized representative of quired from official establishment the Secretary. operators. (a) The operator of each official es- § 320.5 Registration. tablishment shall furnish to Program (a) Except as provided in paragraph employees accurate information as to (c) of this section, every person that all matters needed by them for making engages in business in or for commerce, their daily reports of the amount of as a meat broker, renderer, or animal products prepared or handled in the de- food manufacturer, or engages in busi- partments of the establishment to ness in commerce as a wholesaler of which they are assigned and such re- any carcasses, or parts or products of ports concerning sanitation, manda- the carcasses, or any livestock, wheth- tory microbiological testing, and other er intended for human food or other aspects of the operations of the estab- purposes, or engages in business as a lishment and the conduct of inspection, public warehouseman storing any such as may be required by the Adminis- articles in or for commerce, or engages trator in special cases. in the business of buying, selling, or (b) The operator of each official es- transporting in commerce, or import- tablishment shall report quarterly the ing, any dead, dying, disabled, or dis- number of pounds of meat and meat eased livestock, or parts of the car- food product produced at that estab- casses of any such livestock that died lishment. The report shall be made on otherwise than by slaughter, shall reg- a form furnished by the Administrator ister with the Administrator, giving and shall be submitted to an inspector such information as is required, includ- at the establishment. Each report shall ing his name, and the address of each cover a calendar quarter and shall be place of business at which, and all filed within 15 days after the end of trade names under which he conducts each quarter. (c) The operator of each official es- such business, by filing with the Ad- tablishment shall also make such other ministrator, Food Safety and Inspec- reports as the Administrator may from tion Service, U.S. Department of Agri- time to time require under the Act. culture, Washington, DC 20250, a form containing such information within 90 [35 FR 15603, Oct. 3, 1970, as amended at 45 FR days after the effective date hereof or 76968, Nov. 21, 1980; 61 FR 38866, July 25, 1996] after such later date as he begins to engage in such business if not engaged § 320.7 Reports by consignees of alleg- therein upon said effective date. All in- edly adulterated or misbranded products; sale or transportation as formation submitted shall be current violations. and correct. The registration form shall be obtained from the Compliance Whenever the consignee of any prod- Programs, Regulatory Programs, Food uct which bears an official inspection Safety and Inspection Service, U.S. De- legend refuses to accept delivery of partment of Agriculture, Washington, such product on the grounds that it is DC 20250. adulterated or misbranded, the consignee shall notify the Inspector in (b) Whenever any change is made in Charge, Meat and Poultry Inspection the name of, or address of any place of Program, Food Safety and Inspection business at which, or any trade name Service, U.S. Department of Agri- under which a registrant conducts his culture, of the kind, quantity, source, business, he shall report such change in and present location of the product and writing to the Administrator within 15 the respects in which it is alleged to be days after making the change. adulterated or misbranded, and it will (c) The registration requirements be a violation of the Act for any person prescribed in this section shall not to sell or transport, or offer for sale or apply to persons conducting any of the transportation, or receive for transpor- businesses specified in this section only tation, in commerce, any such product at an official establishment. which is capable of use as human food [35 FR 15603, Oct. 3, 1970, as amended at 57 FR and is adulterated or misbranded at the 53982, Nov. 16, 1992] time of such sale, transportation, offer,

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or receipt: Provided, however, That any for human food), when he determines such allegedly adulterated or mis- that such cooperation would effectuate branded product may be transported to the purposes of the Act. the official establishment from which (c) Such cooperation may include ad- it had been transported, in accordance visory assistance, technical and labora- with § 325.10 of this subchapter. tory assistance and training, and financial aid. The Federal contribution to PART 321—COOPERATION WITH any State (or Territory) may not ex- STATES AND TERRITORIES ceed 50 percent of the estimated total cost of the cooperative State (or Terri- torial) program. A cooperative pro- Sec. 321.1 Assistance to State and Territorial gram under this section is called a programs. State-Federal program. 321.2 Cooperation of States in Federal pro- [35 FR 15604, Oct. 3, 1970] grams.

AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, § 321.2 Cooperation of States in Fed- 2.55. eral programs. Under the ‘‘Talmadge-Aiken Act’’ of § 321.1 Assistance to State and Terri- September 28, 1962 (7 U.S.C. 450), the torial programs. Administrator is authorized to utilize (a) The Administrator is authorized employees and facilities of any State under paragraph (a) of section 301 of in carrying out Federal functions the Act, when he determines it would under the Federal Meat Inspection Act. effectuate the purposes of the Act, to A cooperative program for this purpose cooperate with any State (including is called a Federal-State program. Puerto Rico) or any organized Terri- tory in developing and administering [35 FR 15604, Oct. 3, 1970] the meat inspection program of such 1 jurisdiction with a view to assuring PART 322—EXPORTS that it imposes and enforces requirements at least equal to those under Ti- Sec. tles I and IV of the Act, with respect to 322.1 Manner of affixing stamps and marking products for export. establishments at which products are 322.2 Export certificates; instructions con- prepared for use as human food solely cerning issuance. for distribution within such jurisdic- 322.3 Transferring products for export. tion, and with respect to the products 322.4 Clearance of vessels and transpor- of such establishments. Such coopera- tation without certificate prohibited; ex- tion is authorized if the jurisdiction ceptions. has enacted a law imposing mandatory 322.5 Uninspected tallow, stearin, oleo oil, etc., not to be exported unless certified ante-mortem and post-mortem inspec- as prescribed. tion, reinspection, and sanitation requirements at least equal to the Fed- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, eral requirements with respect to all or 2.55. certain classes of persons engaged in SOURCE: 35 FR 15604, Oct. 3, 1970, unless slaughtering livestock or otherwise otherwise noted. preparing products solely for distribu- § 322.1 Manner of affixing stamps and tion within such jurisdiction. marking products for export. (b) The Administrator is also author- (a) The outside container (including ized under paragraph (a) of section 301 cloth wrappings) of any inspected and of the Act to cooperate with any State passed product for export, except ship (including Puerto Rico) or any orga- stores, small quantities exclusively for nized Territory in developing and administering programs under the laws of such jurisdiction containing authori- 1 Attention is directed to the requirements ties at least equal to those in Title II of part 325 of this subchapter, governing transportation, and to the requirements of of the Act (relating to records; reg- § 318.8 of this subchapter that products pre- istration of specified classes of opera- pared under that section for export be de- tors; dead, dying, disabled, or diseased stroyed for food purposes before being sold or livestock; and products not intended offered for sale for domestic use.

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the personal use of the consignee and certificate which supersedes it, as fol- not for sale or distribution, and ship- lows: ‘‘Superseded by No. ——’’. ments by and for the U.S. Armed (d) The original of the certificate Forces, shall be marked with an offi- shall be delivered to the shipper and cial export stamp, as shown in § 312.8 of may be furnished by him to the con- this subchapter, bearing the number of signee for purposes of effecting the the export certificate. entry of product into the foreign coun- (b) Each tank car of inspected and try of destination. passed lard or similar edible product, (e) The duplicate of the certificate and each door of each railroad car or shall be delivered to the shipper and other closed means of conveyance, con- shall be delivered by the shipper to the taining inspected and passed loose agent of the railroad or other carrier product shipped directly to a foreign which transports the consignment from country, shall be marked with an offi- the United States otherwise than by cial export stamp, as shown in § 312.8 of water, or to the chief officer of the ves- this subchapter, bearing the number of sel on which the export shipment is the export certificate. made, or to the vessel’s agent and shall [42 FR 11825, Mar. 1, 1977, as amended at 50 be used only by such carrier and only FR 25204, June 18, 1985] for the purpose of effecting the transportation of the consignment certified. § 322.2 Export certificates; instructions The chief officer of the vessel or the concerning issuance. vessel’s agent, shipper or shipper’s (a) Upon application of the exporter, agent shall file such duplicate with the the inspector in charge is authorized to Customs officer within four (4) business issue official export certificates for days of the clearance of the vessel at shipments of inspected and passed the time of filing the complete mani- product to any foreign country. Certifi- fest. In the interim period, the vessel cates should be issued at the time the will be cleared by Customs on the basis products leave the official establish- of a statement, under the shipper’s or ment; if not issued at that time they agent’s letterhead, containing the may be issued later only after identi- number of boxes, the number of fication and reinspection of the prod- pounds, the product name and the ucts. USDA export certificate number that (b) Official export certificates shall covers the shipment of the product. No be issued with serial numbers and in clearance shall be given to a vessel car- triplicate form. Quadruplicate certifi- rying meat products unless either the cates may be issued for any expor- duplicate of the certificate or the pre- tation on request of the exporter. Each scribed statement referencing the cer- certificate shall show the names of the tificate has been presented to Customs. exporter and the consignee, the des- (f) The triplicate of the certificate tination, the number and types of shall be retained in the circuit file. packages, the shipping marks, the (g) Under no circumstances shall the kinds of products, and the weight of original or the triplicate of such cer- the products in accordance with § 317.2 tificate be used for the purpose pre- of this subchapter. scribed by paragraph (e) of this section (c) Only one certificate shall be is- for the duplicate. sued for each consignment, except that for sufficient reasons new certificates (h) Upon request, official export cer- in lieu of the original certificates may tificates may be issued by inspectors be issued. A certificate issued in lieu of for export consignments of product of another shall show in the left hand official establishments not under their margin the notation ‘‘Issued in lieu of supervision, provided the consignments * * *’’, and the number of the certifi- are first identified as having been cate which is superseded. The certifi- ‘‘U.S. inspected and passed’’ and are cate that is superseded when another is found to be neither adulterated nor issued in lieu thereof, shall if available, misbranded, and marked as required by be surrendered to the inspector in § 322.1. charge and marked by him to show in [35 FR 15604, Oct. 3, 1970, as amended at 42 FR the left hand margin the number of the 11826, Mar. 1, 1977; 51 FR 31938, Sept. 8, 1986]

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§ 322.3 Transferring products for ex- without official inspection legend or cer- port. tificate when required; exceptions; and vehicle sanitation requirements. When inspected and passed products 325.2 Parcel post and ferries deemed car- for export are transferred from tank riers. cars to other containers on vessels, 325.3 Product transported within the United such transfer shall be done in accord- States as part of export movement. ance with the provisions of part 350 of 325.4 [Reserved] subchapter B of this chapter. 325.5 Unmarked inspected product transported under official seal between official § 322.4 Clearance of vessels and trans- establishments for further processing; portation without certificate pro- certificate. hibited; exceptions. 325.6 Shipment of paunches between official No clearance shall be given to any establishments under official seal; cer- vessel having on board any product tificate. destined to any foreign country, and no 325.7 Shipment of products requiring special person operating any vessel, and no supervision between official establishments under official seal; certificate. railroad or other carrier, shall receive 325.8 Transportation and other transactions for transportation or transport from concerning certain undenatured lungs or the United States to any foreign coun- lung lobes from official establishments try, any products, unless and until an or in commerce; provisions and restric- official export certificate covering the tions. same has been issued and delivered as 325.9 [Reserved] provided in this part; except in the case 325.10 Handling of products which may have of inspected and passed ship stores and become adulterated or misbranded; au- not more than 50 pounds of inspected thorization and other requirements. and passed product for the exclusive 325.11 Inedible articles: denaturing and personal use of the consignee and not other means of identification; exceptions. for sale or distribution, and except for 325.12 [Reserved] exempted product eligible for expor- 325.13 Denaturing procedures. tation under the provisions of the Act 325.14 Certificates, retention by carrier. and the regulations in this subchapter 325.15 Evidence of proper certification re- and inedible product that is not capa- quired on waybills; transfer bills, etc., ble of use as human food and is eligible for shipment by connecting carrier; for exportation under other provisions forms of statement. of said regulations. 325.16 Official seals; forms, use, and break- [38 FR 18868, July 16, 1973] ing. 325.17 Loading or unloading products in § 322.5 Uninspected tallow, stearin, sealed railroad cars, trucks, etc., en oleo oil, etc., not to be exported un- route prohibited; exception. less certified as prescribed. 325.18 Diverting of shipments, breaking of No tallow, stearin, oleo oil, or the seals, and reloading by carrier in emer- rendered fat derived from the carcasses gency; reporting to Regional Director. 325.19 Provisions inapplicable to specimens of livestock, that has not been infor laboratory examination, etc., or to spected and passed, and so marked in naturally inedible articles. compliance with the regulations in this 325.20 Transportation and other trans- subchapter shall be exported, unless actions concerning dead, dying, disabled, the product has been denatured as re- or diseased livestock, and parts of car- quired by § 314.5 or § 325.13 of this sub- casses of livestock that died otherwise chapter or identified and marked as than by slaughter. prescribed by § 325.11 of this sub- 325.21 Means of conveyance in which dead, chapter. dying, disabled, or diseased livestock and parts of carcasses thereof shall be trans- [35 FR 15604, Oct. 3, 1970, as amended at 47 FR ported. 17274, Apr. 22, 1982] AUTHORITY: 7 U.S.C. 450, 1901–1906; 21 U.S.C. PART 325—TRANSPORTATION 601–695; 7 CFR 2.17, 2.55. SOURCE: 35 FR 15605, Oct. 3, 1970, unless Sec. otherwise noted. 325.1 Transactions in commerce prohibited

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§ 325.1 Transactions in commerce pro- placed therein will not become adulter- hibited without official inspection ated. Any cleaning compound, lye, soda legend or certificate when required; solution, or other chemical used in exceptions; and vehicle sanitation cleaning the means of conveyance must requirements. be thoroughly removed from the means (a) No person shall sell, transport, of conveyance prior to its use. Such offer for sale or transportation, or re- means of conveyance onto which prod- ceive for transportation, in commerce, uct is loaded, being loaded, or intended any product which is capable of use as to be loaded, shall be subject to inspec- human food unless the product and its tion by an inspector at any official es- container, if any, bear the official in- tablishment. The decision whether or spection legend as required under parts not to inspect a means of conveyance 316 and 317 of this subchapter or such in a specific case, and the type and ex- product is exempted from the require- tent of such inspection shall be at the ment of inspection under part 303 of Program’s discretion and shall be ade- this subchapter. quate to determine if product in such (b)(1) No carrier shall transport or re- conveyance is, or when moved could be- ceive for transportation in commerce come, adulterated. Circumstances of (including transportation in the course transport that can be reasonably an- of importation) and no person shall ticipated shall be considered in making offer for transportation any carcass, said determination. These include, but part thereof, meat or meat food prod- are not limited to, weather conditions, uct until a certificate, if required for duration and distance of trip, nature of such transportation by this part, is product covering, and effect of restow- made and furnished to the carrier in age at stops en route. Any means of one of the forms prescribed in this conveyance found upon such inspection part. to be in such condition that product (2) Product imported into the United placed therein could become adulter- States may be transported and offerred ated shall not be used until such condi- or received for transportation if such tion which could cause adulteration is product is conveyed in railroad cars, corrected. Product placed in any means trucks or other means of conveyance, of conveyance that is found by the in- prior to inspection, to an authorized spector to be in such condition that the place of inspection, as provided in product may have become adulterated § 327.6 of this part. shall be removed from the means of (c) No person, engaged in the busi- conveyance and handled in accordance ness of buying, selling, freezing, stor- with § 318.2(d) of this subchapter. ing, or transporting, in or for commerce, meat or meat food products ca- [35 FR 15605, Oct. 3, 1970, as amended at 41 FR pable of use as human food, or import- 23700, June 11, 1976; 47 FR 17274, Apr. 22, 1982; ing such articles, shall transport, offer 56 FR 65180, Dec. 16, 1991] for transportation, or receive for transportation in commerce or in any State § 325.2 Parcel post and ferries deemed carriers. designated under § 331.2 of this subchapter, any such meat or meat food (a) For the purposes of this sub- product which is capable of use as chapter, the United States parcel post human food and is not wrapped, shall be deemed a carrier, and the pro- packaged, or otherwise enclosed to pre- visions of this subchapter relating to vent adulteration by airborne contami- transportation by carrier shall apply, nants, unless the railroad car, truck, or so far as they may be applicable, to other means of conveyance in which transportation by parcel post. the product is contained or transported (b) For the purposes of this sub- is completely enclosed with tight fit- chapter, the operator of every ferry ting doors or other covers for all open- shall be deemed a carrier, and the pro- ings. In all cases, the means of convey- visions of this subchapter relating to ance shall be reasonably free of foreign transportation by carrier shall apply to matter (such as dust, dirt, rust, or transportation by ferry of any products other articles or residues), and free of loaded on a truck or other vehicle, or chemical residues, so that product otherwise moved by such ferry.

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§ 325.3 Product transported within the Meat and Poultry Inspection Programs of United States as part of export said Department, and the means of convey- movement. ance has been sealed by him with official U.S. Government seals Nos. —— and ——. When any shipment of any product is offered to any carrier for transportation within the United States as a Kind of product Amount and weight part of an export movement, the same ———————————————————————— certificate shall be required as if the ———————————————————————— shipment were destined to a point ———————————————————————— within the United States. (Signature of shipper) § 325.4 [Reserved] (Address of shipper) § 325.5 Unmarked inspected product transported under official seal be- When paunches are offered for trans- tween official establishments for portation under this paragraph, the further processing; certificate. initial carrier shall require, and the (a) Any product which has been in- shipper shall make in duplicate and de- spected and passed may be transported liver to the carrier, one copy of a cer- from one official establishment to an- tificate in duplicate in the form set out other for further processing without in § 325.5(b), appropriately modified. each article being marked with the of- Certificates in this form or copies ficial inspection legend, if it is so thereof need not be forwarded to any transported in a railroad car, official or office of the Department, motortruck, or other means of convey- but the original of the certificate shall ance which is sealed by a Program em- be retained by the carrier and a copy ployee with an official seal of the De- shall be retained by the shipper in ac- partment prescribed in § 312.5(a) of this cordance with part 320 of this sub- subchapter. Unless 25 percent or more chapter. If the shipper is also the car- of the contents of each car or other rier, he shall nevertheless execute and means of conveyance consists of prod- retain the certificate in accordance uct not marked with the inspection with part 320 of this subchapter. legend, transportation will not be per- (c) The signature of the shipper or his mitted under this paragraph. agent shall be written in full. This cer- (b) When articles are offered for tificate may be stamped upon or incor- transportation under paragraph (a) of porated in any form ordinarily used in this section, the initial carrier shall re- the transportation of product. Certifi- quire, and the shipper shall make in cates in this form or copies thereof duplicate and deliver to the carrier, need not be forwarded to any official or one copy of a certificate in the follow- office of the Department. The original ing form: 1 of the certificate required by this sec- Date lllll, 19l tion shall be retained by the carrier Name of carrier ——————————————— Establishment number of consignor ———— and a copy shall be retained by the Point of shipment —————————————— shipper in accordance with part 320 of Establishment number of consignee ———— this subchapter. If the shipper is also Destination ————————————————— the carrier, he shall nevertheless exe- Car number and initials ——————————— cute and retain the certificate in ac- License number of other means of convey- cordance with part 320 of this sub- ance ———————————————————— chapter. I hereby certify that the following described product has been U.S. inspected and § 325.6 Shipment of paunches between passed by the U.S. Department of Agri- official establishments under offi- culture; and that it is not marked ‘‘U.S. in- cial seal; certificate. spected and passed,’’ but has been placed in the means of conveyance specified above Cattle and sheep paunches which under the supervision of an employee of the have been made clean and from which the mucous membrane has not been re- 1 For convenience in filing, it is requested moved may be transported from one of- that these certificates be made on paper 51⁄2 ficial establishment to another official x 8 inches in size. establishment for further processing,

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only under an official seal of the De- other product in the vehicle is un- partment as prescribed in § 312.5(a) of marked. For each consignment there this subchapter. shall be promptly issued and forwarded by the inspector to the inspector in § 325.7 Shipment of products requiring charge at destination, a report on the special supervision between official form entitled ‘‘Notice of Unmarked establishments under official seal; Meats Shipped in Sealed Cars,’’ appro- certificate. priately modified to show the char- (a) Products passed for cooking, pork acter of the containers, and that the that has been refrigerated to destroy contents are restricted. A duplicate trichinae, and beef that is to be refrig- copy shall be retained in the program erated to destroy cysticerci, may be files. shipped loose from one official estab- (c) When products are offered for lishment to any other official estab- transportation under this section, the lishment, for further handling in ac- initial carrier shall require and the cordance with part 318 of this sub- shipper shall make in duplicate and de- chapter, in railroad cars, trucks, or liver to the carrier one copy of a cer- other means of conveyance sealed with tificate in the form set out in § 325.5(b). the official seal of the Department as Certificates in this form or copies prescribed in § 325.16: Provided, That in thereof need not be forwarded to any the case of railroad cars, the receiving official or office of the Department, establishment has railroad facilities but the original of the certificate shall for unloading the products directly be retained by the carrier and a copy into the establishment. shall be retained by the shipper in ac- (b) When such restricted product is cordance with part 320 of this sub- shipped from one official establishment chapter. If the shipper is also the car- to another official establishment in the rier, he shall nevertheless execute and same railroad car or other means of retain the certificate in accordance conveyance with other product, such with part 320 of this subchapter. restricted product shall be packed in [35 FR 15605, Oct. 3, 1970, as amended at 39 FR individual closed containers as herein- 20187, June 7, 1974] after provided. Containers shall be sealed by firmly applying a pressure § 325.8 Transportation and other sensitive tape around each container in transactions concerning certain two directions and stamping the inter- undenatured lungs or lung lobes section of the tape with the marking from official establishments or in device described in § 312.2(a) of this sub- commerce; provisions and restric- chapter for use on burlap, muslin, etc. tions. (21⁄2-inch rubber brand). Such tape must (a) Lungs or lung lobes, other than possess the adhesive property to actu- those condemned under § 310.16(b) of ally remove a portion of the container this subchapter, that are prepared at surface when the tape is removed. Al- any official establishment, may be ternatively, an inelastic, nonmetallic sold, transported, offered for sale or strap which will retain a legible im- transportation, or received for trans- print of the marking device (21⁄2-inch portation from the establishment, in rubber brand) may be used. The im- commerce or otherwise, without dena- print of the marking device shall be turing as prescribed in § 314.1 or § 314.3 placed partially on the strap and par- of this subchapter: Provided: tially on the container. Such restricted (1) The lungs or lung lobes are sold, product shall be marked ‘‘U.S. passed transported, or offered for sale or for cooking’’ or ‘‘pork product —— transportation to, or received for °F.——days refrigeration’’ or ‘‘beef transportation by: An animal food passed for refrigeration,’’ as the case manufacturer for use in manufacturing may be. In addition, a ‘‘U.S. retained’’ animal food; a zoo, mink farm, or other tag shall be securely affixed to each establishment for use as animal food container of product passed for cooking without further processing; a ware- and of beef passed for refrigeration. house in the United States for storage The means of conveyance shall not be and subsequent movement to such a sealed unless at least 25 percent of the manufacturer or establishment in the

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United States, or from one warehouse (d) All such lungs or lung lobes, if in- to another for the account of and sub- tended for animal food, are subject to sequent movement to such a manufac- the Federal Food, Drug, and Cosmetic turer or establishment, or for export, Act. for nonhuman food purposes. [43 FR 43445, Sept. 26, 1978] (2) The boxes or other containers used for shipping the undenatured § 325.9 [Reserved] lungs or lung lobes are closed with nylon filament tape, metallic on non- § 325.10 Handling of products which metallic straps, round wire, or other may have become adulterated or similar materials that securely effect misbranded; authorization and other requirements. closure of such containers, and the containers are permanently identified in (a) When it is claimed that any in- at least 2-inch (5 cm) high lettering spected and passed product, marked with the statement ‘‘(Species) Lungs— with an inspection legend, has become Not Intended for Human Food.’’ In lieu adulterated or misbranded after it has of securely closing the immediate con- been transported from an official es- tainer with any of the above materials, tablishment, such product may be a 1-inch (2.5 cm) wide bright orange transported in commerce to an official band, imprinted around the length and establishment after oral permission is width of the container may be used. obtained from the area supervisor of the area in which that offical establish- (3) The name and place of business of ment is located. The transportation of the packer or distributor shall be the product may be to the official es- shown on the immediate container of tablishment from which it had been the product. In addition, the country of transported or to another official es- origin shall be shown on the immediate tablishment designated by the person container of imported lungs or lung desiring to handle the product. The lobes. transportation shall be authorized only (b) Lungs or lung lobes, other than for the purpose of officially determin- those condemned under a State law or ing if the product has become adulter- regulation at least equal to § 310.16(b) ated or misbranded and making the ap- of this subchapter, that are prepared at propriate disposition. The area super- any State inspected establishment may visor shall make a record of the au- be sold, transported, offered for sale, or thorization and such other information transportation or received for trans- which will effectively identify the ship- portation from that establishment, in ment and shall provide a copy of the commerce, without denaturing as pre- record to the inspector at the estab- scribed under section 201 of the Act, lishment receiving the product. The provided the State law or regulations shipper shall be furnished a copy of the permit such disposition and provided authorization record upon request. there is compliance with the provisions (b) Upon the arrival of the shipment of paragraph (a) of this section. at the official establishment, a careful (c) Foreign establishments shall be inspection shall be made of the product eligible to export lungs or lung lobes, by a Program inspector, and if it is other than those condemned for rea- found that the article is not adulter- sons set forth in § 310.16(b) of this sub- ated, the same may be received into chapter, to the United States from the establishment; but if the article is such foreign country under this sec- found to be adulterated, it shall at tion, only if such establishments are once be stamped ‘‘U.S. inspected and certified and approved for export of condemned’’ and disposed of in accord- products to the United States under ance with part 314 of this subchapter, part 327 of this subchapter, and such and if it is found to be misbranded, it product complies with the applicable shall be handled in accordance with regulations for preventing the intro- § 318.2(d) of this subchapter: Provided, duction into the United States of dis- That when a product is found to be af- eases (9 CFR 94), in addition to the re- fected with one of the correctable con- quirements of paragraph (a) of this sec- ditions specified in § 318.2(d) of this sub- tion. chapter, in respect to which rehandling

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is permitted, it may be transported solely by the consignee for manufac- from the official establishment to an- turing purposes of nonhuman food arti- other official establishment for such cles and may not be further sold or rehandling as is necessary to assure shipped without first receiving ap- that the product is not adulterated or proval of the Regional Director: And misbranded when finally released. The provided further, That such fat intended transportation of such a product from for export and stored at a terminal an official establishment shall be done point prior to export will be subject to in a manner prescribed in each specific review by Program employees to assure case by the Administrator. that it is exported as inedible. [35 FR 15605, Oct. 3, 1970, as amended at 47 FR (3) When transported in commerce, or 17274, Apr. 22, 1982] imported, such inedible rendered fat shall be marked conspicuously with the § 325.11 Inedible articles: denaturing words ‘‘technical animal fat not in- and other means of identification; tended for human food’’ on the ends of exceptions. the shipping containers, in letters not (a) Except as provided in § 325.8 and less than 2 inches high; in the case of § 325.10, no carcass, part of a carcass, shipping containers such as drums, rendered grease, tallow, or other fat de- tierces, barrels, and half barrels, and rived from the carcasses of livestock, not less than 4 inches high in the case or other meat food product, that has of tank cars and trucks. All shipping not been inspected and passed at an of- containers shall have both ends painted ficial establishment under the provi- with a durable paint, if necessary, to sions of this subchapter and is not ex- provide a contrasting background for empted from such inspection, and no the required marking. carcass, part of a carcass, fat or other (4) Such inedible rendered fat shall be meat food product that is adulterated transported only in sealed shipping or misbranded, shall be offered for containers bearing unofficial seals ap- transportation in commerce by any plied by the shipper, which shall in- person unless it is handled in accord- clude the identification number as- ance with paragraph (b), (c), (d), or (e) signed by said Director for the permit of this section or is denatured or other- holder. The number shall appear on the wise identified as prescribed in § 325.13, bill of lading or other transportation § 314.1, § 314.3, § 314.9, § 314.10, or § 314.11 documents for the shipment. The con- of this subchapter. signees in the United States must re- (b) Inedible rendered animal fats tain the seals in their records as pre- from official or other establishments in scribed in part 320 of this subchapter. the United States having the physical (5) Any diversion or effort to divert characteristics of a meat food product inedible rendered fat contrary to the fit for human food may be transported provisions of this paragraph (b) or in commerce without denaturing, if the other violation of the provisions of this following conditions are met: section may result in the revocation of (1) Such inedible rendered fat shall the permit for shipment of technical not be bought, sold, transported, or of- animal fat at the discretion of the Ad- fered for sale or offered for transpor- ministrator. tation in commerce, or imported, ex- (c) Inedible rendered animal fat de- cept by rendering companies, dealers, rived from condemned or other inedible brokers, or others who obtain a num- materials at official or other establish- bered permit for such activities from ments in the United States may be the Regional Director. transported in commerce if mixed with (2) Such inedible rendered animal fat low grade offal or other materials may be so distributed only if consigned which render the fat readily distin- to a domestic manufacturer of tech- guishable from an article of human nical articles other than for human food, and if the outside container bears food or to an export terminal for expor- the word ‘‘inedible.’’ tation or storage for exportation as an (d)(1) Except as provided in para- inedible article, and provided, in the graphs (d)(2), (3), and (4) of this section, case of such fat consigned to a domes- or in §§ 314.10 and 314.11 of this sub- tic manufacturer, the product is for use chapter, no animal food prepared, in

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whole or in part, from materials de- unit, whether stated on a single line or rived from the carcasses of livestock in more than one line, and the letters de- an official establishment or elsewhere, noting the article’s intended use for shall be bought, sold, transported, of- animal food are at least as high, wide, fered for sale or transportation, or re- and thick as the letters indicating the ceived for transportation, in com- presence of material derived from any merce, or imported, unless: livestock carcass. However, when the (i) It is properly identified as animal label bears on its principal display food; panel a vignette which pictures, in (ii) It is not represented as being a clearly recognizable form and size, one human food; and or more animals of the species for (iii) It has been denatured as pre- which the article’s name indicates the scribed in § 325.13(a)(2) so as to be read- article is intended, the letters used to ily distinguishable from an article of state the article’s intended use shall be human food. at least one-half as high, wide, and (2) Notwithstanding the provisions of thick as the letters used in the arti- paragraph (d)(1) of this section, an ani- cle’s name or other letters indicating mal food that consists of less than 5 percent of parts or products of the car- the presence of material derived from casses of livestock and that is not rep- any livestock carcass, but shall not be 1 resented by labeling or appearance or less than ⁄8 inches high. The letters otherwise as being a human food or as used to state the article’s intended use a product of the meat food industry may be separated from the article’s need not be denatured in accordance name by the vignette. with § 325.13(a)(2). (iii) Letters used to denote the in- (3) Notwithstanding the provisions of tended use of the article must contrast paragraph (d)(1) of this section, animal as markedly with their background as food packed in hermetically sealed, re- the letters indicating the presence in tort processed, conventional retail-size the article of livestock carcass-source containers, and retail-size packages of material contrast with their back- semi-moist animal food need not be de- ground. natured in accordance with § 325.13(a)(2) (4) The requirements of this part do if the name of the article clearly con- not apply to livestock or poultry feeds veys the article’s intended use for ani- manufactured from processed livestock mal food and appeared on the label in a byproducts (such as meat meal tank- conspicuous manner. age, meat and bone meal, blood meal, (i) Except as provided in paragraph and feed grade animal fat), or to proc- (ii) of paragraph (d)(3), the name of the essed dry animal food. article must be stated on the label as (e) Except for inedible rendered ani- ‘‘Animal Food,’’ ‘‘Pet Food,’’ or mal fats and lungs or lung lobes, ined- ‘‘(name of species) Food’’ (e.g., ‘‘Dog ible products (including condemned Food’’ or ‘‘Cat Food’’). To be consid- products only if condemned for causes ered conspicuous, the name of the arti- specified in § 314.11 of this subchapter) cle, wherever it appears on the label, must be in letters at least twice as which were prepared at any official es- high, wide, and thick as the letters in- tablishment, or at any State inspected dicating the presence in the article of establishment in any State not listed any ingredients derived from the car- in § 331.2 of this subchapter, and which casses of livestock. have the physical characteristics of a (ii) Notwithstanding the provisons of product fit for human food, may be paragraph (i) of this paragraph (d)(3), transported from an official establish- the article’s name may be stated on ment or in commerce, without denatur- the label to show that it is or contains ing as required by this subchapter, if livestock-source material and that the the following conditions are met: article is for animals; e.g., ‘‘Horsemeat (1) The shipper must have obtained a for Pets’’ or ‘‘Beef Stew for Dogs’’: Pro- numbered permit for such activity vided, That the entire name of the arti- from the appropriate Regional Direc- cle is stated, wherever it appears on tor, as identified in § 301.2 of this sub- the label, as an individual, contiguous chapter. Such permit may be obtained

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upon written application to the appro- or other violation of the provisions of priate Regional Director and his deter- this section may result in the revoca- mination that the proposed transpor- tion of the permit for shipment of ined- tation would be authorized under this ible products under this paragraph (e), paragraph (e). The application shall at the discretion of the Administrator. state the name and address of the applicant, a description of the type of his [47 FR 17274, Apr. 22, 1982, as amended at 49 FR 47478, Dec. 5, 1984] business operations, and the purpose of making such application. § 325.12 [Reserved] (2) Such inedible products may be transported under this paragraph (e) § 325.13 Denaturing procedures. only if consigned to a manufacturer in the United States of articles other (a) Carcasses, parts thereof, meat and than for human food and if the product meat food products (other than ren- is for use solely by the consignee for dered animal fats) that have been manufacturing articles not for human treated in accordance with the provi- food. Such products may not be trans- sions of this paragraph shall be consid- ported in commerce to any consignee ered denatured for the purposes of the other than the one to which they were regulations in this part, except as oth- originally shipped unless prior notice erwise provided in part 314 of this sub- of the diversion is given to the appro- chapter for articles condemned at offi- priate Regional Director and a record cial establishments. identifying the new consignee is main- (1) The following agents are pre- tained by the shipper as required by scribed for denaturing carcasses, parts § 320.1 of this subchapter. thereof, meat or meat food products (3) When transported from an official which are affected with any condition establishment or in commerce under that would result in their condemna- this paragraph (e), the outside con- tion and disposal under part 314 of this tainer of such inedible products shall subchapter if they were at an official be marked conspicuously with the establishment: Crude carbolic acid; words ‘‘Inedible—Not Intended for cresylic disinfectant; a formula con- Human Food’’ in letters not less than 2 sisting of 1 part FD&C green No. 3 inches high, in the case of containers, coloring, 40 parts water, 40 parts liquid such as cartons, drums, tierces, bar- detergent, and 40 parts oil of citronella, rels, and half barrels, and not less than or other proprietary substance ap- 4 inches high in the case of tank cars proved by the Administrator in specific and trucks used to transport such prod- cases. 3 ucts not in other containers. (2) Except as provided in paragraphs (4) Such inedible products shall be (a)(3), (4), and (5) of this section, the transported from an official establish- following agents are prescribed for de- ment or in commerce under this para- naturing other carcasses, parts thereof, graph (e) only in railroad cars, trucks, meat and meat food products, for or containers which bear unofficial which denaturing is required by this seals applied by the shipper, which part: FD&C green No. 3 coloring; FD&C shall include the identification number blue No. 1 coloring; FD&C blue No. 2 assigned to the permit holder and an coloring; finely powdered charcoal; or individual seal serial number assigned other proprietary substance approved by the shipper; and the product so by the Administrator in specific cases. 3 transported shall be accompanied by an (3) Tripe may be denatured by dip- invoice or bill of lading specifying the ping it in a 6 percent solution of tannic permit holder’s identification number. acid for 1 minute followed by immer- The consignee in the United States sion in a water bath, then immersing it must retain a record of the identification and serial numbers shown on the 3 seals in his records as prescribed in Information as to approval of any proprietary denaturing substance may be obtained part 320 of this subchapter. from the Technical Services, Meat and Poul- (5) Any diversion, or effort to divert, try Inspection, Food Safety and Inspection undenatured, inedible product contrary Service, U.S. Department of Agriculture, to the provisions of this paragraph (e) Washington, DC 20250.

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for 1 minute in a solution of 0.022 per- (b) Inedible rendered animal fats cent FD&C yellow No. 5 coloring; shall be denatured by thoroughly mix- (4) Meat may be denatured by dipping ing therein denaturing oil, No. 2 fuel it in a solution of 0.0625 percent tannic oil, brucine dissolved in a mixture of acid, followed by immersion in a water alcohol and pine oil or oil of rosemary, bath, then dipping it in a solution of finely powdered charcoal, or any pro- 0.0625 percent ferric acid; and prietary denaturing agent approved for (5) When meat, meat byproducts, or the purpose by the Administrator in meat food products are in ground form, specific cases. The charcoal shall be 4 percent by weight of coarsely ground used in no less quantity than 100 parts hard bone, which shall be in pieces no per million and shall be of such char- smaller than the opening size specified acter that it will remain suspended infor No. 5 mesh in the standards issued definitely in the liquid fat. Sufficient by the U.S. Bureau of Standards or 6 of the chosen identifying agents shall percent by weight of coarsely ground be used to give the rendered fat so dis- hard bone, which shall be in pieces no tinctive a color, odor, or taste that it smaller than the opening size specified cannot be confused with an article of for No. 8 mesh in said Standards, uni- human food. formly incorporated with the product [35 FR 15605, Oct. 3, 1970, as amended at 41 FR may be used in lieu of the agents pre- 22930, June 8, 1976; 44 FR 67626, Nov. 27, 1979] scribed in paragraph (a)(2) of this section. § 325.14 Certificates, retention by car- (6) Before the denaturing agents are rier. applied to articles in pieces more than All original certificates delivered to 4 inches in diameter, the pieces shall a carrier in accordance with this part be freely slashed or sectioned. (If the shall be filed separate and apart from articles are in pieces not more than 4 all its other papers and records or iden- inches in diameter, slashing or section- tified in such a manner as to be readily ing will not be necessary.) The applica- checked by Department employees. tion of any of the denaturing agents Every certificate required to be main- listed in paragraph (a)(1) or (2) of this tained under this part shall be retained section to the outer surface of molds or for a period of 2 years after December blocks of boneless meat, meat byprod- 31 of the year in which the transaction ucts, or meat food products shall not has occurred. be adequate. The denaturing agent must be mixed intimately with all of § 325.15 Evidence of proper certifi- the material to be denatured, and must cation required on waybills; trans- be applied in such quantity and manner fer bills, etc., for shipment by con- that it cannot easily and readily be re- necting carrier; forms of statement. moved by washing or soaking. A suffi- (a) All waybills, transfer bills, run- cient amount of the appropriate agent ning slips, conductor’s cards, or other shall be used to give the material a dis- papers accompanying a shipment, in tinctive color, odor, or taste so that the course of importation or otherwise such material cannot be confused with in commerce, of any product shall have an article of human food. embodied therein, stamped thereon, or (7) Carcasses (other than viscera), attached thereto a signed statement parts thereof, cuts of meat, and which shall be evidence to connecting unground pieces of meat darkened by carriers that the proper shipper’s cer- charcoal or other black dyes shall be tificate, as required by § 325.5, § 325.6, or deemed to be denatured pursuant to § 325.7, is on file with the initial carrier. this section only if they contain at No connecting carrier shall receive for least that degree of darkness depicted transportation or transport in the by diagram 1 of the Meat Denaturing 1 Guide (MP Form 91). Minnesota 55403. Diagrams 2 and 3 of the Meat Denaturing Guide are for comparison 1 Copies of MP Form 91 may be obtained, purposes only. The Meat Denaturing Guide without charge, by writing to the Adminis- has been approved for incorporation by ref- trative Operations Branch, Food Safety and erence by the Director, Office of the FED- Inspection Service, U.S. Department of Agri- ERAL REGISTER, and is on file at the FEDERAL culture, 123 East Grant Street, Minneapolis, REGISTER library.

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course of importation or otherwise in And provided further, That the product commerce any product unless the way- is transported to and from such ware- bill, transfer bill, running slip, conduc- house, and under official seal as pro- tor’s card, or other papers accompany- vided in § 325.5 and stored in such ing the same includes the signed state- rooms at such warehouse. ment in the following form: ———————————————————————— § 325.18 Diverting of shipments, break- (Name of transportation company) ing of seals, and reloading by car- U.S. inspected and passed, as evidenced by rier in emergency; reporting to Re- shipper’s certificate on file with initial car- gional Director. rier. (a) Shipments of inspected and passed (signed) ——————————————————— product that bear the inspection legend Agent may be diverted from the original des- (b) Signatures of agents to state- tination without a reinspection of the ments required under this section shall articles, provided the waybills, transfer be written in full. bills, running slips, conductor’s card, [47 FR 17276, Apr. 22, 1982] or other papers accompanying the shipments are marked, stamped, or have § 325.16 Official seals; forms, use, and attached thereto signed statements in breaking. accordance with § 325.15. (a) The official seals required by this (b) In case of wreck or similar ex- part shall be those prescribed in traordinary emergency, the Depart- § 312.5(a) of this subchapter. ment seals on a railroad car or other (b) Except as provided in § 325.18(b), means of conveyance containing any official seal affixed under this part inspected and passed product may be shall be affixed or broken only by Pro- broken by the carrier, and if necessary, gram employees, and no person other the articles may be reloaded into an- than a Program employee shall affix, other means of conveyance, or the detach, break, change, or tamper with shipment may be diverted from the any such seal in any way whatever. original destination, without another Commission of any such acts contrary shipper’s certificate; but in all such to this regulation is a criminal offense. cases the carrier shall immediately report the facts by telephone or tele- § 325.17 Loading or unloading prod- graph to the Regional Director in the ucts in sealed railroad cars, trucks, area in which the emergency occurs. etc., en route prohibited; exception. Such report shall include the following Unloading any product from an offi- information: cially sealed railroad car, truck, or (1) Nature of the emergency. other means of conveyance containing (2) Place where seals were broken. any unmarked product or loading any (3) Original points of shipment and product or any other commodity in the destination. means of conveyance while en route (4) Number and initial of the original from one official establishment to an- car or truck. other official establishment is not per- (5) Number and initials of the car or mitted, except that product trans- truck into which the articles are reported under § 325.5 from one official es- loaded. tablishment to another for further (6) New destination of the shipment. processing may be unloaded and stored (7) Kind and amount of articles. in transit at any approved warehouse [35 FR 15605, Oct. 3, 1970, as amended at 42 FR which is operated under the identifica- 39087, Aug. 2, 1977] tion service provided under the regulations in part 350 of subchapter B of this § 325.19 Provisions inapplicable to chapter and which has railroad facili- specimens for laboratory examina- ties or a receiving dock for unloading tion, etc., or to naturally inedible the product directly into such ware- articles. house: Provided, That the product is The provisions of this part do not stored in rooms which are of such size apply: and type as will not result in adultera- (a) To specimens of product sent to tion or misbranding of the product: or by the Department of Agriculture or

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divisions thereof in Washington, DC, or the Federal requirements for purposes elsewhere, for laboratory examination, of paragraph 301(c) of the Act; 4 exhibition purposes, or other official (c) Buy in commerce or import any use; dead, dying, disabled, or diseased live- (b) To material released for edu- stock or parts of the carcasses of any cational, research and other nonfood livestock that died otherwise than by purposes, as prescribed in § 314.9 of this slaughter, unless he is an animal food subchapter; manufacturer or renderer and is reg- (c) To glands and organs for use in istered as required by part 320 of this preparing pharmaceutical, subchapter, or is the operator of an es- organotherapeutic, or technical prod- tablishment inspected as required by ucts and not used for human food, as paragraph (b) of this section and such described in § 318.1(g) of this sub- livestock or parts of carcasses are to be chapter; delivered to establishments eligible to (d) To material or specimens of prod- receive them under paragraph (b) of uct for laboratory examination, re- this section; search, or other nonhuman food pur- (d) Unload en route to any establish- poses, when authorized by the Adminis- ment eligible to receive them under trator, and under conditions prescribed paragraph (b) of this section, any dead, by him in specific cases; and dying, disabled, or diseased livestock (e) To articles that are naturally in- or parts of the carcasses of any live- edible by humans, such as hoofs, horns, stock that died otherwise than by and hides in their natural state. slaughter, which are transported in commerce or imported by any such per- § 325.20 Transportation and other son: Provided, That any such dead, transactions concerning dead, dying, disabled, or diseased livestock, dying, disabled, or diseased live- or parts of carcasses may be unloaded stock, and parts of carcasses of live- from a means of conveyance en route stock that died otherwise than by where necessary in case of a wreck or slaughter. otherwise extraordinary emergency, No person engaged in the business of and may be reloaded into another buying, selling, or transporting in com- means of conveyance; but in all such merce, or importing any dead, dying, cases, the carrier shall immediately re- disabled or diseased animals or parts of port the facts by telegraph or tele- the carcasses of any animals that died phone to the Compliance Staff, Meat otherwise than by slaughter shall: and Poultry Inspection Field Oper- (a) Buy, sell, transport, or offer for ations, Food Safety and Inspection sale or transportation, in commerce, or Service, U.S. Department of Agri- import any dead livestock if its hide or culture, Washington, DC 20250. skin has been removed; (e) Load into any means of convey- (b) Sell, transport, offer for sale or ance containing any dead, dying, dis- transportation, or receive for transpor- abled, or diseased livestock, or parts of tation, in commerce, any dead, dying, the carcasses of any livestock that died disabled, or diseased livestock, or parts otherwise than by slaughter, while in of the carcasses of any livestock that the course of importation or other died otherwise than by slaughter, un- transportation in commerce any live- less such livestock and parts are con- stock or parts of carcasses not within signed and delivered, without avoidable delay, to establishments of animal food 4 A list of such registrants, States, and manufacturers, renderers, or collection amendments thereof, will be published in the stations that are registered as required Federal Register, and information concern- by part 320 of this subchapter, or to of- ing the registration status of particular ani- ficial establishments that operate mal food manufacturers, renderers, or collec- under Federal inspection, or to estab- tion stations, or the status of particular lishments that operate under a State States or Territories may also be obtained or Territorial inspection system ap- from the Director, Administrative Manage- ment Staff, Food Safety and Inspection proved by the Secretary as one that Service, U.S. Department of Agriculture, imposes requirements at least equal to Washington, DC 20250.

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the foregoing description or any other 327.6 Products for importation; program in- products or other commodities. spection, time, and place; application for approval of facilities as official import [35 FR 15605, Oct. 3, 1970, as amended at 42 FR inspection establishment; refusal or 42309, Aug. 23, 1977] withdrawal of approval; official numbers. 327.7 Products for importation; movement § 325.21 Means of conveyance in which prior to inspection; handling; bond; as- dead, dying, disabled, or diseased sistance. livestock and parts of carcasses 327.8 Import products; equipment and thereof shall be transported. means of conveyance used in handling to All vehicles and other means of con- be maintained in sanitary condition. veyance used by persons subject to 327.9 Burlap wrapping for foreign meat. § 325.20 for transporting in commerce or 327.10 Samples; inspection of consignments; refusal of entry; marking. importing, any dead, dying, disabled, 327.11 Receipts to importers for import and diseased livestock or parts of car- product samples. casses of livestock that died otherwise 327.12 Foreign canned or packaged products than by slaughter shall be leak-proof bearing trade labels; sampling and in- and so constructed and equipped as to spection. permit thorough cleaning and sanitiz- 327.13 Foreign products offered for importa- ing. The means of conveyance so used tion; reporting of findings to customs; in conveying such livestock, or parts handling of articles refused entry. 327.14 Marking of products and labeling of thereof, shall be cleaned and dis- immediate containers thereof for impor- infected prior to use in the transportation. tation of any product intended for use 327.15 Outside containers of foreign prod- as human food. The cleaning procedure ucts; marking and labeling; application shall include the complete removal of official inspection legend. from the means of conveyance of any 327.16 Small importations for importer’s fluid, parts, or product of such dead, own consumption; requirements. dying, disabled, or diseased livestock 327.17 Returned U.S. inspected and marked products. and the thorough application of a dis- 327.18 Products offered for entry and en- infectant to the interior surfaces of the tered to be handled and transported as cargo space. Substances permitted for domestic; exception. such use are: 327.19 Specimens for laboratory examina- (a) ‘‘Liquified phenol’’ (U.S.P. tion and similar purposes. strength 87 percent phenol) in the pro- 327.20 Importation of foreign inedible fats. portion of at least 6 fluid ounces to 1 327.21 Inspection procedures for chilled gallon of water. fresh and frozen boneless manufacturing (b) ‘‘Cresylic disinfectant’’ in the pro- meat. 327.22 [Reserved] portion of not less than 4 fluid ounces 327.23 Compliance procedure for cured pork to 1 gallon of water; and such other dis- products offered for entry. infectants as are approved by the Ad- 327.24 Appeals; how made. ministrator in specific cases. The use 327.25 Disposition procedures for product of ‘‘cresylic disinfectant’’ is permitted condemned or ordered destroyed under subject to the conditions prescribed in import inspection. § 71.10(b) of this title. 327.26 Official import inspection marks and devices. PART 327—IMPORTED PRODUCTS AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.18, 2.53. Sec. SOURCE: 35 FR 15610, Oct. 3, 1970, unless 327.1 Definitions; application of provisions. otherwise noted. 327.2 Eligibility of foreign countries for importation of products into the United § 327.1 Definitions; application of pro- States. visions. 327.3 No product to be imported without (a) When used in this part, the fol- compliance with applicable regulations. lowing terms shall be construed to 327.4 Imported products; foreign certificates mean: required. 327.5 Importer to make application for in- (1) Import (imported). To bring within spection of products for entry; informa- the territorial limits of the United tion required; ‘‘streamlined’’ inspection States whether that arrival is accom- procedures for Canadian product. plished by land, air, or water.

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(2) For product from eligible coun- § 327.2 Eligibility of foreign countries tries other than Canada: for importation of products into the (i) Offer(ed) for entry. The point at United States. which the importer presents the im- (a)(1) Whenever it shall be deter- ported product to the Program for rein- mined by the Administrator that the spection. system of meat inspection maintained (ii) Entry (entered). The point at by any foreign country, with respect to which imported product offered for establishments preparing products in entry receives reinspection and is such country for export to the United marked with the offical mark of in- States, insures compliance of such es- spection in accordance with § 327.26 of tablishments and their products with this subchapter. requirements equivalent to all the inspection, building construction stand- (3) For product from Canada: ards, and all other provisions of the (i) Offer(ed) for entry from establish- Act and the regulations in this sub- ments participating in the ‘‘stream- chapter which are applied to official es- lined’’ inspection procedures. The point tablishments in the United States, and at which an official of the Canadian their products, and that reliance can be meat inspection system contacts the placed upon certificates required under Import Field Office for an inspection this part from authorities of such for- assignment. eign country, notice of that fact will be (ii) Offer(ed) for entry from non- given by including the name of such participating establishments. The foreign country in paragraph (b) of this point at which the importer presents section. Thereafter, products prepared the imported product to the Program in such establishments which are cer- for reinspection. tified and approved in accordance with (iii) Entry (entered) for product not paragraph (a)(3) of this section, shall be subject to reinspection. When the con- eligible so far as this subchapter is containers or the products themselves if cerned for importation into the United not in containers are marked with the States from such foreign country after Canadian port stamp and upon the fil- applicable requirements of this sub- ing of Customs Form 7533 at the port of chapter have been met. (2) The determination of accept- entry or at the nearest customhouse in ability of a foreign meat inspection accordance with 19 CFR Part 123. system for purposes of this section (iv) Entry (entered) for product sub- shall be based on an evaluation of the ject to reinspection. When the contain- foreign program in accordance with the ers or the products themselves if not in following requirements and procedures: containers are marked with the Cana- (i) The system shall have a program dian export stamp and the foreign in- organized and administered by the na- spection certificate accompanying the tional government of the foreign coun- product is stamped as ‘‘Inspected and try. The system as implemented must Passed’’ by the import inspector. provide standards equivalent to those (b) The provisions of this part shall of the Federal system of meat inspec- apply to products derived from cattle, tion in the United States with respect sheep, swine, goats, horses, mules, and to: other equines, if capable of use as (A) Organizational structure and human food. Compliance with the con- staffing, so as to insure uniform en- ditions for importation of products forcement of the requisite laws and under this part does not excuse the regulations in all establishments need for compliance with applicable re- throughout the system at which prod- quirements under other laws, including ucts are prepared for export to the United States; the provisions in parts 94, 95, and 96 of (B) Ultimate control and supervision chapter I of this title. by the national government over the [35 FR 15610, Oct. 3, 1970, as amended at 36 FR official activities of all employees or 12004, June 24, 1971; 54 FR 41048, Oct. 5, 1989] licensees of the system;

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(C) The assignment of competent, (G) Official controls over condemned qualified inspectors; material until destroyed or removed (D) Authority and responsibility of and thereafter excluded from the estab- national inspection officials to enforce lishment; the requisite laws and regulations gov- (H) A Hazard Analysis and Critical erning meat inspection and to certify Control Point (HACCP) system, as set or refuse to certify products intended forth in part 417 of this chapter. for export; (I) Other matters for which require- (E) Adequate administrative and ments are contained in the Act or regu- technical support; lations in this subchapter. (F) The inspection, sanitation, qual- (iii) Countries desiring to establish ity, species verification, and residue eligibility for importation of product standards applied to products produced into the United States may request a in the United States. determination of eligibility by present- (G) Other requirements of adequate ing copies of the laws and regulations inspection service as required by the on which the foreign meat inspection regulations in this subchapter. system is based and such other information as the Administrator may re- (ii) The legal authority for the sys- quire with respect to matters enumer- tem and the regulations thereunder ated in paragraphs (a)(2) (i) and (ii) of shall impose requirements equivalent this section. Determination of eligi- to those governing the system of meat bility is based on a study of the docu- inspection organized and maintained in ments and other information presented the United States with respect to: and an initial review of the system in (A) Ante-mortem inspection of ani- operation by a representative of the mals for slaughter and inspection of Department using the criteria listed in methods of slaughtering and handling paragraphs (a)(2) (i) and (ii) of this sec- in connection with slaughtering which tion. Maintenance of eligibility of a shall be performed by veterinarians or country for importation of products by other employees or licensees of the into the United States depends on the system under the direct supervision of results of periodic reviews of the for- the veterinarians; eign meat inspection system in oper- (B) Post-mortem inspection of car- ation by a representative of the De- casses and parts thereof at time of partment, and the timely submission of slaughter, performed by veterinarians such documents and other information or other employees or licensees of the related to the conduct of the foreign system under the direct supervision of inspection system, including informa- veterinarians; tion required by paragraph (e) of sec- (C) Official controls by the national tion 20 of the Act, as the Administrator government over establishment con- may find pertinent to and necessary for struction, facilities, and equipment; the determinations required by this (D) Direct and continuous official su- section of the regulations. pervision of slaughtering and prepara- (iv) The foreign inspection system tion of product, by the assignment of must maintain a program to assure inspectors to establishments certified that the requirements referred to in under paragraph (a)(3) of this section, this section, equivalent to those of the to assure that adulterated or mis- Federal system of meat inspection in branded product is not prepared for ex- the United States, are being met. The port to the United States; program as implemented must provide (E) Complete separation of establish- for the following: ments certified under subparagraph (3) (A) Periodic supervisory visits by a of this paragraph from establishments representative of the foreign inspection not certified and the maintenance of a system not less frequent than one such single standard of inspection and sani- visit per month to each establishment tation throughout all certified estab- certified in accordance with paragraph lishments; (a)(3) of this section to assure that re- (F) Requirements for sanitation at quirements referred to in (A) through certified establishments and for sani- (H) of paragraph (a)(2)(ii) of this sec- tary handling of product; tion are being met: Provided, That such

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visits are not required with respect to establishment for importation of its any establishment during a period products into the United States if he when the establishment is not operat- has information that such establishing or is not engaged in producing ment does not comply with the require- products for exportation to the United ments listed in paragraphs (a)(2) (i) and States; (ii) of this section or if he cannot ob- (B) Written reports prepared by the tain current information concerning representative of the foreign inspection such establishment. The Administrator system who has conducted a super- will provide reasonable notice to the visory visit, documenting his or her foreign government of the proposed findings with respect to the require- termination of eligibility of any for- ments referred to in (A) through (H) of eign establishment for importation of paragraph (a)(2)(ii) of this section, cop- its products into the United States un- ies of which shall be made available to less, in his judgment, delay in termi- the representative of the Department nating its eligibility could result in the at the time of that representative’s re- importation of adulterated or mis- view upon request by that representa- branded product. Certifications of offi- tive to a responsible foreign meat in- cial establishments by the responsible spection official: Provided, That such official of the foreign meat inspection reports are not required with respect to system shall be in the following form: any establishment during a period when the establishment is not operat- FOREIGN OFFICIAL MEAT ESTABLISHMENT ing or is not engaged in producing CERTIFICATE products for exportation to the United I hereby certify that the establishment(s) States; and listed below fully comply (complies) with re- (C) Random sampling of internal or- quirements of (specify foreign country) gans and fat of carcasses at the point equivalent to all the inspection, building construction standards, and other require- of slaughter and the testing of such or- ments for the slaughter and preparation of gans and fat, for such residues having the carcasses, parts thereof, meat and meat been identified by the exporting coun- food products of cattle, sheep, swine, goats, try’s meat inspection authorities or by and equines applied to official establish- this Agency as potential contaminants, ments in the United States under the Fed- in accordance with sampling and ana- eral Meat Inspection Act and otherwise meet lytical techniques approved by the Ad- (meets) the requirements of § 327.2(a) of the ministrator: Provided, That such test- regulations governing meat inspection of the U.S. Department of Agriculture. ing is required only on samples taken from carcasses from which meat or Control numbers Name Address meat food products intended for importation into the United States are produced. (3) Only those establishments that are determined and certified to the De- partment by a responsible official of the foreign meat inspection system as Date ————————————————————— Signature ————————————————— fully meeting the requirements of Official Title ——————————————— paragraphs (a)(2) (i) and (ii) of this section are eligible to have their products (4) Product of cattle, sheep, swine, imported into the United States. Eligi- and goats from foreign countries not bility of certified establishments is listed in paragraph (b) of this section subject to review by the Department and product of equines from countries (including observations of the estab- not listed in paragraph (c) of this sec- lishments by Program representatives tion is not eligible for importation into at times prearranged with the officials the United States, except as provided of the foreign meat inspection system). by § 327.16 or § 327.17. The listing of any Certifications of establishments must foreign country under this section may be renewed annually. Notwithstanding be withdrawn whenever it shall be de- certification by a foreign official, the termined by the Administrator that Administrator may, at his discretion, the system of meat inspection main- terminate the eligibility of any foreign tained by such foreign country does

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not assure compliance with require- Sections Affected in the Finding Aids sec- ments equivalent to all the inspection, tion of this volume. building construction standards, and other requirements of the Act and the § 327.3 No product to be imported regulations in this subchapter as ap- without compliance with applicable plied to official establishments in the regulations. United States; or that reliance cannot (a) No product offered for importa- be placed upon certificates required tion from any foreign country shall be under this part from authorities of admitted into the United States if it is such foreign country; or that, for lack adulterated or misbranded or does not of current information concerning the comply with all the requirements of system of meat inspection being main- this subchapter that would apply to it tained by such foreign country, such if it were a domestic product. foreign country should be required to (b) No cooked or partially cooked reestablish its eligibility for listing. meat or meat trimmings, either in sep- (b) It has been determined that prod- arable pieces or molded into larger uct of cattle, sheep, swine, and goats forms, shall be permitted entry except from the following countries covered by foreign meat inspection certificates under the following conditions: of the country of origin as required by (1) A complete procedure for prepar- § 327.4, except fresh, chilled, or frozen ing and handling the product in the or other product ineligible for importa- foreign country and en route to the tion into the United States from coun- United States shall be submitted by tries in which the contagious and com- the exporter or his authorized agent to municable disease of rinderpest or of the Administrator and determined by foot-and-mouth disease or of African the Administrator to be adequate to swine fever exists as provided in part 94 assure that the product will not be of this title, is eligible under the regu- adulterated or misbranded at the time lations in this subchapter for entry of offer for entry. into the United States after inspection (2) A system acceptable to the Ad- and marking as required by the appli- ministrator (upon his determination cable provisions of this part. that the system will provide a reliable Argentina, Australia, Austria, Belgium, indication of the kinds and numbers of Belize, Brazil, Canada, Costa Rica, Czech microorganisms present) for the micro- Republic, Denmark, Dominican Republic, biological testing of the finished prod- El Salvador, England and Wales, Finland, uct shall be installed by the processor, France, Germany (Federal Republic), Gua- temala, Honduras, Hungary, Iceland, Ire- the product is subjected to such test- land (Eire), Italy, Japan, Mexico, Nether- ing, and the results thereof are fur- lands, New Zealand, Nicaragua, Northern nished to the Administrator and are Ireland, Norway, Paraguay, Poland, Repub- acceptable to him as showing that the lic of China, (Taiwan), Republic of Croatia, product has been prepared and handled Republic of Slovenia, Romania, Scotland, in a sanitary manner. Spain, Sweden, Switzerland, Uruguay, Ven- ezuela, Yugoslavia. (c) [Reserved] (c) It has been determined that prod- [35 FR 15610, Oct. 3, 1970, as amended at 38 FR uct of equines from the following coun- 29215, Oct. 23, 1973; 54 FR 41048, Oct. 5, 1989; 56 tries, covered by foreign meat inspec- FR 38335, Aug. 13, 1991; 57 FR 27906, June 23, tion certificates of the country of ori- 1992] gin as required by § 327.4, is eligible § 327.4 Imported products; foreign cer- under the regulations in this sub- tificates required. chapter for importation into the Unit- ed States after inspection and marking (a) Except as provided in § 327.16, each as required by the applicable provisions consignment containing any fresh of this part. meat or fresh meat byproducts consigned to the United States from a for- Argentina, Canada, New Zealand, Paraguay. eign country shall be accompanied by a [35 FR 15610, Oct. 3, 1970] foreign-meat-inspection certificate for EDITORIAL NOTE: For FEDERAL REGISTER ci- fresh meat and meat byproducts in the tations affecting § 327.2, see the List of CFR following form:

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ORIGINAL slaughter in plants certified for importation of their products into the United States, OFFICIAL MEAT-INSPECTION CERTIFICATE FOR were handled in a sanitary manner, and were FRESH MEAT AND MEAT BYPRODUCTS prepared under the continuous supervision of Place —————— (City) —————— (Coun- an inspector under control of the national try) Date ——— meat inspection system and that said meat food products are not adulterated or mis- I hereby certify that the meat and meat branded as defined by the regulations gov- byproducts herein described were derived erning meat inspection of the U.S. Depart- from livestock which received ante-mortem ment of Agriculture, and are otherwise in and post-mortem veterinary inspections at compliance with requirements equivalent to time of slaughter in plants certified for im- those in the Federal Meat Inspection Act and portation of their products into the United said regulations. States and are not adulterated or mis- I further certify that all products herein branded as defined by the regulations gov- described that are prepared customarily to erning meat inspection of the U.S. Depart- be eaten without cooking and contain mus- ment of Agriculture; and that said products cle tissue of pork were treated for destruc- have been handled in a sanitary manner in tion of trichnae as prescribed in § 318.10 of this country and are otherwise in compliance the Meat Inspection Regulations of the U.S. with requirements equivalent to those in the Department of Agriculture. Federal Meat Inspection Act and said regulations. Species of live- Number of Kind of product stock derived pieces or Weight Species of live- Number of from containers Kind of product stock derived pieces or Weight from containers

Identification marks on products and containers ——————————————————— Identification marks on products and containers ——————————————————— Consignor —————————————————— Address ——————————————————— Consignor —————————————————— Establishment number ——————————— Address ——————————————————— Consignee —————————————————— Establishment number ——————————— Destination ————————————————— Consignee —————————————————— Shipping marks ——————————————— Destination ————————————————— (Signature) ————————————————— Shipping marks ——————————————— (Name of official authorized by the national (Signature) ————————————————— foreign government to issue inspection cer- (Name of official authorized by the national tificates for meat food product exported to foreign government to issue inspection cer- the United States) tificates for meat and meat byproducts ex- (Official title) ———————————————— ported to the United States) (Official title) ———————————————— (c) Each foreign meat-inspection certificate shall bear the official seal of (b) Except as provided in § 327.16, each the national government agency re- consignment containing any meat food sponsible for the inspection of the product consigned to the United States product and be signed and issued by an from a foreign country shall be accom- official authorized to sign and issue panied by a foreign-meat-inspection such certificates by the national gov- certificate for meat food products in ernment of the foreign country in the following form: which the product is inspected. ORIGINAL (d) Each foreign meat-inspection certificate shall be in both the English OFFICIAL MEAT-INSPECTION CERTIFICATE FOR language and the language of the for- MEAT FOOD PRODUCTS eign country of origin. Place —————— (City) —————— (Coun- (e) Except for product subject to pro- try) —————— Date ——— cedures in § 327.5(d)(l), the foreign meat I hereby certify that the meat food prod- inspection certificate required by this ucts herein described were derived from live- section to accompany each consign- stock which received ante-mortem and post- ment containing any product shall be mortem veterinary inspections at time of delivered by the consignee, or his

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agent, in the United States to the Pro- (2) If the AIIS designates the consign- gram import inspector at the place of ment for reinspection, the representa- inspection, and inspection of the prod- tive shall: uct will not be commenced prior to (i) Select samples in accordance with such delivery. USDA sampling tables.3 (ii) Identify and place samples in the [35 FR 15610, Oct. 3, 1970, as amended at 54 FR 274, Jan. 5, 1989; 60 FR 38668, July 28, 1995] vehicle for easy removal and reinspection by an import inspector. § 327.5 Importer to make application (3) In the event that any one of the for inspection of products for entry; requirements provided in (d)(2) of this information required; ‘‘streamlined’’ section is not met, reinspection of the inspection procedures for Canadian consignment shall be conducted by a product. Program import inspector in accord- (a) Except for importers of Canadian ance with established procedures pro- products, each importer shall apply for vided in the regulations for other im- inspection of any product offered for ported products. entry by contacting the Import Field [54 FR 274, Jan. 5, 1989, as amended at 54 FR Office covering the location where im- 41048, Oct. 5, 1989] port inspection will take place. The Import Field Office will provide spe- § 327.6 Products for importation; pro- cific application instructions (See gram inspection, time and place; § 301.2 (yyy)). application for approval of facilities as official import inspection estab- (b) The application should be made as lishment; refusal or withdrawal of long as possible in advance of the an- approval; official numbers. ticipated arrival of each consignment, except in case of consignments of prod- (a)(1) Except as provided in ucts expressly exempted from inspec- §§ 327.5(d)(1), 327.16 and 327.17, all products offered for entry from any foreign tion by §§ 327.16 and 327.17, and in the country shall be reinspected by a Pro- case of product imported from Canada. gram inspector before they shall be al- (c) Except in the case of product im- lowed entry into the United States. ported from Canada, each application (2) Every lot of product shall rou- shall state the approximate date on tinely be given visual inspection by a which the consignment is due to arrive Program import inspector for appear- at such port in the United States, the ance and condition, and checked for name of the ship or other carrier trans- certification and label compliance, exporting it, the name of the country cept as provided in 327.5(d)(1). from which the product was, or is to (3) The computerized Automated Im- be, shipped, the place where inspection port Information System (AIIS) shall is desired in accordance with § 327.6, the be consulted for reinspection instruc- quantity and kind of product, and tions. The AIIS will assign reinspection whether it is fresh, cured, canned or levels and procedures based on estab- otherwise prepared. In case of consign- lished sampling plans or established ments arriving in the United States by sampling plans and established product water, the application shall also state and plant history. the port of first arrival in the United (4) When the inspector deems it nec- States. essary, the inspector may sample and (d) For participating Canadian estab- inspect lots not designated by AIIS. lishments, an official of the Canadian (b) All products, required by this part meat inspection system shall contact to be inspected, shall be inspected only the participating Import Field Office at an official establishment or at an of- for an inspection assignment (See ficial import inspection establishment § 301.2 (yyy)). (1) If the Automated Import Informa- 3 A copy of the sampling tables is available, tion System (AIIS) does not designate upon request, from the Import Inspection Di- the consignment for reinspection, the vision, International Programs, Food Safety consignment may be transported to its and Inspection Service, U.S. Department of consignee for further distribution. Agriculture, Washington, DC 20250.

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approved by the Administrator as pro- (f) The Administrator is authorized vided in this section. Such approved of- to approve any establishment as an official import inspection establishments ficial import inspection establishment will be listed in the Directory of Meat provided that an application has been and Poultry Inspection Program Estab- filed and drawings have been submitted lishments, Circuits and Officials, pub- in accordance with the requirements of lished by the Food Safety and Inspec- paragraphs (c) and (d) of this section tion Service. The listing will cat- and he determines that such establish- egorize the kind or kinds of product 2 ment meets the requirements under which may be inspected at each official paragraph (e) of this section. If it is de- import inspection establishment, based termined that the establishment does on the adequacy of the facilities for not meet such requirements, approval making such inspections and handling of the establishment as an official im- such products in a sanitary manner. port inspection establishment may be (c) Owners or operators of establish- refused in accordance with the applica- ments, other than official establish- ble rules of practice. A written notice, ments, who want to have import in- specifying the premises to which the spections made at their establish- approval applies, shall be given to each ments, shall apply to the Adminis- applicant granted approval. When ap- trator for approval of their establish- proval is refused for any such reason, ments for such purpose. Application the applicant shall be informed of the shall be made on a form furnished by action and the reason therefor. Ap- the Program, Food Safety and Inspec- proval may also be refused in accord- tion Service, U.S. Department of Agri- ance with section 401 of the act and ap- culture, Washington, DC, and shall in- plicable rules of practice. clude all information called for by that (g) Approval of an official import inform. spection establishment may be with- (d) Each applicant seeking approval drawn in accordance with applicable of his establishments for import in- rules of practice if it is determined spections shall submit to the Adminis- that the sanitary conditions are such trator necessary drawings with speci- that the product is rendered adulter- fications to determine compliance with ated, that such action is authorized by the requirements of this section. Ap- section 21(b) of the Federal Water Pol- proval shall be sought in accordance lution Control Act, as amended (84 with § 304.2(a) of this subchapter. Sub- Stat. 91), or that the requirements of mission of drawings is not required if paragraph (e) of this section were not the applicant’s establishments are op- complied with. Approval may also be erated under a State inspection pro- withdrawn in accordance with section gram in a State not listed in § 331.2 of 401 of the Act and applicable rules of this subchapter. practice. (e) Owners or operators of establish- (h) A special official number shall be ments at which import inspections of assigned to each official import inspec- product are to be made shall furnish tion establishment. Such number shall adequate sanitary facilities and equip- be used to identify all products in- ment for examination of such product. spected and passed for entry at the es- The requirements of §§ 304.2(e), 307.1, tablishment. 307.2 (b), (d), (f), (h), (k), and (l) and (i) A sampling inspection shall be 308.3, 308.4, 308.5, 308.6, 308.7, 308.8, 308.9, made, as provided in paragraph (a) of 308.11, 308.13, 308.14, and 308.15 of this this section, of foreign chilled fresh or subchapter shall apply as conditions frozen fresh meat, including defrosting for approval of establishments as offi- if necessary to determine its condition. cial import inspection establishments Inspection standards for foreign chilled to the same extent and in the same fresh or frozen fresh meat shall be the manner as they apply with respect to same as those used for domestic chilled official establishments. fresh or frozen fresh meat. (See § 327.21) (j) Imported canned products are re- 1 [Reserved] quired to be sound, healthful, properly 2 For example: Canned product, boneless labeled, wholesome, and otherwise not meat, carcasses and cuts. adulterated at the time the products

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are offered for importation into the Service, U.S. Department of Agri- United States. Provided other require- culture, Washington, DC 20250. ments of this Part are met, the deter- [35 FR 15610, Oct. 3, 1970, as amended at 37 FR mination of the acceptability of the 21927, Oct. 17, 1972; 38 FR 29215, Oct. 23, 1973; product and the condition of the con- 49 FR 36818, Sept. 20, 1984; 51 FR 37707, Oct. tainers shall be based on the results of 24, 1986; 51 FR 45633, Dec. 19, 1986; 54 FR 274, an examination of a statistical sample Jan. 5, 1989; 54 FR 41048, Oct. 5, 1989] drawn from the consignment as provided in paragraph (a) of this section. If § 327.7 Products for importation; the inspector determines, on the basis movement prior to inspection; handling; bond; assistance. of the sample examination, that the product does not meet the require- (a) No product required by this part ments of the Act and regulations there- to be inspected shall be moved, prior to under, the consignment shall be reinspection from any port, or, if arriv- fused entry. However, a consignment ing by water from the wharf where first rejected for container defects but oth- unloaded, to any place other than the erwise acceptable may be reoffered for place designated by, or in accordance with, this part as the place where the inspection under the following condi- same shall be inspected. tions: (b) No product required by this part (1) If the defective containers are not to be inspected shall be conveyed, prior indicative of an unsafe and unstable to inspection, from any port, or, if ar- product as determined by the Adminis- riving by water, from the wharf where trator; first unloaded, in any manner other (2) If the number and kinds of con- than in compliance with this part. tainer defects found in the original (c) No product required by this part sample do not exceed the limits speci- to be inspected shall be delivered to fied for this purpose in FSIS guide- the consignee or his agent prior to in- lines; and spection, unless the consignee shall (3) If the defective containers in the furnish a bond, in form prescribed by consignment have been sorted out and the Secretary of the Treasury, condi- exported or destroyed under the super- tioned that the product shall be re- vision of an inspector. turned, if demanded, to the collector of (k) Program inspectors or Customs the port where the same is offered for officers at border or seaboard ports clearance through the customs. shall report the sealing of cars, trucks, (d) The consignee or his agent shall or other means of conveyance, and the provide such assistance as Program in- sealing or identification of containers spectors may require for the handling of foreign product on Form MP–410 to and marking of product offered for Program area supervisors at points entry. where such product is to be inspected. [35 FR 15610, Oct. 3, 1970, as amended at 37 FR (l) Representative samples of canned 21928, Oct. 17, 1972; 51 FR 37707, Oct. 24, 1986; product designated by the Adminis- 56 FR 65180, Dec. 16, 1991] trator in instructions to inspectors shall be incubated under supervision of § 327.8 Import products; equipment such inspectors in accordance with and means of conveyance used in handling to be maintained in sani- § 318.309 (d)(1)(ii), (d)(1)(iii), (d)(1)(iv)(c), tary condition. (d)(1)(v), (d)(1)(vii) and (d)(1)(viii) of this subchapter. The importers or his/ Compartments of steamships, sailing her agent shall provide the necessary vessels, railroad cars, and other means incubation facilities in accordance of conveyance transporting any product to the United States, and all with § 318.309(d)(1)(i) of this subchapter. trucks, chutes, platforms, racks, ta- (m) Sampling plans and acceptance bles, tools, utensils, and all other de- levels as prescribed in paragraphs (j) vices used in moving and handling any and (l) of this section may be obtained, product offered for importation into upon request, from International Pro- the United States, shall be maintained grams, Food Safety and Inspection in a sanitary condition.

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§ 327.9 Burlap wrapping for foreign where the inspection is to be per- meat. formed. Burlap shall not be used as a wrap- (1) The written procedure for con- ping for foreign meat unless the meat trolled pre-stamping should be in the is first wrapped with a good grade of form of a letter and shall include the paper or cloth of a kind which will pre- following: vent contamination with lint or other (i) That stamping under this part will foreign material. be limited to those lots of product which can be inspected on the day that § 327.10 Samples; inspection of con- certificates for the product are exam- signments; refusal of entry; mark- ined; ing. (ii) That all product which has been (a) Program inspectors may take, pre-stamped will be stored in the facil- without cost to the United States, for ity where the import inspection will laboratory examination, samples of occur; any product which is subject to analy- (iii) That inspection marks applied sis, from each consignment offered for under this part will be removed from importation, except that such samples any lot of product subsequently refused shall not be taken of any product of- entry on the day the product is re- fered for importation under § 327.16. jected; and (b) Except for product offered for (iv) That the establishment will entry from Canada, the outside con- maintain a daily stamping log contain- tainers of all products offered for entry ing the following information for each from any foreign country and accom- lot of product: the date of inspection, panied with a foreign inspection cer- the country of origin, the foreign es- tificate as required by this part, which, tablishment number, the product upon reinspection by import inspectors name, the number of units, the ship- are found not to be adulterated or mis- ping container marks, and the MP–410 branded and are otherwise eligible for number covering the product to be in- entry into the United States under this spected. The daily stamping log must part, or the products themselves if not be retained by the establishment in ac- in containers, shall be marked with the cordance with the requirements of official inspection legend prescribed in § 320.3. § 327.26 of this part. Except for Cana- (2) An establishment’s controlled pre- dian product, all other products so stamping privilege may be cancelled marked, in compliance with this part, orally or in writing by the inspector shall be entered into the United States, who is supervising its enforcement insofar as such entry is regulated whenever the inspector finds that the under the Act. establishment has failed to comply (c) Product which is inspected and re- with the provisions of this part or any jected shall be marked ‘‘U.S. Refused conditions imposed pursuant thereto. If Entry’’ as shown in § 327.26(c). Such the cancellation is oral, the decision marks shall be applied to the shipping and the reasons therefor shall be con- container or the product itself if not in firmed in writing, as promptly as cir- a container. cumstances allow. Any person whose (d) The inspection legend may be controlled pre-stamping privilege has placed on containers of product before been cancelled may appeal the decision completion of official import inspec- to the Administrator, in writing, with- tion if the containers are being in- in ten (10) days after receiving written spected by an import inspector who re- notification of the cancellation. The ports directly to an Import Field Office appeal shall state all of the facts and Supervisor; the product is not required reasons upon which the person relies to to be held at the establishment pending show that the controlled pre-stamping the receipt of laboratory test results; privilege was wrongfully cancelled. The and a written procedure for controlled Administrator shall grant or deny the stamping, submitted by the import es- appeal, in writing, stating the reasons tablishment and approved by the Direc- for such decision, as promptly as cir- tor, Import Inspection Division, is on cumstances allow. If there is a conflict file at the import inspection facility as to any material fact, a hearing shall

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be held to resolve such conflict. Rules customs’ bond pending the report of of practice concerning such a hearing laboratory findings. will be adopted by the Administrator. (c) Samples shall be taken from for- The cancellation of the controlled pre- eign canned products or packaged prod- stamping privilege will be in effect ucts as required by § 327.6 (a) and (j) of until there is a final determination of this part. the proceeding. [35 FR 15610, Oct. 3, 1970, as amended at 49 FR (Approved by the Office of Management and 36818, Sept. 20, 1984] Budget under control number 0583–0015) § 327.13 Foreign products offered for [35 FR 15610, Oct. 3, 1970, as amended at 53 FR importation; reporting of findings 17014, May 13, 1988; 54 FR 41048, Oct. 5, 1989] to customs; handling of articles refused entry. § 327.11 Receipts to importers for import product samples. (a)(1) Program inspectors shall report their findings as to any product which In order that importers may be as- has been inspected in accordance with sured that samples of foreign products this part, to the Director of Customs at collected for laboratory examination the original port of entry where the are to be used exclusively for that pur- same is offered for clearance through pose, official receipts shall be issued Customs inspection. and delivered to importers, or their (2) When product has been identified agents, by inspectors for all samples of as ‘‘U.S. refused entry, ’’ the inspector foreign products collected. The official shall request the Director of Customs receipt shall be prepared in duplicate, to refuse admission to such product over the signature of the inspector who and to direct that it be exported by the collects the samples, and shall show owner or consignee within the time the name of the importer, country of specified in this section, unless the origin, quantity and kind of product owner or consignee, within the speci- collected, date of collection, and that fied time, causes it to be destroyed by the sample was collected for laboratory disposing of it under the supervision of examination. The duplicate copy of the a Program employee so that the prod- receipt shall be retained by the inspec- uct can no longer be used as human tors as their office record. food, or by converting it to animal food [35 FR 15610, Oct. 3, 1970, as amended at 51 FR uses, if permitted by the Food and 37707, Oct. 24, 1986] Drug Administration. The owner or consignee of the refused entry product § 327.12 Foreign canned or packaged shall not transfer legal title to such products bearing trade labels; sam- product, except to a foreign consignee pling and inspection. for direct and immediate exportation, (a) Samples of foreign canned or or to an end user, e.g., an animal food packaged products bearing on their im- manufacturer or a renderer, for de- mediate containers trade labels which struction for human food purposes. have not been approved under § 317.3 of ‘‘Refused entry’’ product must be deliv- this subchapter shall be collected and ered to and used by the manufacturer forwarded to the laboratory by the or renderer within the 45-day time Program inspector for examination, limit. Even if such title is illegally and the products shall be held pending transferred, the subsequent purchaser receipt of the report of the laboratory will still be required to export the findings and the results of the exam- product or have it destroyed as speci- ination of trade labels and the marks fied in the notice under paragraph on shipping containers. (a)(5) of this section. (b) Foreign canned or packaged prod- (3) No lot of product which has been ucts bearing trade labels and other refused entry may be subdivided during markings which have been approved disposition pursuant to paragraph under § 317.3 of this subchapter shall be (a)(2) of this section, except that reinspected for soundness and checked moval and destruction of any damaged for net weight. Samples may be col- or otherwise unsound product from a lected for laboratory examination, but lot destined for reexportation is per- the products may be released under mitted under supervision of USDA

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prior to exportation. Additionally, shall, at the consignee’s own expense, such refused entry lot may not be immediately return to the Director shipped for export from any port other any product which has been delivered than that through which the product to consignee under § 327.7 and subse- came into the United States, without quently designated ‘‘U.S. Refused the expressed consent of the Adminis- Entry’’ or found in any respect not to trator based on full information con- comply with the requirements in this cerning the product’s disposition, in- part. cluding the name of the vessel and the (c) All charges for storage, cartage, date of export. For the purposes of this and labor with respect to any product paragraph, the term ‘‘lot’’ shall refer which was imported contrary to the to that product indentified on MP Act shall be paid by the owner or con- Form 410 in the original request for in- signee, and in default of such payment spection for importation pursuant to shall constitute a lien against such § 327.5. product and any other product there- (4) Product which has been refused after imported by or for such owner or entry solely because of misbranding, in consignee. lieu of exportation or destruction pur- [35 FR 15610, Oct. 3, 1970, as amended at 48 FR suant to paragraph (a)(2) of this sec- 15889, Apr. 13, 1983; 49 FR 29568, July 23, 1984; tion, may be brought into compliance 50 FR 19907, May 13, 1985; 53 FR 17015, May 13, with the requirements of this part, 1988; 54 FR 50735, Dec. 11, 1989] under supervision of an authorized representative of the Administrator. § 327.14 Marking of products and la- (5) The owner or consignee shall have beling of immediate containers 45 days after notice is given by FSIS to thereof for importation. the Director of Customs at the original (a) Product which is offered for import of entry to take the action re- portation, and which is susceptible of quired in paragraph (a)(2) of this sec- marking, shall, whether or not en- tion for ‘‘refused entry’’ product. Ex- closed in an immediate container, bear tension beyond the 45-day period may the name of the country of origin, pre- be granted by the Administrator when ceded by the words ‘‘product of’’; the extreme circumstances warrant it; e.g., establishment number assigned by the a dock workers’ strike or an unforesee- foreign meat inspection system and able vessel delay. certified to the Program; and such (6) If the owner or consignee fails to other markings as are necessary for take the required action within the compliance with part 316 of this sub- time specified under paragraph (a)(5) of chapter. When such markings are im- this section, the Department will take prints of stamps or brands made with such action as may be necessary to ef- branding ink, such ink shall be harm- fectuate its order to have the product less and shall create permanent im- destroyed for human food purposes. prints. In case the name of the country The Department shall seek court costs of origin appears as part of an official and fees, storage, and proper expense in mark of the national foreign govern- the appropriate legal forum. ment and such name is prominently (7) No product which has been refused and legibly displayed, the words ‘‘prod- entry and exported to another country uct of’’ may be omitted. pursuant to paragraph (a)(2) of this sec- (b) In addition to the marking of tion may be returned to the United products required under paragraph (a) States under any circumstance. Any of this section, the immediate con- such product so returned to the United tainer of any product offered for impor- States shall be subject to administra- tation: tive detention in accordance with sec- (1) Shall bear a label showing in action 402 of the Act and seizure and con- cordance with § 317.2 of this subchapter demnation in accordance with section all information required by that sec- 403 of the Act. tion (except that the establishment (b) Upon the request of the Director number assigned by the foreign meat of Customs at the port where a product inspection system and certified to the is offered for clearance through the Program and the official inspection customs, the consignee of the product mark of the foreign meat inspection

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system shall be shown instead of the (1) The name or descriptive designa- official inspection legend of the United tion of the product in accordance with States) and in addition the name of the § 317.2 of this subchapter; country of origin preceded by the (2) The name of the country of origin; words ‘‘product of,’’ immediately under and the name or descriptive designation of (3) The establishment number as- the product as required by § 317.2: Pro- signed by the foreign meat inspection vided, That such establishment number system and certified to the Program. may be omitted from a label (b) All labeling used with an outside lithographed directly on a can if said container of foreign product must be number is lithographed or embossed approved in accordance with Part 317 of elsewhere on the can; and this subchapter. (2) Shall, if such immediate con- (c) Except for product offered for tainer is a sealed metal container, have entry from Canada, all outside contain- the establishment number assigned by the foreign meat inspection authority ers of products which have been in- and certified by the Program embossed spected and passed in accordance with or lithographed on the sealed metal this part shall be marked by a Program container, and such establishment import inspector or under a Program number shall not be covered or ob- import inspector’s supervision with the scured by any label or other means. official import meat inspection mark (c) All marks and other labeling for prescribed in § 327.26. use on or with immediate containers, [35 FR 15610, Oct. 3, 1970, as amended at 51 FR as well as private brands on carcasses 37707, Oct. 24, 1986; 54 FR 41048, Oct. 5, 1989] or parts of carcasses, shall be approved by the Food Safety and Inspection § 327.16 Small importations for import- Service in accordance with part 317 of er’s own consumption; require- this subchapter before products bearing ments. such marks, labeling, or brands will be Any product in a quantity of 50 entered into the United States. The pounds or less which was purchased by marks of inspection of foreign systems the importer outside the United States embossed on metal containers or for his/her own consumption, is eligible branded on carcasses or parts thereof to be imported into the United States need not be submitted to the Food from any country without compliance Safety and Inspection Service for ap- with the provisions in other sections of proval, and such marks of inspection this part but subject to applicable re- put on stencils, box dies, labels, and quirements under other laws, including brands may be used on such immediate the regulations in Part 94 of this title. containers as tierces, barrels, drums, However, Program employees may in- boxes, crates, and large-size fiberboard containers of foreign products without spect any product imported under this such marks of inspection being submit- section to determine whether it is ted for approval, provided the mark- within the class eligible to be imported ings made by such articles are applica- under this paragraph. ble to the product and are not false or [54 FR 41048, Oct. 5, 1989] misleading. [35 FR 15610, Oct. 3, 1970, as amended at 51 FR § 327.17 Returned U.S. inspected and 37707, Oct. 24, 1986; 60 FR 67456, Dec. 29, 1995] marked products. U.S. inspected and passed and so § 327.15 Outside containers of foreign marked products exported to and re- products; marking and labeling; ap- turned from foreign countries will be plication of official inspection legend. admitted into the United States without compliance with this part upon no- (a) The outside container in which tification to and approval of the Dep- any immediate container of foreign uty Administrator, International Pro- product is shipped to the United States grams, Food Safety and Inspection shall bear, in English, in a prominent and legible manner:

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Service, U.S. Department of Agri- § 316.15 of this subchapter or unless it is culture, Washington, DC 20250, in spe- identified and handled as prescribed by cific cases. § 325.11 (b) or (c) of this subchapter. [35 FR 15610, Oct. 3, 1970, as amended at 51 FR 37707, Oct. 24, 1986] [54 FR 41049, Oct. 5, 1989]

§ 327.18 Products offered for entry and § 327.21 Inspection procedures for entered to be handled and trans- chilled fresh and frozen boneless ported as domestic; exception. manufacturing meat. (a) All products, after entry into the (a) Definitions; sampling; standards. (1) United States, shall be deemed and Frozen boneless manufacturing meat is treated as domestic products and shall meat, frozen in the fresh state from be subject to the applicable provisions cattle, sheep, swine, goats, horses, of the Act and the regulations in this mules, or other equines that has all subchapter and the applicable require- bone removed and is cut into pieces or ments under the Federal Food, Drug trimmings, frozen into a compact and Cosmetic Act, except that products block of any shape and suitable for imported under § 327.16 are required to comply only with the requirements of slicing or chopping in the manufactur- that Act and § 327.16 of this subchapter. ing of meat food products. As used in (b) Products entered in accordance this section, the term ‘‘frozen’’ in- with this part may, subject to the pro- cludes ‘‘chilled fresh,’’ and ‘‘lot’’ means visions of part 318 of this subchapter, any amount of frozen boneless manu- be taken into official establishments facturing meat of one species, simi- and be mixed with or added to any larly packaged, shipped from one es- product in such establishments which tablishment, and offered for import in- has been inspected and passed therein. spection under one or more foreign in- (c) Imported product which has been spection certificates. inspected, passed, and marked under (2) Imported frozen boneless manu- this part may be transported in the facturing meat shall be sampled as re- course of importation or subsequently quired by § 327.6(a) of this part, and the in commerce only upon compliance samples defrosted for inspection. The with part 325 of this subchapter. Program import inspector, or in the [35 FR 15610, Oct. 3, 1970, as amended at 41 FR case of Canadian product subject to 18089, Apr. 30, 1976; 54 FR 41049, Oct. 5, 1989] procedures described in § 327.5(d)(1), the Canadian representative will select § 327.19 Specimens for laboratory examination and similar purposes. from a lot the appropriate number of cartons specified by the table of sam- The provisions in this part do not pling plans. The total sample for in- apply to specimens of products for lab- spection will consist of the necessary oratory examination, research, or similar purposes when authorized importa- number of 12-pound units drawn from tion by the Administrator under condi- these cartons. The 12-pound units se- tions specified by him in specific cases, lected will be completely defrosted and including requirements of denaturing examined. or other identification to deter their (b) Lots refused entry. Reinspection use for human food. Authorization will (including resampling) will be provided not be given for the importation of any for any lot of frozen boneless manufac- products contrary to the provisions of turing meat which was refused entry part 94 of this chapter. under this section on the basis of the original evaluation of the sample § 327.20 Importation of foreign ined- thereof, upon appeal from the inspec- ible fats. tor’s initial decision. No inedible grease, inedible tallow, or other inedible rendered fat shall be [35 FR 15610, Oct. 3, 1970, as amended at 49 FR imported into the United States unless 36819, Sept. 20, 1984; 51 FR 44901, Dec. 15, 1986; it has been first denatured as pre- 54 FR 275, Jan. 5, 1989; 57 FR 27906, June 23, 1992] scribed in § 327.25 of this part and the containers marked as prescribed by

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§ 327.22 [Reserved] of an individual sample for PFF content be below the applicable minimum § 327.23 Compliance procedure for requirement of § 319.104 or § 319.105 of cured pork products offered for this subchapter by 2.3 or more percent- entry. age points for a Group I or II product (a) Definitions. For the purposes of or 2.7 or more percentage points for a this section: Group III or IV product. (1) A Product is that cured pork arti- (6) A PFF Standardized Arithmetic Av- cle which is contained within one erage of the Country’s Products is the Group as defined in paragraph (a)(2) of arithmetic average of PFF Standard- this section and which purports to ized Differences from either 36 or 100 meet the criteria for a single product consecutively sampled lots of product designated under the heading ‘‘Product entering the United States from a Name and Qualifying Statements’’ in the chart in § 319.104 or § 319.105 of this given producing country. subchapter. (7) A PFF Standardized Weighted Aver- (2) A Product Group or a Group means age of the Country’s Products is an esti- one of the following: mate of the average of the PFF Stand- (i) Group I, consisting of cured pork ardized Differences from either 36 or products which have been cooked while 100 consecutively sampled lots, ad- imperviously encased. Any product justed for the size of the lot, of dif- that fits into the Group shall be placed ferent types of cured pork product en- in this Group regardless of any other tering the United States from a given considerations. producing country. A Standardized (ii) Group II, consisting of cured pork Weighted Average is computed by mul- products which have been water tiplying the PFF Standardized Dif- cooked. Any product that does not fit ference calculated for each lot by the into Group I but does fit into Group II number of pounds of product in each shall be placed into Group II regardless lot, adding those results together, and of any other considerations. dividing the sum by the total weight of (iii) Group III, consisting of boneless, product from all the lots making up smokehouse heated cured pork prod- the average. ucts. Any boneless product that does (8) The Appropriate Standard Deviation not fit into Group I or II shall be is based on within lot variability. That placed in Group III. assigned to Groups I and II = 0.75 per- (iv) Group IV, consisting of bone-in cent PFF and that assigned to Groups or semi-boneless smokehouse heated III and IV = 0.91 percent PFF. cured pork products. Any product that (9) A Lot is all product of one type is not completely boneless or still con- from one establishment presented by tains all the bone which is traditional an importer as the unit for inspection for bone-in product and does not fit at the Port of Entry. into Group I, II, or III shall be placed in this Group. (b) Normal monitoring procedures. Ex- (3) Protein Fat-Free Percentage, Protein cept for product imported from Canada, Fat-Free Content, PFF Percentage, PFF the Department shall collect sample(s) Content or PFF of a product means the of cured pork product on a random meat protein (indigenous to the raw, basis from lots offered for entry at the unprocessed pork cut) content ex- Port of Entry and, after analyzing the pressed as a percent of the non-fat por- sample for fat and indigenous protein tion of the finished product. content, calculate the PFF percentage. (4) A PFF Standardized Difference is The product shall not be held pending the PFF of the sample minus the mini- laboratory results during the monitor- mum PFF requirement, set forth in ing phase. The PFF percentage for each § 319.104 and § 319.105 of this subchapter, sample shall be considered along with for the product being analyzed, divided the cumulative results of prior samples by the Appropriate Standard Deviation to assess the effectiveness of a coun- for the product group. try’s overall compliance program and (5) The Absolute Minimum PFF Re- to determine the course of action for quirement is that no laboratory result subsequent lots of product.

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(1) Factors determining whether a origin shall be notified, and shall be country’s inspection system is func- subject to other actions pursuant to tioning adequately: the Act. (i) The PFF percentage for each sam- (c) Retention. When lots of cured pork ple must not be below the minimum product are under retention they shall PFF requirement by 2.3 percentage be refused entry and reexported in ac- points for cured pork products in cordance with § 327.13 of this sub- Groups I and II or 2.7 percentage points chapter unless they can be released in for cured pork products in Groups III accordance with the provisions of para- and IV. graph (c)(1), establishments may be re- (ii) Both of the PFF Standardized turned to normal monitoring proce- Averages, Arithmetic and Weighted, dures in accordance with paragraph for the last 100 consecutive lots of all (c)(2), and countries may be returned to cured pork products from the country normal monitoring procedures in ac- must be equal to or greater than zero. cordance with paragraph (c)(3). The count for the 100 consecutive lots (1) If a lot is subject to retention pro- starts with the lots arriving from that cedures under this section, the Depart- country after April 15, 1985. ment shall collect five randomly se- (iii) Both of the PFF Standardized lected sample units from each lot and Averages, Arithmetic and Weighted, determine the PFF of each sample for the last 36 consecutive lots of all unit. The lot may be released into com- cured pork products from the country merce if: must be above the lowest 5 percent of (i) The average PFF percentage of the Normal distribution. This mini- the five randomly selected sample mum value is minus 0.28 (¥0.28) for the units is equal to or greater than the Arithmetic Average and depends on the applicable minimum PFF percentage production volume for the Weighted required by § 319.104 or § 319.105 of this Average. subchapter, or (2) Actions when calculations indi- (ii) The product is relabeled under cate that processing procedures in a the supervision of a program employee country are out-of-compliance: so that it conforms to the provisions of (i) If the PFF level of a sample taken § 319.104 or § 319.105 of this subchapter. during normal monitoring procedures (2) If product from a foreign estab- is found to be as low as the Absolute lishment is subject to retention proce- Minimum PFF Requirement, the coun- dures under this section, the foreign es- try of origin shall be notified; the lot tablishment may be returned to nor- involved shall be retained if still avail- mal monitoring procedures when: able in an official establishment or (i) Ten consecutively presented lots subject to detention or other actions of that cured pork product from that pursuant to the Act; and all subse- establishment have been sampled as quently presented lots of that cured provided in paragraph (c)(1) of this sec- pork product from the same foreign es- tion and the average of each set of five tablishment shall be held under reten- sample units representing each lot tion until the provisions of paragraph have been found to be equal to or (c) are satisfied. greater than the required minimum (ii) If either of the PFF Standardized PFF percentage; and Averages, Arithmetic or Weighted, for (ii) The PFF percentage of each sam- the last 100 consecutive lots falls below ple unit (50 in all) is above the Abso- zero or either of the PFF Standardized lute Minimum PFF Percentage. Averages for the last 36 consecutive (3) If a country is subject to reten- lots falls below the upper 95 percent of tion procedures under this section, the the Normal distribution, all available country shall be returned to normal cured pork product from the foreign monitoring procedures when: country shall be subject to administra- (i) Twenty-five consecutively pre- tive retention and all subsequently presented lots of cured pork product have sented lots of cured pork product from been sampled as required in paragraph the foreign country shall be held under (c)(1) of this section and the average of retention until the provisions of para- each set of five sample units represent- graph (c) are satisfied. The country of ing each lot have been found to be

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equal to or greater than the required (1) The following agents are pre- minimum PFF percentage; and scribed for denaturing carcasses, parts (ii) The PFF percentage of each sam- thereof, meat or meat food products ple unit (125 in all) is above the Abso- which are affected with any condition lute Minimum PFF Percentage; and that would result in their condemna- (iii) Both of the PFF Standardized tion and disposal under part 314 of this Averages for 36 consecutive lots are in subchapter if they were at an official the required percentage of the Normal establishment or at an official import distribution; and inspection establishment: Crude car- (iv) Both of the PFF Standardized bolic acid; cresylic disinfectant; a for- Averages for 100 consecutive lots are mula consisting of 1 part FD&C green zero or higher. No. 3 coloring, 40 parts water, 40 parts (4) The sample units collected under liquid detergent, and 40 parts oil of cit- retention procedures as provided in ronella, or other proprietary substance paragraph (c)(2) of this section will not approved by the Administrator in spe- be included in the PFF standardized cific cases.1 averages for 36 and 100 consecutive (2) Meat may be denatured by dipping lots. it in a solution of 0.0625 percent tannic (d) Adulterated and Misbranded Prod- acid, followed by immersion in a water ucts. Products not meeting specified bath, then dipping it in a solution of PFF requirements, determined accord- 0.0625 percent ferric acid; and except as ing to procedures set forth in this sec- provided in paragraphs (a) (3) and (5) of tion, may be deemed adulterated under this section, the following agents are section 1(m)(8) of the Act (21 U.S.C. prescribed for denaturing other car- 601(m)(8)) and misbranded under sec- casses, parts thereof, meat and meat tion 1(n) of the Act (21 U.S.C. 601(n)). food products, for which denaturing is (e) Activities requiring additional required by this part: FD&C green No. inspectional supervision, such as re- 3 coloring; FD&C blue No. 1 coloring; labeling, shall be at the importer’s ex- FD&C blue No. 2 coloring; finely pow- pense. In addition, if the importer dered charcoal; or other proprietary wishes, he or she may have samples substance approved by the Adminis- analyzed at an accredited laboratory. trator in specific cases.1 Carcasses [50 FR 9792, Mar. 12, 1985, as amended at 54 (other than viscera), parts thereof, cuts FR 41049, Oct. 5, 1989] of meat, and unground pieces of meat darkened by charcoal or other black § 327.24 Appeals; how made. dyes shall be deemed to be denatured Any appeal from a decision of any pursuant to this section only if they program employee shall be made to his/ contain at least that degree of dark- her immediate supervisor having juris- ness depicted by diagram 1 of the Meat diction over the subject matter of the Denaturing Guide (MP Form 91).2 appeal, except as otherwise provided in (3) Tripe may be denatured by dip- the applicable rules of practice. ping it in a 6 percent solution of tannic [51 FR 37707, Oct. 24, 1986, as amended at 60 1 FR 67456, Dec. 29, 1995] Information as to approval of any proprietary denaturing substance may be obtained § 327.25 Disposition procedures for from the Meat and Poultry Inspection Tech- product condemned or ordered de- nical Services, Food Safety and Inspection stroyed under import inspection. Service, U.S. Department of Agriculture, Washington, DC 20250. (a) Carcasses, parts thereof, meat and 2 Copies of MP Form 91 may be obtained, meat food products (other than ren- without charge, by writing to the Adminis- dered animal fats) that have been trative Operations Branch, Food Safety and treated in accordance with the provi- Inspection Service, U.S. Department of Agri- sions of this section shall be considered culture, 123 East Grant Street, Minneapolis, denatured for the purposes of the regu- Minnesota 55403. Diagrams 2 and 3 of the lations in this part, except as other- Meat Denaturing Guide are for comparison purposes only. The Meat Denaturing Guide wise provided in part 314 of this sub- has been approved for incorporation by ref- chapter for articles condemned at offi- erence by the Director, Office of the Federal cial establishments or at official im- Register, and is on file at the Federal Reg- port inspection establishments. ister Library.

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acid for 1 minute followed by immer- cannot be confused with an article of sion in a water bath, then immersing it human food. for 1 minute in a solution of 0.022 per- [51 FR 37707, Oct. 24, 1986] cent FD&C yellow No. 5 coloring. (4) When meat, meat byproducts, or § 327.26 Official import inspection meat food products are in ground form, marks and devices. 4 percent by weight of coarsely ground (a) When import inspections are per- hard done, which shall be in pieces no formed in official import inspection es- smaller than the opening size specified tablishments, the official inspection for No. 5 mesh in the standards issued legend to be applied to imported meat by the U.S. Bureau of Standards or 6 and meat food products shall be in the percent by weight of coarsely ground appropriate form 1 as herein specified. hard bone, which shall be in pieces no smaller than the opening size specified for No. 8 mesh in said Standards, uniformly incorporated with the product, may be used in lieu of the agents prescribed in paragraph (a)(2) of this section. (5) Before the denaturing agents are applied to articles in pieces more than 4 inches in diameter, the pieces shall be freely slashed or sectioned. (If the articles are in pieces not more than 4 inches in diameter, slashing or sectioning will not be necessary.) The application of any of the denaturing agents For application to cattle, sheep, listed in paragraph (a) (1) or (2) of this swine, and goat carcasses, primal section to the outer surface of molds or parts, and cuts, not in containers. blocks or boneless meat, meat by-products, or meat food products shall not be adequate. The denaturing agent must be mixed intimately with all the material to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food. (b) Inedible rendered animal fats shall be denatured by thoroughly mixing therein denaturing oil, No. 2 fuel oil, brucine dissolved in a mixture of alcohol and pine oil or oil of rosemary, finely powdered charcoal, or any proprietary denaturing agent approved for For application to outside containers the purpose by the Administrator in of meat and meat food products pre- specific cases. The charcoal shall be pared from cattle, sheep, swine, and used in no less quantity than 100 parts goats. per million and shall be of such character that it will remain suspended in- 1 The number ‘‘I–38’’ is given as an example definitely in the liquid fat. Sufficient only. The establishment number of the offi- of the chosen identifying agents shall cial import inspecton establishment where be used to give the rendered fat so dis- the imported product is inspected shall be tinctive a color, odor, or taste that it used in lieu thereof.

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For application to outside containers For application to horse carcasses, of equine meat food products. (b) Except for product offered for primal parts, and cuts, not in contain- entry from Canada, when import in- ers. spections are performed in official establishments the official inspection legend to be applied to meat and meat food products offered for entry shall be the appropriate form as specified in §§ 312.2 and 312.3 of this subchapter. (c) When products are refused entry into the United States, the official mark to be applied to the products refused entry shall be in the following form:

For application to outside containers of horsemeat food products. (d) Devices for applying ‘‘United States Refused Entry’’ marks shall be furnished to Program inspectors by the Department. (e) The ordering and manufacture of brands containing official inspection legends shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations. [51 FR 37708, Oct. 24, 1986, as amended at 54 FR 41049, Oct. 5, 1989]

PART 329—DETENTION; SEIZURE AND CONDEMNATION; CRIMI- NAL OFFENSES For application to mule and other (nonhorse) equine carcasses, primal Sec. 329.1 Article or livestock subject to admin- parts, and cuts, not in containers. istrative detention.

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329.2 Method of detention; form of detention tained’’ tag (FSIS Form 8400–2) to such tag. article or livestock. 329.3 Notification of detention to the owner of the article or livestock detained, or [55 FR 47842, Nov. 16, 1990] the owner’s agent, and person having custody. § 329.3 Notification of detention to the 329.4 Notification of governmental authori- owner of the article or livestock de- ties having jurisdiction over article or tained, or the owner’s agent, and livestock detained; form of written noti- person having custody. fication. (a) When any article or livestock is 329.5 Movement of article or livestock de- detained under this part, an authorized tained; removal of official marks. representative of the Secretary shall: 329.6 Articles or livestock subject to judi- (1) Orally notify the immediate cus- cial seizure and condemnation. todian of the article or livestock de- 329.7 Procedure for seizure, condemnation and disposition. tained, and 329.8 Authority for condemnation or seizure (2) Promptly furnish a copy of a com- under other provisions of law. pleted ‘‘Notice of Detention’’ (FSIS 329.9 Criminal offenses. Form 8080–1) to the immediate custodian of the detained article or live- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, stock. 2.55. (b) If the owner of the detained arti- SOURCE: 35 FR 15617, Oct. 3, 1970, unless cle or livestock, or the owner’s agent, otherwise noted. is not the immediate custodian at the time of detention and if the owner, or § 329.1 Article or livestock subject to owner’s agent, can be ascertained and administrative detention. notified, an authorized representative Any carcass, part of a carcass, meat of the Secretary shall furnish a copy of or meat food product of livestock, or the completed ‘‘Notice of Detention’’ article exempted from the definition of to the owner or the owner’s agent. meat food product, or any dead, dying, Such copy shall be served, as soon as disabled, or diseased livestock is sub- possible, by delivering the notification ject to detention for a period not to ex- to the owner, or the owner’s agent, or ceed 20 days when found by any author- by certifying and mailing the notifica- ized representative of the Secretary tion to the owner, or the owner’s agent, upon any premises where it is held for at his or her last known residence or the purposes of, or during or after dis- principal office or place of business. tribution in, commerce or it is otherwise subject to Title I or II of the Act, [55 FR 47842, Nov. 16, 1990] and there is reason to believe that: § 329.4 Notification of governmental (a) Any such article is adulterated or authorities having jurisdiction over misbranded and is capable of use as article or livestock detained; form human food; or of written notification. (b) Any such article has not been in- Within 48 hours after the detention of spected, in violation of the provisions any livestock or article pursuant to of Title I of the Act, any other Federal this part, an authorized representative law, or the laws of any State or Terri- of the Secretary shall give oral or writ- tory, or the District of Columbia; or ten notification of such detention to (c) Any such article or livestock has any Federal authorities not connected been or is intended to be, distributed in with the Program, and any State or violation of the provisions of Title I of other governmental authorities, having the Act, any other Federal law, or the jurisdiction over such livestock or arti- laws of any State or Territory, or the cle. In the event notification is given District of Columbia. orally, it shall be confirmed in writing, as promptly as circumstances permit. § 329.2 Method of detention; form of detention tag. § 329.5 Movement of article or live- An authorized representative of the stock detained; removal of official Secretary shall detain any article or marks. livestock to be detained under this (a) No article or livestock detained in part, by affixing an official ‘‘U.S. De- accordance with the provisions in this

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part shall be moved by any person from or offered or received for distribution the place at which it is located when so in violation of the Act, or detained, until released by an author- (b) Is capable of use as human food ized representative of the Secretary: and is adulterated or misbranded, or Provided, That any such article or live- (c) In any other way is in violation of stock may be moved from the place at the Act. which it is located when so detained, for refrigeration, freezing, or storage § 329.7 Procedure for seizure, con- purposes if such movement has been demnation, and disposition. approved by an authorized representa- Any article or livestock subject to tive of the Secretary: And provided fur- seizure and condemnation under this ther, That the article or livestock so part shall be liable to be proceeded moved will be detained by an author- against and seized and condemned, and ized representative of the Secretary after such movement until such time disposed of, at any time, on an appro- as the detention is terminated. priate pleading in any United States (b) Upon terminating the detention district court, or other proper court of such article or livestock, an author- specified in section 404 of the Act, ized representative of the Secretary within the jurisdiction of which the ar- shall: ticle or livestock is found. (1) Orally notify the immediate custodian of the released article or live- § 329.8 Authority for condemnation or stock, and seizure under other provisions of law. (2) Furnish copies of a completed ‘‘Notice of Termination of Detention’’ The provisions of this part relating (FSIS Form 8400–1) to the persons noti- to seizure, condemnation and disposi- fied when the article or livestock was tion of articles or livestock do not der- detained. The notice shall be served by ogate from authority for condemnation either delivering the notice to such or seizure conferred by other provisions persons or by certifying and mailing of the Act, or other laws. the notice to such persons at their last known residences or principal offices § 329.9 Criminal offenses. or places of business. The Act contains criminal provisions (c) All official marks may be required with respect to numerous offenses spec- by such representative to be removed ified in the Act, including but not lim- from such article or livestock before it ited to bribery of Program employees, is released unless it appears to the sat- receipt of gifts by Program employees, isfaction of the representative that the and forcible assaults on, or other inter- article or livestock is eligible to retain ference with, Program employees while such marks. engaged in, or on account of, the per- [35 FR 15617, Oct. 3, 1970, as amended at 36 FR formance of their official duties under 12004, June 24, 1971; 39 FR 36000, Oct. 7, 1974; the Act. 55 FR 47842, Nov. 16, 1990]

§ 329.6 Articles or livestock subject to PART 331—SPECIAL PROVISIONS judicial seizure and condemnation. FOR DESIGNATED STATES AND Any carcass, part of a carcass, meat TERRITORIES; AND FOR DESIGNA- or meat food product, or any dead, TION OF ESTABLISHMENTS WHICH dying, disabled, or diseased livestock, ENDANGER PUBLIC HEALTH AND that is being transported in commerce FOR SUCH DESIGNATED ESTAB- or is otherwise subject to Title I or II LISHMENTS of the Act, or is held for sale in the United States after such transpor- Sec. tation, is subject to seizure and con- 331.1 Definition of ‘‘State.’’ demnation, in a judicial proceeding 331.2 Designation of States under paragraph pursuant to section 403 of the Act if 301(c) of the Act. such article or livestock: 331.3 States designated under paragraph (a) Is or has been prepared, sold, 301(c) of the Act; application of regula- transported, or otherwise distributed tions.

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331.4 Control and disposal of non-federally- Sections Affected in the Finding Aids sec- inspected products in States designated tion of this volume. under paragraph 301(c) of the Act. 331.5 Criteria and procedure for designating § 331.3 States designated under para- establishments with operations which graph 301(c) of the Act; application would clearly endanger the public health; of regulations. disposition of products; application of regulations. The provisions of the regulations in 331.6 Designation of States under section this subchapter apply to operations 205 of the Act; application of sections of and transactions wholly within each the Act and the regulations. State designated in § 331.2 under para- AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, graph 301(c) of the Act, except as other- 2.55. wise provided in this section. (The pro- SOURCE: 35 FR 19667, Dec. 29, 1970, unless visions of the regulations apply in all otherwise noted. respects to operations and transactions in or for commerce.) § 331.1 Definition of ‘‘State’’. (a) Each establishment, located in For purposes of this part, the term such a designated State, which is ‘‘State’’ means any State (including granted inspection required under the Commonwealth of Puerto Rico) or § 302.1(a)(2) of this subchapter, shall ob- organized Territory. tain approval of plant drawings as specified in § 304.2 of this subchapter § 331.2 Designation of States under within 18 months after the designation paragraph 301(c) of the Act. of the State becomes effective. The es- Each of the following States has been tablishment, including its facilities designated, under paragraph 301(c) of shall be placed in compliance with the the Act, as a State in which the provi- approved drawings as soon as possible, sions of Titles I and IV of the Act shall but not to exceed 36 months after such apply to operations and transactions designation becomes effective. Failure wholly within such State. The Federal to have drawings approved or to bring provisions apply, effective on the dates the establishment into compliance shown below: with such drawings within the time periods specified herein will result in the Effective date of applica- State tion of Federal provisions expiration of the grant of inspection. Inspection will be initially granted to Arkansas ...... June 1, 1981. any such establishments only if it is California ...... Apr. 1, 1976. Colorado ...... July 1, 1975. found, upon a combined evaluation of Connecticut ...... Oct. 1, 1975. its premises, facilities and operating Guam ...... Jan. 21, 1972. procedures, to be capable of producing Hawaii ...... Nov. 1, 1995. Idaho ...... July 1, 1981. products that are not adulterated or Kentucky ...... Jan. 14, 1972. misbranded. Maine ...... May 12, 1980. (b) Section 305.2 of this subchapter Maryland ...... March 31, 1991 Massachusetts ...... Jan. 12, 1976. will apply to establishments required Michigan ...... Oct. 3, 1981. to have inspection under § 302.1(a)(2) of Minnesota ...... May 16, 1972. this subchapter, except that existing Missouri ...... Aug. 18, 1972. Nebraska ...... Oct. 1, 1971. interconnections between official and Nevada ...... July 1, 1973. unofficial establishments will be per- New Hampshire ...... Aug. 6, 1978. mitted if it is determined in specific New Jersey ...... July 1, 1975. New York ...... July 16, 1975. cases that the interconnections are North Dakota ...... June 22, 1970. such that transfer of inedible product Northern Mariana Islands ...... Oct. 29, 1979. into the official establishment would Oregon ...... July 1, 1972. be difficult or unusual, and any such Pennsylvania ...... July 17, 1972. Puerto Rico ...... June 18, 1971. transfers are strictly prohibited, except Rhode Island ...... Oct. 1, 1981. as permitted under other provisions of Tennessee ...... Oct. 1, 1975. this subchapter. It is essential that Virgin Islands of the U.S ...... Nov. 27, 1971. Washington ...... June 1, 1973. separation of facilities be maintained to the extent necessary to assure that [35 FR 19667, Dec. 29, 1970] inedible product does not enter the of- EDITORIAL NOTE: For FEDERAL REGISTER ci- ficial establishment contrary to the tations affecting § 331.2, see the List of CFR regulations in this subchapter.

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(c) Section 308.4 of this subchapter features required by paragraph 1(n) of shall apply to such establishments, ex- the Act. cept that separate facilities for men (2) The circuit supervisor will for- and women workers will not be re- ward one copy of each item of labeling quired when the majority of the work- and a description of each marking de- ers in the establishment are related by vice for which he has granted tem- blood or marriage, provided that this porary approval to the Washington, will not conflict with municipal or DC, office of the Labeling and Packag- State requirements: and except that ing Staff and will retain one copy in a separation of toilet soil lines from temporary approval file for the estab- house drainage lines to a point outside lishment. the buildings will not be required in ex- (3) The operator of the official estab- isting construction when positive act- lishment shall promptly forward a copy ing back-flow devices are installed. of each item of labeling and a descrip- (d) Section 314.2 of this subchapter tion of each marking device for which shall apply to such establishments, ex- temporary approval has been granted cept that a separate room or compart- by the circuit supervisor (showing any ment need not be provided for inedible modifications required by the circuit products if they can be handled so that supervisor) to the Labels and Packag- they do not create insanitary condi- ing Staff, Meat and Poultry Inspection, tions in any room or compartment Food Safety and Inspection Service, used for edible products or otherwise USDA, Washington, DC 20250, accom- render any edible products adulterated panied by the formula and details of and do not interfere with the conduct preparation and packaging for each of inspection. For example, intestines, product. Within 90 days after inaugura- paunch contents, feet, and hides might tion of inspection, all labeling material be accumulated on the kill floor in and marking devices temporarily ap- clean, watertight drums with close fit- proved by the circuit supervisor must ting covers if there is sufficient space receive approval as required by §§ 316.7, to store them out of the way until the 317.3, and 317.4, of this subchapter or close of the day’s operation. their use must be discontinued. (e) Sections 316.7, 317.3, and 317.4 of this subchapter shall apply to such es- (4) The circuit supervisor will also re- tablishments, except as provided in view all shipping containers to insure this paragraph (e). that they do not have any false or mis- (1) The operator of each such estab- leading labeling and are otherwise not lishment shall, prior to the inaugura- misbranded. Modifications of unaccept- tion of inspection, identify all labeling able information on labeling material and marking devices in use, or pro- by the use of self-destructive pressure posed for use (upon the date of inau- sensitive tape or by blocking out with guration of inspection) to the circuit an ink stamp will be authorized on a supervisor of the circuit in which the temporary basis to permit the maxi- establishment is located. Temporary mum allowable use of all labeling ma- approval, pending formal approval terials on hand. All unacceptable label- under §§ 316.7, 317.3, and 317.4 of this ing material which is not modified to subchapter, will be granted by the cir- comply with the requirements of this cuit supervisor for labeling and mark- subchapter must be destroyed or re- ing devices that he determines are nei- moved from the official establishment. ther false nor misleading, provided the (f) Sections 320.1, 320.2, 320.3, 320.4, official inspection legend bearing the 320.5, 325.20, and 325.21 apply to oper- official establishment number is ap- ations and transactions not in or for plied to the principal display panel of commerce in a State designated under each label, either by a mechanical paragraph 301(c) only if the State is printing device or a self-destructive also designated under section 205 of the pressure sensitive sticker, and provided Act and if such provisions are applica- the label shows the true product name, ble as shown in § 331.6. an accurate ingredient statement, the (g) Section 321.1(a) of this subchapter name and address of the manufacturer, will not apply to States designated packer, or distributor, and any other under paragraph 301(c) of the Act.

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(h) Parts 322 and 327 and § 325.3 of this dled in accordance with § 305.4 of this subchapter relating to exports and im- subchapter. Such products shall not ports do not apply to operations and bear any [Federal] official inspection transactions solely in or for intrastate legends. After said 90–day period, only commerce. federally inspected and passed products (i) Part 325 of this subchapter will may be distributed within the des- apply to establishments required to ignated State, except as provided in have inspection under § 302.1(a)(2) of § 303.1 of this subchapter. this subchapter and to operations and transactions solely in or for intrastate § 331.5 Criteria and procedure for des- commerce, except as provided in para- ignating establishments with oper- graphs (h) and (j) of this section. ations which would clearly endan- (j) Sections 325.4, 325.15, and 325.1(b) ger the public health; disposition of products; application of regula- of this subchapter will not apply to re- tions. quire a certificate, or evidence thereof, for the distribution solely within any (a) An establishment preparing prod- designated State of products that are ucts solely for distribution within any U.S. inspected and passed and so State shall be designated as one pro- marked. ducing adulterated products which would clearly endanger the public [35 FR 19667, Dec. 29, 1970, as amended at 36 health, if: FR 12004, June 24, 1971; 41 FR 18089, Apr. 30, (1) Any meat or meat food product 1976] prepared at the establishment is adul- § 331.4 Control and disposal of non- terated in any of the following re- federally-inspected products in spects: States designated under paragraph (i) It bears or contains a pesticide 301(c) of the Act. chemical, food additive, or color addi- Upon the effective date of designa- tive, that is ‘‘unsafe’’ within the mean- tion of a State under paragraph 301(c) ing of sections 408, 409, or 706 of the of the Act, no products can be prepared Federal Food, Drug, and Cosmetic Act within the State unless they are pre- or was intentionally subjected to radi- pared under inspection pursuant to the ation in a manner not permitted under regulations in this subchapter or are section 409 of said Act; or if it bears or exempted from the requirement of in- contains any other added poisonous or spection under § 303.1 of this sub- added deleterious substance which may chapter, and no unexempted products render it injurious to health or make it which were prepared without any in- unfit for human food; or spection can lawfully be distributed (ii) It consists in whole or in part of within the State. For a period of 90 any filthy, putrid, or decomposed sub- days from the effective date of such stance or is for any other reason un- designation, products which were pre- sound, unhealthful, or unwholesome or pared and inspected and passed under otherwise unfit for human food (for ex- the supervision of a responsible State ample, it was prepared from meat or or local inspection agency can be dis- other ingredients exhibiting spoilage tributed solely within the State, pro- characteristics; or it is, or was pre- vided they are not adulterated or mis- pared from, a carcass affected with a branded, except that the official in- disease transmissible to humans and spection legend is not required. Within its condemnation would be required the 90-day period, products that have under part 309 or 310 of the Federal been inspected by the State or local in- Meat Inspection regulations (9 CFR spection agency may be further pre- parts 309, 310) at federally inspected es- pared and otherwise handled in official tablishments; or it is a ready-to-eat establishments required to have inspec- pork product which has not been treat- tion under § 302.1(a)(2) of this sub- ed to destroy trichinae as prescribed in chapter or at establishments exempted § 318.10 of this subchapter for products from the requirements of such inspec- at federally inspected establishments); tion under § 303.1 of this subchapter, or and may be distributed as provided in (iii) It has been prepared, packed or this section but otherwise shall be han- held under insanitary conditions

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whereby it may have become contami- essary corrections, and notifying him nated with filth or may have been ren- that failure to correct such deficiencies dered injurious to health (for example may result in designation of the estab- if insects or vermin are not effectively lishment and operator thereof as sub- controlled at the establishments, or in- ject to the provisions of titles I and IV sanitary water is used in preparing of the Act as though engaged in com- meat or meat food products for human merce. food); or (3) Thereafter the Program Inspector (iv) It is, in whole or in part, the shall survey the establishment and des- product of an animal that died other- ignate it if he determines, in consulta- wise than by slaughter; or tion with the Regional Director, that it (v) Its container is composed, in is producing adulterated products, whole or in part, of any poisonous or deleterious substance which may which would clearly endanger the pub- render the contents injurious to lic health, and formal notice of such health; and designation will be issued to the opera- (2) Such adulterated articles are in- tor of the establishment by the Re- tended to be or are distributed from gional Director. the establishment while capable of use (c) Products on hand at the time of as human food. designation of an establishment under (b) When any such establishment is this section are subject to detention, identified by a Program Inspector as seizure and condemnation in accord- one producing adulterated product, ance with part 329 of this subchapter: which would clearly endanger public Provided, That products that have been health under the criteria in paragraph federally inspected and so identified (a) of this section, the following proce- and that have not been further pre- dure will be followed: pared at any nonfederally inspected es- (1) The Program Inspector will infor- tablishment may be released for dis- mally advise the operator of the estab- tribution if the products appear to be lishment concerning the deficiencies not adulterated or misbranded at the found by him and report his findings to time of such release. the appropriate Regional Director for (d) No establishment designated the Program. When it is determined by under this section can lawfully prepare the Regional Director that any estab- any products unless it first obtains in- lishment preparing products solely for distribution within any State is pro- spection or qualifies for exemption ducing adulterated products for dis- under § 303.1 of this subchapter. All of tribution within such State which the provisions of the regulations shall would clearly endanger the public apply to establishments designated health, written notification thereof under this section, except that the ex- will be issued to the appropriate State ceptions provided for in § 331.3 of this officials, including the Governor of the part shall apply to such establish- State and the appropriate Advisory ments. Committee, for effective action under State or local law to prevent such en- § 331.6 Designation of States under dangering of the public health. Such section 205 of the Act; application written notification shall clearly speci- of sections of the Act and the regu- fy the deficiencies deemed to result in lations. the production of adulterated products Each of the following States has been and shall specify a reasonable time for designated, effective on the date shown such action under State or local law. below, under section 205 of the Act, as (2) If effective action is not taken a State in which the provisions of the under State or local law within the sections of the Act and regulations specified time, written notification specified below shall apply to operators shall be issued by the Regional Direc- engaged, other than in or for com- tor to the operator of the establish- merce, in the kinds of business indi- ment, specifying the deficiencies in- cated below: volved and allowing him ten days to present his views or make the nec-

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Sections of act and regu- Effective date of lations Classes of operators State designation

Act, section 202; §§ Persons engaged (not in or for commerce) in (1) the busi- Arkansas ...... Mar. 29, 1982. 320.1, 320.2, 320.3, ness of slaughtering any livestock or preparing, freezing, California ...... Apr. 1, 1976. and 320.4. packaging or labeling any livestock carcasses or parts or Colorado ...... July 1, 1975. products thereof, for use as human food or animal food; Connecticut ...... Oct. 1, 1975. (2) the business of buying or selling (as a meat broker, Guam ...... Nov. 19, 1976. wholesaler, or otherwise), transporting or storing any live- Idaho ...... Mar. 29, 1982. stock carcasses or parts or products thereof; or (3) busi- Kentucky ...... Apr. 18, 1973. ness as a renderer, or in the business of buying, selling, or Maine ...... Feb. 9, 1981. transporting any dead, dying, disabled, or diseased live- Maryland ...... Mar. 31, 1991. stock or parts of carcasses of any livestock that died other- Massachusetts .. Jan. 12, 1976. wise than by slaughter. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975. North Dakota .... July 23, 1973. Northern Mari- Oct. 29, 1979. ana Islands. Oregon ...... Jan. 31, 1975. Pennsylvania .... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 203; § 320.5 ...... Persons engaged (not in or for commerce) in business as a Arkansas ...... Mar. 29, 1982. meat broker; renderer; animal food manufacturer; whole- California ...... Apr. 1, 1976. saler or public warehouseman of livestock carcasses, or Colorado ...... July 1, 1975. parts or products thereof; or buying, selling, or transporting Connecticut ...... Oct. 1, 1973. any dead, dying, disabled, or diseased livestock, or parts Guam ...... Nov. 19, 1976. of carcasses of any such livestock that dies otherwise than Idaho ...... Mar. 29, 1982. by slaughter. Kentucky ...... Apr. 18, 1976. Maine ...... Feb. 9, 1981. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1975. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1973. North Dakota .... July 23, 1975. Northern Mari- Oct. 29, 1979. ana Islands. Oregon ...... Jan. 31, 1974. Pennsylvania .... May 2, 1975. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Tennessee ...... Oct. 1, 1975. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Act, 204; §§ 325.20 and Persons engaged (not in or for commerce) in the business of Arkansas ...... Mar. 29, 1982. 325.21. buying, selling or transporting any dead, dying, disabled or Connecticut ...... Oct. 1, 1975. diseased animals, or parts of carcasses of any animals Guam ...... Nov. 19, 1976. that died otherwise than by slaughter. Idaho ...... Mar. 29, 1982. Kentucky ...... Apr. 18, 1973. Maine ...... Feb. 9, 1981. Maryland ...... Mar. 31, 1991. Massachusetts .. Jan. 12, 1976. Michigan ...... Mar. 29, 1982. Minnesota ...... Jan. 31, 1975. Nevada ...... Jan. 31, 1975. New Hampshire Oct. 29, 1979. New Jersey ...... July 1, 1975. New York ...... July 16, 1975. North Dakota .... July 23, 1973. Northern Mari- Oct. 29, 1979. ana Islands.

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Sections of act and regu- Effective date of lations Classes of operators State designation

Oregon ...... Jan. 31, 1975. Pennsylvania .... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island .... Mar. 29, 1982. Virgin Islands .... Nov. 19, 1976. Washington ...... Jan. 31, 1975.

[35 FR 19667, Dec. 29, 1970]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 331.6, see the List of CFR Sec- tions Affected in the Finding Aids section of this volume.

PART 335—RULES OF PRACTICE 335.32 Procedure upon receipt of the estab- GOVERNING PROCEEDINGS lishment answer. UNDER THE FEDERAL MEAT IN- Subpart E—Criminal Violations SPECTION ACT 335.40 Opportunity for presentation of views before report of criminal violations. Subpart A—General AUTHORITY: 21 U.S.C. 601–695; 7 CFR 2.17, Sec. 2.55. 335.1 Scope and applicability of rules of SOURCE: 42 FR 10960, Feb. 25, 1977, unless practice. otherwise noted. Subpart B—Supplemental Rules of Practice Subpart A—General 335.10 Refusal or withdrawal of inspection service under section 401 of the Act. § 335.1 Scope and applicability of rules 335.11 Withdrawal of inspection service for of practice. failure of an establishment to destroy (a) The Uniform Rules of Practice for any condemned carcass or part thereof or any condemned meat or meat food prod- the Department of Agriculture promul- uct. gated in subpart H of part 1, subtitle A, 335.12 Withholding use of marking, labeling, title 7, Code of Federal Regulations, or containers from use under section 7 of are the Rules of Practice applicable to the Federal Meat Inspection Act. adjudicatory, administrative proceed- 335.13 Refusal or withdrawal of inspection ings under sections 4, 6, 7(e), 8, and 401 service under the Federal Meat Inspec- of the Federal Meat Inspection Act (21 tion Act for failure to maintain sanitary U.S.C. 604, 606, 607(e), 608 and 671). In conditions. addition, the Supplemental Rules of Practice set forth in subpart B of this Subpart C—Rules Applicable to Suspen- part shall be applicable to such pro- sion of Assignment of Inspectors for ceedings. Threats to Forcibly Assault or Forcible (b) The rules of practice set forth in Assault, Intimidation or Interference subpart C of this part shall be applica- With Any Inspection Service Employee ble to the suspension of assignment of 335.20 Notification to operator of establish- inspectors for threats to forcibly as- ment of incident. sault or forcible assault, intimidation 335.21 Procedure upon failure of operator of or interference with any inspection establishment to take action required by service employee pursuant to § 305.5(b) § 305.5(b) of the regulations. of the regulations (9 CFR 305.5(b)) under the Federal Meat Inspection Act. Subpart D—Rules Applicable to Suspension In addition, the definitions applicable of Assignment of Inspectors Under to proceedings under the Uniform Section 3(b) of the Federal Meat In- Rules of Practice (7 CFR 1.132) shall spection Act apply with equal force and effect to 335.30 Suspension of the assignment of in- proceedings under subpart C. spectors under section 3(b) of the Act. (c) The rules of practice set forth in 335.31 Written notification to operator of subpart D of this part shall be applica- establishment of incident. ble to the suspension of assignment of

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inspectors under section 3(b) of the Act tablishment. In the event of oral notifi- (21 U.S.C. 603(b)). In addition, the defi- cation, a written confirmation shall be nitions applicable to proceedings under given, as promptly as circumstances the Uniform Rules of Practice (7 CFR permit, to the operator of the estab- 1.132) shall apply with equal force and lishment of the intent to withdraw in- effect to proceedings under part 313. spection. The written notification or [42 FR 10960, Feb. 25, 1977, as amended at 44 confirmation shall be served upon the FR 68817, Nov. 30, 1979] operator of the establishment in the manner prescribed in § 1.147(b) of the Subpart B—Supplemental Rules of Uniform Rules of Practice (7 CFR 1.147(b)). Practice (b) If any establishment so notified § 335.10 Refusal or withdrawal of in- fails to destroy any condemned carcass spection service under section 401 or part thereof or any condemned meat of the Act. or meat food product as specified in the If the Administrator has reason to notice, the Administrator may issue believe that the applicant for or recipi- and file a complaint in accordance with ent of service under Title I of the Act the Uniform Rules of Practice. Effec- is unfit to engage in any business re- tive upon service of the complaint, in- quiring such inspection because of any spection service under the Act shall be of the reasons specified in section 401 of withdrawn from such establishment as the Act, he may institute a proceeding provided in sections 4, 6, and 401 of the by filing a complaint with the Hearing Federal Meat Inspection Act (21 U.S.C. Clerk, who shall promptly serve a true 604, 606 and 671), pending final deter- copy thereof upon each respondent, as mination in the proceeding. provided in § 1.147(b) of the Uniform Rules of Practice (9 CFR 1.147(b)). § 335.12 Withholding use of marking, labeling, or containers from use under section 7 of the Federal Meat § 335.11 Withdrawal of inspection serv- Inspection Act. ice for failure of an establishment to destroy any condemned carcass (a) In any situation in which the Ad- or part thereof or any condemned ministrator determines that any mark- meat or meat food product. ing or labeling or size or form of any (a) In any situation in which the Ad- container in use or proposed for use ministrator has reason to believe that with respect to any article subject to an establishment which receives in- Title I of the Federal Meat Inspection spection service under Title I of the Act is false or misleading in any par- Federal Meat Inspection Act has failed ticular, he shall notify, in writing, the to destroy any condemned carcass or person, firm, or corporation using or part thereof or any condemned meat or proposing to use such marking, label- meat food product, as required under ing, or container that such use shall be sections 4 and 6 of the Federal Meat In- withheld unless the marking, labeling, spection Act (21 U.S.C. 604 and 606) and or container is modified in such a man- the regulations in this subchapter, he ner as the Administrator may prescribe may notify the operator of the estab- so that it would not be false or mis- lishment, orally or in writing, of the leading. Administrator’s intent to withdraw (b) The written notification shall (for such period or indefinitely as the briefly set forth the reason for with- Administrator deems necessary to ef- holding the use of the marking, label- fectuate the purposes of the Act) in- ing, or container, and shall offer the re- spection service from the establish- spondent an opportunity to submit a ment, pursuant to sections 4, 6, and 401 written statement by way of answer to of the Act (21 U.S.C. 604, 606, and 671) the notification and a right to request and § 305.5(a) of the regulations (9 CFR a hearing with respect to the merits or 305.5(a)), if the establishment fails to validity of the withholding action. The destroy the condemned articles in- written notification shall be served in volved, as specified in the notification, the manner prescribed in § 1.147(b) of within three days of the receipt of the the Uniform Rules of Practice (7 CFR notification by the operator of the es- 1.147(b)).

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(c) Effective upon service of the noti- complaint, inspection service shall be fication, the use of the marking, label- refused or withdrawn from such estab- ing, or container shall be withheld, if lishment as provided in sections 8 and the Administrator so directs. 401 of the Act pending final determina- (d) If any person, firm, or corporation tion in the proceeding. so notified fails to accept the determination of the Administrator and Subpart C—Rules Applicable to files an answer and requests a hearing, Suspension of Assignment of and the Administrator, after review of Inspectors for Threats to Forc- the answer, determines the initial de- ibly Assault or Forcible As- termination to be correct, he shall file with the Hearing Clerk the notifica- sault, Intimidation or Inter- tion, answer and request for hearing, ference With Any Inspection which shall constitute the complaint Service Employee and answer in the proceeding, which § 335.20 Notification to operator of es- shall thereafter be governed by the tablishment of incident. Uniform Rules of Practice. In any situation in which a super- § 335.13 Refusal or withdrawal of in- visor of an inspection service employee spection service under the Federal determines that the operator of any of- Meat Inspection Act for failure to ficial establishment or any subsidiary maintain sanitary conditions. therein, or any officer, employee, or (a) In any situation in which the Ad- agent of any such operator or any sub- ministrator determines that the sani- sidiary therein, acting within the scope tary conditions of an establishment of his office, employment, or agency, which is applying for inspection or re- has threatened to forcibly assault or ceiving inspection under Title I of the has forcibly assaulted, intimidated or Federal Meat Inspection Act are such interfered with any inspection service that any meat or meat food product employee, under his supervision, in or prepared therein are or would be ren- on account of the performance of the dered adulterated, he shall refuse to employee’s official duties under the allow said meat or meat food products Act, he shall notify the operator of the to be labeled, marked, stamped, or establishment, orally or in writing, of tagged as ‘‘inspected and passed,’’ pur- the incident in accordance with suant to section 8 of the Act (21 U.S.C. § 305.5(b) of the regulations in this subchapter (9 CFR 305.5(b)). 608). The Administrator shall notify the applicant or operator of the estab- § 335.21 Procedure upon failure of op- lishment, orally or in writing, as erator of establishment to take ac- promptly as circumstances permit, of tion required by § 305.5(b) of the such refusal to inspect and pass the regulations. meat or meat food products and the (a) If any operator of an establish- reasons therefor, and the action which ment notified pursuant to § 335.20 fails the Administrator deems necessary to to promply take any of the actions eliminate the insanitary conditions. In specified in § 305.5(b) of the regulations the event of oral notification, written (9 CFR 305.5(b)), the Administrator confirmation shall be given, as prompt- may suspend the assignment of inspec- ly as circumstances permit, to the ap- tors at that establishment, in whole or plicant or operator of the establish- in part, as the Administrator deter- ment in the manner prescribed in mines necessary to avoid impairment § 1.147(b) of the Uniform Rules of Prac- of the effective conduct of inspection tice (7 CFR 1.147(b)). service, by notifying the operator of (b) If any applicant or operator of an the establishment, orally or in writing, establishment so notified fails to take of such suspension. In the event of oral the necessary action to eliminate the notification, a written confirmation insanitary conditions within the period shall be given, as promptly as cir- specified in the notice, the Adminis- cumstances permit, to the operator of trator may issue a complaint in ac- the establishment. The written notifi- cordance with the Uniform Rules of cation or confirmation shall be served Practice. Effective upon service of the upon the operator of the establishment

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in the manner prescribed in § 1.147(b) of have been inhumanely slaughtered or the Uniform Rules of Practice (7 CFR handled in connection with slaughter 1.147(b)). at an official establishment, the Ad- (b) The written notification or con- ministrator may suspend the assign- firmation, specified in paragraph (a) of ment of inspectors at that establish- this section, which shall constitute the ment, in whole or in part, as the Ad- complaint in the proceeding, shall ministrator determines necessary to briefly set forth the reason for the sus- prevent inhumane treatment of live- pension of the assignment of inspec- stock. The Administrator shall notify tors, including allegations of fact the operator of an establishment orally which constitute a basis for the action. or in writing, of such suspension as The complaint shall offer the respond- soon as possible. In the event of oral ent opportunity to submit a specific notification, a written confirmation written statement by way of answer shall be given as promptly as cir- and the right to request a hearing with cumstances permit to the operator of respect to the merits or validity of the the establishment. The written notifi- suspension action, and shall state the cation or confirmation shall be served time within which answer by the re- upon the operator of the establishment spondent must be made, which shall in a manner prescribed in § 1.147(b) of not be less than 10 days after service of the Uniform Rules of Practice (7 CFR the complaint. At any time prior to the 1.147(b)). close of the hearing, the complaint may be amended; but, in case of an § 335.31 Written notification to opera- amendment adding new provisions, the tor of establishment of incident. hearing shall, on the request of the re- The written notification or confirma- spondent, be adjourned for a period not tion, specified in § 335.30, shall con- exceeding 15 days, if the judge deter- stitute the complaint in the proceeding mines that such and adjournment is and shall briefly set forth the reason necessary to avoid prejudice to the re- for the suspension of the assignment of spondent. inspectors, including allegations of (c) A copy of the complaint served fact which constitute a basis for the upon the respondent shall be filed with action. The complaint shall offer the the Hearing Clerk who shall assign the establishment the opportunity to re- matter a docket number. quest a hearing with respect to the (d) After the complaint is served merits or validity of the suspension ac- upon the respondent, as provided in tion and shall give the establishment paragraphs (a) and (b) of this section, the opportunity to furnish written as- the proceeding shall thereafter be con- surances satisfactory to the Secretary ducted in accordance with rules of that all inhumane slaughtering and practice which shall be adopted for the handling in connection with slaughter proceeding. have stopped and will not recur. The complaint shall state the time within Subpart D—Rules Applicable to which the respondent’s answer must be Suspension of Assignment of made, which shall not be less than 10 Inspectors Under Section 3(b) days after service of the complaint. of the Federal Meat Inspec- § 335.32 Procedure upon receipt of the tion Act establishment answer. If any establishment notified in ac- AUTHORITY: Sec. 21, 34 Stat. 1260, as amended, 21 U.S.C. 621; 92 Stat. 1069, 42 FR 35625, cordance with § 335.31: 35626, 35631. (a) Returns an answer and requests a SOURCE: 44 FR 68817, Nov. 30, 1979, unless hearing, the complaint, answer, and re- otherwise noted. quest for hearing shall be filed with the Hearing Clerk, who shall assign the § 335.30 Suspension of the assignment matter a docket number. The proceed- of inspectors under section 3(b) of ing shall thereafter be conducted in ac- the Act. cordance with the rules of practice In any situation in which the Admin- which shall be adopted for the proceed- istrator has determined that livestock ing; or

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(b) Returns written assurances which (1) Notice and opportunity need not the Secretary determines to be unsatis- be provided if the Secretary has any factory, the establishment shall reason to believe that providing such promptly be informed of this deter- notice and opportunity could result in mination in a written notification. the alteration or destruction of evi- Said notification shall briefly set forth dence, or where disclosure could result the reason the assurances were deemed in injury to persons or property. unacceptable and shall offer the estab- (2) Notice and opportunity need not lishment the right to file an answer to be provided if the Secretary has any the original complaint and to request a reason to believe that providing such hearing with respect to the merits or notice and opportunity could result in validity of the suspension action. If any establishment so notified files an flight of a suspected violator to avoid answer to the original complaint and prosecution. requests a hearing, a copy of the com- (3) Notice and opportunity need not plaint, answer, and request for hearing be provided if the Secretary has any shall be filed with the Hearing Clerk, reason to believe that providing such who shall assign the matter a docket notice and opportunity could result in number. The proceeding shall there- compromising special investigative after be conducted in accordance with techniques, such as undercover or the rules of practice which shall be other covert operations. adopted for the proceeding. (4) Notice and opportunity need not (c) Returns written assurances which be provided when the impending crimi- the Secretary determines to be satis- nal referral involves suspicion of brib- factory, the suspension shall be termi- ery and related offenses, or clandestine nated and the establishment informed slaughtering and/or processing oper- of this action as soon as possible. ations. (5) Notice and opportunity need not Subpart E—Criminal Violations be provided when the impending referral is part of an investigation involving AUTHORITY: Sec. 406, Pub. L. 99–641, 100 Stat. 3571; 21 U.S.C. 606 note. non-Act violations, and the Act and non-Act violations are jointly referred § 335.40 Opportunity for presentation for prosecution. of views before report of criminal (b) A notice of opportunity to present violations. views will be sent by registered or cer- (a) Except as provided in paragraphs tified mail, summarize the violations (a)(1) through (5) of this section, before that constitute the basis of the con- any violation of the Federal Meat In- templated prosecution, and describe spection Act is reported to the Depart- the procedures for presentation of ment of Justice by the Secretary for views. Any information given by a re- criminal prosecution the Secretary spondent, orally or in writing, shall be- must give reasonable notice to the sus- come part of the Department’s official pected violator that the Secretary in- record concerning the matter. The De- tends to report the violation for pros- partment is under no obligation to dis- ecution and give the suspected violator close evidence to the suspected viola- an opportunity to present the violator. tor’s views to the Secretary with respect to such proceeding. [52 FR 13828, Apr. 27, 1987]

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PART 350—SPECIAL SERVICES RE- graphs 306 (b) and (c) of the Tariff Act LATING TO MEAT AND OTHER of 1930 (19 U.S.C. 1306 (b) and (c)). (h) Official establishment. An estab- PRODUCTS lishment operated under Federal meat inspection pursuant to the Meat In- Sec. 350.1 Meaning of words. spection Act, as amended (21 U.S.C. 71 350.2 Definitions. et seq.). 350.3 Types and availability of service. (i) Food article. Any article of human 350.4 [Reserved] food derived wholly or in part from 350.5 Application for service. meat, meat byproducts, or meat food 350.6 Denial or withdrawal of service. products, which is not subject to the 350.7 Fees and charges. Federal meat inspection laws, and ani- 350.8 Scope and applicability of rules of practice. mal casings, for which the mark of Federal meat inspection is requested: AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17, Provided, That such articles and cas- 2.55. ings are derived from federally in- SOURCE: 23 FR 9982, Dec. 23, 1958. Redesig- spected and passed carcasses. nated at 30 FR 4195, Mar. 31, 1965, and at 35 (j) [Reserved] FR 15554, Oct. 3, 1970. (k) Secretary. The Secretary of Agri- § 350.1 Meaning of words. culture of the United States, or any officer or employee of the Department to Words used in this part in the sin- whom authority has heretofore been gular form shall be deemed to import delegated, or may hereafter be dele- the plural, and vice versa, as the case gated, to act in his stead in connection may demand. with the function involved. § 350.2 Definitions. [23 FR 9982, Dec. 23, 1958, as amended at 25 For the purposes of the regulations FR 9642, Oct. 7, 1960; 30 FR 258, Jan. 9, 1965. Redesignated and amended at 30 FR 4195, in this part, unless the context other- Mar. 31, 1965; 32 FR 6021, Apr. 15, 1967; 32 FR wise requires, the following terms shall 13115, Sept. 15, 1967. Further redesignated at be construed, respectively, to mean: 35 FR 15554, Oct. 3, 1970, and amended at 43 (a) Department. The United States De- FR 11147, Mar. 17, 1978; 54 FR 1329, Jan. 13, partment of Agriculture. 1989] (b) Service. The Food Safety and In- spection Service of the Department. § 350.3 Types and availability of serv- (c) Administrator. The Administrator ice. of the Service or any officer or em- Upon application in accordance with ployee of the Department to whom au- § 350.5 the following types of service thority has heretofore been delegated, may be furnished under the regulations or to whom authority may hereafter be in this part: delegated, to act in his stead. (a) Identification service. (1) Meat or (d) [Reserved] other product that is federally in- (e) Inspector. Any officer or employee spected and passed at an official estab- of the Department authorized to per- lishment, or upon importation, under form any duties under the regulations the meat inspection laws, is officially in this part. marked to identify it as federally in- (f) Person. Any individual, corpora- spected and passed. In order to facili- tion, company, association, firm, part- tate the division of such meat or other nership, society, or joint stock com- product into smaller portions or its pany, or other organized group of any combination into larger units and still of the foregoing. maintain its identity as product which (g) Federally inspected and passed. In- has been federally inspected and passed spected and passed under the Meat In- and so marked, inspectors may super- spection Act, as amended (21 U.S.C. 71 vise the handling of the product and et seq.) or under the provisions in para- mark such portions or units with the

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marks of Federal inspection when they make application for service to the Ad- determine that the identity has been ministrator, upon an application form maintained. which will be furnished by the Admin- (2) At the time service is furnished istrator upon request. product must be sound, wholesome and (Approved by the Office of Management and fit for human food. The service will be Budget under control number 0583–0036) available only on premises other than [23 FR 9982, Dec. 23, 1958. Redesignated at 30 those of an official establishment. The FR 4195, Mar. 31, 1965, and at 35 FR 15554, Oct. sanitation of the plant or area where 3, 1970, and amended at 47 FR 746, Jan. 7, service is furnished must comply with 1982] applicable provisions of part 308 of this chapter. § 350.6 Denial or withdrawal of serv- (3) The mark of inspection shall be ice. applied only under the immediate su- (a) If any person has applied for serv- pervision of an inspector. ice for meat or other product not eligi- (4) The service will be available for ble therefor under the regulations in products moved in tank cars and tank this part, or has failed to make proper trucks from an official establishment application for service or to pay fees or from a location operating under this and charges due for service furnished service only if such tank cars or tank or to be furnished to him under the trucks bear a label before leaving such regulations in this part, or if the serv- official establishment or such other lo- ice cannot be furnished to any person cation, in accordance with 9 CFR applying therefor because of lack of §§ 316.14 and 317.2. available inspectors or other adminis- (b) Certification service. At the request trative reasons, the service may be de- of a purchaser, supplier, exporter, or nied to such person by the Adminis- others, inspectors may make certifi- trator until the condition justifying cation regarding livestock products for such denial is corrected. human food purposes (including cas- (b) Service under the regulations in ings), to be exported, as meeting condi- this part may also be denied to any tions or standards that are not imposed person by the Secretary for such period or are in addition to those imposed by as he may deem proper, if it is deter- the regulations in parts 301 through 331 mined, after opportunity for hearing of this chapter and the laws under before a proper official in the Depart- which such regulations were issued. ment, that such person has been re- (c) An inspec- Food inspection service. sponsible for any willful misrepresen- tion and certification service for tation to the Department concerning wholesomeness relating to the manu- any meat or other product for which facture of a food article may be fur- service has been requested under the nished upon application. All applicable regulations, in this part, or that such provisions of this chapter shall apply person has been responsible for the use to the preparation, labeling and certifi- without authority, or the imitation, of cation of the food article prepared any marks or certificates of Federal under this food inspection service. (d) [Reserved] meat inspection on or with respect to any meat or other product, or has oth- [25 FR 9642, Oct. 7, 1960, as amended at 30 FR erwise been responsible for any fraudu- 258, Jan. 9, 1965. Redesignated at 30 FR 4195, lent or deceptive practice with respect Mar. 31, 1965, and amended at 30 FR 8675, to such service, or that such person has July 9, 1965. Further redesignated at 35 FR 15554, Oct. 3, 1970, and amended at 38 FR interfered with or obstructed any in- 29215, Oct. 23, 1973; 53 FR 28634, July 29, 1988; spector in the performance of his du- 54 FR 1329, Jan. 13, 1989] ties under the regulations in this part, or attempted to do so. When the Ad- § 350.4 [Reserved] ministrator determines that the public interest so requires, he may deny or § 350.5 Application for service. withdraw service provided for in this Any person who desires to receive part, without a hearing, pending final service under the regulations in this determination of the matter. The ap- part for meat or other product eligible plicant or recipient of service involved therefor under such regulations may shall be notified of the Administrator’s

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decision to deny or suspend service and clude, but will not be limited to, the the reasons therefor, in writing, in the time required for travel of the inspec- manner prescribed in § 1.147(b) of the tor or inspectors in connection there- rules of practice (7 CFR 1.147(b)), or with during the regularly scheduled ad- orally. The Administrator’s decision to ministrative workweek. deny or suspend the service shall be ef- (d) Charges may also be made to fective upon such oral or written noti- cover the cost of travel and other ex- fication, whichever is earlier, to the penses incurred by the Service in con- applicant or recipient of service. If nection with the furnishing of the serv- such notification is oral, the Adminis- ice. trator shall confirm such decision and the reasons therefor, in writing, as [23 FR 9982, Dec. 23, 1958, as amended at 53 FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, promptly as circumstances permit, and 1989] such written confirmation shall be served upon the applicant or recipient § 350.8 Scope and applicability of rules of service, in the manner prescribed in of practice. § 1.147(b) of the rules of practice (7 CFR The rules of practice of the Depart- 1.147(b)). In other cases prior to the in- ment of Agriculture in subpart H of stitution of proceedings for denial of part I, subtitle A, title 7 of the Code of service under this paragraph, the facts Federal Regulations, are the rules of or conduct which may warrant such ac- practice applicable to adjudicatory, ad- tion shall be called to the attention of ministrative proceedings under the reg- the person involved, in writing, and he ulations in this part (9 CFR part 350). shall be given an opportunity to demonstrate or achieve compliance with [43 FR 11147, Mar. 17, 1978] all applicable requirements. PART 351—CERTIFICATION OF [23 FR 9982, Dec. 23, 1958; 25 FR 9642, Oct. 7, 1960. Redesignated at 30 FR 4195, Mar. 31, TECHNICAL ANIMAL FATS FOR 1965, and 35 FR 15554, Oct. 3, 1970, and amend- EXPORT ed at 43 FR 11147, Mar. 17, 1978] DEFINITIONS § 350.7 Fees and charges. Sec. (a) Fees and charges for service under 351.1 Meaning of words. the regulations in this part shall be 351.2 Terms defined. paid by the applicant for the service in accordance with this section, and, if re- SCOPE OF CERTIFICATION SERVICE quired by the Administrator, the fees 351.3 Kind of service. and charges shall be paid in advance. (b) The fees and charges provided for PROCEDURE FOR OBTAINING SERVICE: ADMINISTRATION OF PROGRAM in this section shall be paid by check, draft, or money order payable to the 351.4 Application for certification service. Treasurer of the United States and 351.5 Conditions of eligibility for certifi- shall be remitted promptly to the Ad- cation service; review of applications. 351.6 Official number. ministrator upon furnishing to the ap- 351.7 Administration of certification service plicant of a statement as to the program. amount due. (c) The fees to be charged and col- FEES lected for service under the regulations 351.8 Charges for surveys of plants. in this Part shall be at the rates speci- 351.9 Charges for examinations. fied in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime in- FACILITIES AND OPERATIONS cluding Saturdays, Sundays, and holi- 351.10 Facilities. days; and for certain laboratory serv- 351.11 Identification and separation of tech- ices which are not covered under the nical animal fats for certification and base time, overtime, and/or holiday materials for use therein; removal of wrappers, etc.; cleaning of equipment. costs. Such fees shall cover the costs of 351.12 Circuit supervisor to be informed the service and shall be charged for the when plant operates. time required to render such services. 351.13 Inspectors to have access to certified Where appropriate, this time will in- plants at all times.

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351.14 Processes to be supervised; extent of (e) Inspector means an employee of examinations. the Program or a cooperating State. 351.15 Reports of violations. (f) Circuit means one or more in- TRANSPORTATION AND EXPORTATION OF spected plants assigned to a circuit su- CERTIFIED TECHNICAL ANIMAL FAT pervisor. 351.16 Certificate required for shipments of (g) Recognized State means any State technical animal fat. not designated in § 331.2 of this chapter. 351.17 Identification required. (h) Cooperating State means any State cooperating under § 351.7 in administra- PROHIBITIONS tion of the regulations in this part. 351.18 Official identifications; unauthorized (i) Inspection means ante-mortem and use. post-mortem inspection by Program inspectors or inspectors of a Meat Inspec- REMEDIES; PENALTIES tion Service of a recognized State. 351.19 Refusal of certification for specific (j) Animals means cattle, sheep, lots. 351.20 Withdrawal of service from certified swine, goats, horses, mules and other plants. equines. (k) Technical animal fat means animal APPEALS fat eligible for exportation, or storage 351.21 Appeals. for exportation, in accordance with § 325.11 of this chapter. RECORDS AND REPORTS (l) Certified technical animal fat means 351.22 Certified plants to maintain records technical animal fat certified for ex- and make reports; access to records. port or storage for export under the AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 regulations in this part. (g) and (i), 2.55. (m) Tallow means technical animal SOURCE: 40 FR 58627, Dec. 18, 1975, unless fat with a minimum titre of 40 °C. otherwise noted. (n) Certified plant means any plant or storage facility preparing or storing DEFINITIONS certified technical animal fat for export, or for transfer to another cer- § 351.1 Meaning of words. tified plant or storage facility for ulti- Words used in this part in the sin- mate export, and at which certification gular form shall be deemed to import service is provided under the regula- the plural, and vice versa, as the case tions in this part. may demand. (o) Inspected and Passed means inspected and passed under the Federal § 351.2 Terms defined. Meat Inspection Act (21 U.S.C. 601 et When used in this part, unless the seq.) or the meat inspection laws of a context otherwise requires: recognized State. (a) Department means the United States Department of Agriculture. SCOPE OF CERTIFICATION SERVICE (b) Program means the Meat and Poultry Inspection Program of the § 351.3 Kind of service. Food Safety and Inspection Service of (a) Certification, in the form set the Department. forth in paragraph (b), is available (c) Administrator means the Adminis- under the regulations in this part for trator of the Food Safety and Inspec- specific lots of technical animal fat for tion Service of the Department, or any export, if the fat was rendered from officer or employee of the Department materials derived from carcasses, or to whom authority has heretofore been parts of carcasses, that had been in- delegated or may hereafter be dele- spected and passed and came from ani- gated to act in his stead. mals that did not die otherwise than by (d) Circuit supervisor means an em- slaughter under inspection. The certifi- ployee of the Program assigned to su- cation will be made by a Program em- pervise and perform official work in a ployee when he determines, upon the circuit. Such employee is assigned by basis of examinations made by him or and reports directly to the Adminis- other inspectors, as provided in § 351.14, trator or person designated by him. and information obtained by him or

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them from the exporter or other service will be available upon a vol- sources, as provided in the regulations untary fee basis in accordance with in this part, that the technical animal said regulations. fat is eligible for certification under (b)(1) The form of Certificate for Ex- this section and therefore the state- port of Technical Animal Fats is as fol- ments to be certified are correct. The lows:

(2) Certified technical animal fat made on forms1 available from the Ad- may be described on the certificate as ministrator and provide all informa- ‘‘technical animal fat’’; or if it is tal- tion called for thereon relating to the low, it may be described on the certifi- identity of the applicant and the plant, cate as ‘‘Tallow’’ and the description and the nature of the plant operations, may include the statement ‘‘titre not and a certification of specified facts less than 40 °C.’’ and an agreement to comply with specified requirements. PROCEDURE FOR OBTAINING SERVICE: (Approved by the Office of Management and ADMINISTRATION OF PROGRAM Budget under control number 0583–0036) [40 FR 58627, Dec. 18, 1975, as amended at 47 § 351.4 Application for certification FR 746, Jan. 7, 1982] service. Application for certification service § 351.5 Conditions of eligibility for cer- under the regulations in this part may tification service; review of applications. be made to the Administrator by the operator of any rendering plant or stor- (a) To be eligible for certification age facility at which technical animal service under the regulations in this fat is prepared or stored for export. In part, the operator of a rendering plant case of a change of ownership or must demonstrate that: change of location, a new application shall be made. Applications shall be 1 Copy filed as part of the original document.

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(1) He operates a rendering plant present his views prior to refusal of the which will receive materials derived service. from inspected and passed carcasses, or (Approved by the Office of Management and parts of carcasses, of animals that did Budget under control number 0583–0036) not die otherwise than by slaughter [40 FR 58627, Dec. 18, 1975, as amended at 41 under inspection, (i.e., not ‘‘dead ani- FR 12637, Mar. 26, 1976; 47 FR 746, Jan. 7, 1982] mals’’); and such source materials will be rendered at the plant into technical § 351.6 Official number. animal fat eligible for export, or stor- The Administrator will assign a cer- age for export, in accordance with the tified technical animal fat plant num- regulations in this part; ber to each plant granted service. Such (2) The source materials and the ren- number shall be preceded by the letter dered technical animal fat described in ‘‘C’’ and be used to identify all certified paragraph (a)(1) will be identified and technical animal fat prepared or stored kept separated at all times from other by the plant. products; and (3) He will comply with the applica- § 351.7 Administration of certification ble regulations in this part. service program. (b) To be eligible for certification (a) The regulations in this part shall service under the regulations in this be administered by the circuit super- part, the operator of a storage facility visor for the jurisdiction in which is lo- must demonstrate that: cated the certified plant or plants for (1) He operates a storage facility that which application for certification will receive for storage certified tech- service is made, and such assistants as nical animal fat shipped directly from may be necessary will be assigned by a certified rendering plant for storage the Administrator. for export and he will keep such ship- (b) The Administrator may enter into ments identified and separated from a cooperative agreement with any rec- other products that are not certified, ognized State for the conduct by State and he will receive such fat only if it is employees of any surveys, examina- accompanied by MP Form 85, as re- tions, and other activities involved in quired by § 351.17. the administration of the regulations (2) He will comply with the applica- in this part. However, certifications ble regulations in this part. under these regulations may be issued (c) Each applicant for certification only by Program employees, as pro- service must file with the Adminis- vided in § 351.3. trator, with the application for service, a written description of the procedures FEES to be used for receiving, identifying, processing, storing, and otherwise han- § 351.8 Charges for surveys of plants. dling technical animal fat, and mate- Applicants for the certification serv- rials for use in the preparation thereof, ice shall pay the Department for salary at the plant or storage facility in- costs at the rates specified in §§ 391.2 volved, and for shipping technical ani- and 391.3 respectively for base time, mal fat from the plant or facility and and for overtime, travel, and per diem storing and exporting such technical allowances at rates currently allowed animal fat, and a written description of by the Federal Travel Regulations, and the shipping, receiving, and inventory other expenses incidental to the initial records maintained for technical ani- survey of the rendering plants or stor- mal fat. age facilities for which certification (d) The Administrator will deter- service is requested. mine, on the basis of all information available to him, whether the arrange- [54 FR 6389, Feb. 10, 1989] ments at the plant or storage facility are such as will assure that certifi- § 351.9 Charges for examinations. cations of technical animal fat will be (a) The fees to be charged and col- correct, and, if so, will grant the appli- lected by the Administrator for exam- cation for certification service. An ap- ination shall be at the rates specified plicant will be given an opportunity to in §§ 391.2, 391.3, and 391.4 respectively

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for base time; for overtime including plant and throughout processing or Saturdays, Sundays, and holidays, as handling at such plant. All wrappers provided for in § 351.14; and for certain and packaging shall be removed from laboratory services which are not cov- the source materials to the fullest ex- ered under the base time, overtime, tent practicable before the materials and/or holiday costs and which are re- are rendered at the plant. quired to determine the eligibility of (b) If a plant’s operations are within any technical animal fat for certifi- the provisions of § 351.14(b)(3), all equip- cation under the regulations in this ment shall be cleaned before it is used Part. Such fees shall be charged for the for receiving, preparation, or storage of time required to render such service, certified technical animal fats or mate- including, but not limited to, the time rial to be used in preparation of such required for the travel of the inspector fats. Such cleaning shall be done in or inspectors in connection therewith. such manner as to prevent contamina- (b) Charges may also be made to tion of such certified fats or source ma- cover the actual cost of travel and per terial with materials that are unac- diem allowance at rates currently al- ceptable under § 351.3. lowed by the General Services Admin- istration, and other expenses incurred § 351.12 Circuit supervisor to be in- by the Department in connection with formed when plant operates. such examinations and laboratory serv- The operator of each certified plant ice. shall inform the circuit supervisor, in [40 FR 58627, Dec. 18, 1975, as amended at 53 advance, when the plant’s work sched- FR 13397, Apr. 22, 1988; 54 FR 6389, Feb. 10, ule will include preparing technical 1989] animal fats for certification and identify the approximate days and hours FACILITIES AND OPERATIONS when operations will begin and end. § 351.10 Facilities. § 351.13 Inspectors to have access to (a) Facilities for the preparation, certified plants at all times. identification, and storage of the tech- For the purpose of administering the nical animal fat to be certified shall be regulations in this part, inspectors furnished and maintained by the cer- shall have access at all times by day or tified plant in accordance with this night to every part of a certified plant. section. (b) The operator of the certified plant § 351.14 Processes to be supervised; ex- shall provide at the plant, rooms, com- tent of examinations. partments, and equipment needed to maintain the identity of certified tech- (a) All processes used in the prepara- nical animal fats and materials used in tion of certified technical animal fats their preparation, and separation of at any certified plant shall be subject such articles from other products. Such to supervision by an inspector. Cer- rooms, compartments, and equipment tified plants shall not prepare any shall be conspicuously marked with the technical animal fat for certification phrase ‘‘Certified Technical Animal under the regulations in this part, ex- Fat’’ whenever they contain these fats. cept in accordance with such regulations. § 351.11 Identification and separation (b) Supervision, ranging from full- of technical animal fats for certifi- time coverage of an entire process to cation and materials for use there- one or more reviews per month, to de- in; removal of wrappers, etc.; clean- termine a plant’s compliance with the ing of equipment. regulations in this part will be main- (a) All technical animal fat to be of- tained. A circuit supervisor may in- fered for certification under this part crease the frequency of reviews when- and materials to be used in the prepa- ever he deems necessary to assure the ration of such fat, and all certified validity of certifications under the reg- technical animal fat, shall be identified ulations in this part. Usual coverage of and kept separate from other products individual rendering plants will be as from the time of receipt at a certified follows:

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(1) Coverage shall be at least once a § 351.17 Identification required. month if the plant consistently handles Certified technical animal fats being only raw materials acceptable under exported directly from a certified plant § 351.3 for the preparation of certified or transferred between certified plants technical animal fat and the plant op- for storage for export are subject to the erator, in writing, certifies that he is requirements of § 325.11 of this chapter. maintaining this procedure. In addition, such shipments between (2) Coverage shall be at least once a certified plants shall be accompanied week if the plant consistently handles by MP Form 85 (Declaration to Accom- some raw materials that are accept- pany Technical Animal Fats Between able, and some that are unacceptable, Certified Technical Animal Fat under § 351.3, for the preparation of cer- Plants) 2 prepared by the operator of tified technical animal fat, uses sepa- the certified plant from which ship- rate equipment for processing, and uses ment is made, certifying that the prod- separate rooms, compartments, and uct has been obtained by rendering raw equipment for receiving and storing materials derived from federally or the respective types of raw materials State inspected and passed carcasses, and technical animal fats, and the or parts of carcasses. Technical animal plant operator, in writing, certifies fat described on MP Form 85 as tallow that he is maintaining this complete must meet the definition of ‘‘Tallow’’ in § 351.2. physical separation procedure. (3) Coverage shall be fulltime during PROHIBITIONS receiving of raw materials and their preparation into certified technical § 351.18 Official identifications; unau- animal fat, if the plant handles some thorized use. raw materials that are acceptable, and (a) The form of certification set forth some that are unacceptable, under in § 351.3 and the term ‘‘Certified Tech- § 351.3, for the preparation of certified nical Animal Fat’’ are official identi- technical animal fat, and uses the same fications for purposes of the Agricul- rooms, compartments, and equipment, tural Marketing Act of 1946, as amend- with only time separation between reed, and shall not be falsely made, is- ceiving, processing, and storing the re- sued, altered, forged, or counterfeited, spective types of raw materials and or used for purpose of misrepresenta- technical animal fats. tion or deception. (b) No container which bears or is to § 351.15 Reports of violations. bear any designation as certified technical animal fat shall be filled in whole Inspectors shall report to the circuit or in part, except with technical ani- supervisor any apparent violations of mal fats which have been certified and the regulations in this part or the Fed- identified in compliance with this part. eral Meat Inspection Act or regulations thereunder (subchapter A of this chap- REMEDIES; PENALTIES ter) which occur at certified plants, or elsewhere, within their knowledge. The § 351.19 Refusal of certification for circuit supervisor shall report such ac- specific lots. tions to the Administrator through ap- If an inspector has reason to believe propriate channels. that a lot of technical animal fat is ineligible for certification under § 351.3, TRANSPORTATION AND EXPORTATION OF or any materials to be used in a lot of CERTIFIED TECHNICAL ANIMAL FAT technical animal fat would make the technical animal fat ineligible for such § 351.16 Certificate required for ship- certification, certification of the lot ments of technical animal fat. shall be withheld pending final deter- No certified plant shall export any mination by the circuit supervisor. The certified technical animal fat unless operator of the plant shall be afforded the shipment is accompanied by a cer- 2 tificate issued under § 351.3. Copy filed as part of the original document.

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an opportunity to demonstrate the eli- in § 1.147(b) of the rules of practice (7 gibility of the lot for certification be- CFR 1.147(b)). fore the final determination is made. (c) The rules of practice of the De- partment of Agriculture in subpart H § 351.20 Withdrawal of service from of part I, subtitle A, title 7 of the Code certified plants. of Federal Regulations, are the rules of (a) After opportunity for hearing has practice applicable to adjudicatory, ad- been accorded the operator of a cer- ministrative proceedings under the reg- tified plant, the certification service, ulations in this part (9 CFR Part 351). provided for in this part, may be withdrawn from such plant in accordance [40 FR 58627, Dec. 18, 1975, as amended at 43 with the applicable rules of practice, if FR 11148, Mar. 17, 1978] it is determined that: (1) The operator, or his employee or APPEALS agent: (i) Has made any willful misrepresen- § 351.21 Appeals. tation or engaged in any fraudulent or Any decision by an employee of the deceptive practice in connection with Program may be appealed by any ad- the service; versely affected person to the imme- (ii) Has interfered with or obstructed diate supervisor of such employee. De- any Program employee or other inspec- cisions of other inspectors may be ap- tor in the performance of his duties, pealed to the circuit supervisor. under the regulations in this part, by intimidation, threats, or other im- RECORDS AND REPORTS proper means; or (iii) Has violated section 203(h) of the § 351.22 Certified plants to maintain Agricultural Marketing Act of 1946, as records and make reports; access to amended (7 U.S.C. 1622(h)), or any regu- records. lation in this part; or (a) Each day a certified plant pre- (2) Facilities or procedures at the pares, receives, or ships certified tech- certified plant do not conform to the nical animal fat or receives material arrangements approved by the Admin- for use in such product, the operator of istrator under § 351.5. the plant shall prepare records identi- (b) Pending final determination of fying the kinds and quantities of such the matter, the Administrator may materials and technical animal fats re- summarily suspend the certification service at any certified plant when he ceived, the number of pounds of cer- has reason to believe that there is tified technical animal fat prepared or cause for withdrawal of the service shipped, and an up-to-date inventory of under paragraph (a). The operator of certified technical animal fats in stor- the certified plant shall be notified of age. The operator of each certified the Administrator’s decision to sus- plant shall include in the records re- pend summarily the certification serv- quired by this section all MP Forms 85 ice at such plant and the reasons there- which he receives with shipments of for, in writing, in the manner pre- certified technical animal fat from any scribed in § 1.147(b) of the rules of prac- other certified plant. These records tice (7 CFR 1.147(b)), or orally. The Ad- shall be maintained by the operator of ministrator’s decision to suspend sum- each certified plant and made available marily the certification service shall to an inspector, upon request, for ex- be effective upon such oral or written amination and copying, for a period of notification, whichever is earlier, to 1 year after the date of the transaction the operator of the certified plant. If involved. such notification is oral, the Adminis- (b) The operator of each certified trator shall confirm such decision, and plant shall provide such relevant infor- the reasons therefor, in writing, as mation as any inspector may request promptly as circumstances permit, and to enable him to determine whether such written confirmation shall be any technical animal fats are eligible served upon the operator of the cer- for certification and whether the plant tified plant, in the manner prescribed

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is eligible for certification service (d) Applicant means any interested under the regulations in this part. party who requests any inspection service. (Approved by the Office of Management and Budget under control number 0583–0036) (e) Bison means any American bison or catalo or cattalo. [40 FR 58627, Dec. 18, 1975, as amended at 47 (f) Buffalo means any animal belong- FR 746, Jan. 7, 1982] ing to the buffalo family. (g) Catalo or Cattalo means any hy- PART 352—EXOTIC ANIMALS; brid animal with American bison ap- VOLUNTARY INSPECTION pearance resulting from direct cross- breeding of American bison and cattle. Sec. (h) Condition means any condition, 352.1 Definitions. including, but not limited to, the state 352.2 Type of service available. of preservation, cleanliness, or sound- 352.3 Application by official exotic animal ness of any product or the processing, establishment for inspection service. handling, or packaging which may af- 352.4 Application for ante-mortem inspec- fect such product. tion service in the field. 352.5 Fees and charges. (i) Condition and wholesomeness means 352.6 Denial or withrawal of inspection serv- the condition of any product, its ice. healthfulness and fitness for human 352.7 Marking inspected products. food. 352.8 Time of inspection in the field and in (j) Deer means any member of the an official exotic animal establishment. deer family. 352.9 Report of inspection work. (k) Exotic animal means any reindeer, 352.10 Ante-mortem inspection. elk, deer, antelope, water buffalo or 352.11 Post-mortem inspection. bison. 352.12 Disposal of diseased or otherwise (l) Elk means any American elk. adulterated carcasses and parts. (m) Exotic animal inspection service 352.13 Handling and disposal of condemned means the personnel who are engaged or other inedible exotic animal products at official exotic animal establishments. in the administration, application, and 352.14 Entry into official establishments; re- direction of exotic animal inspection inspection and preparation of products. programs and services pursuant to the 352.15 Records, registration and reports. regulations in this part. 352.16 Exports. (n) Exotic animal producer means any 352.17 Transportation. interested party that engages in the 352.18 Cooperation of States in Federal pro- raising and/or marketing of an exotic grams. animal for commercial purposes. (o) Field ante-mortem inspection means AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 the ante-mortem inspection of an ex- (g) and (i), 2.55. otic animal away from the official ex- SOURCE: 50 FR 41847, Oct. 16, 1985, unless otic animal establishment’s premises. otherwise noted. (p) Field designated area means any designated area on the applicant’s § 352.1 Definitions. premises, approved by the Regional Di- The definitions in § 301.2, not other- rector, where field ante-mortem in- wise defined in this part, are incor- spection is to be performed. porated into this part. In addition to (q) Identify means to apply official those definitions, the following defini- identification to products or contain- tions will be applicable to the regula- ers. tions in this part. (r) Inspection means any inspection (a) Act means the applicable provi- by an inspector to determine, in ac- sions of the Agricultural Marketing cordance with regulations in this part, Act of 1946, as amended (60 Stat. 1087, (1) the condition and wholesomeness of as amended; 7 U.S.C. 1621 et seq.). an exotic animal, or (2) the condition (b) Acceptable means suitable for the and wholesomeness of edible product of purpose intended and acceptable to the an exotic animal at any state of the Food Safety and Inspection Service. preparation or packaging in the official (c) Antelope means any animal be- plant where inspected and certified, or longing to the antelope family. (3) the condition and wholesomeness of

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any previously inspected and certified and the processing of exotic animal product of an exotic animal if such products. All provisions of this part product has not lost its identity as an shall apply to the slaughter of exotic inspected and certified product. animals, and the preparation, labeling, (s) Interested party means any person and certification of the exotic animal financially interested in a transaction meat and exotic animal products proc- involving any inspection. essed under this exotic animal inspec- (t) Official exotic animal establishment tion service. means any slaughtering, cutting, (b) Only exotic animals which have boning, curing, smoking, salting, pack- had ante–mortem inspection as de- ing, rendering, or similar establish- scribed under this part and which are ment at which inspection is main- processed in official exotic animal es- tained under the regulations in this tablishments in accordance with this part. part may be marked inspected and (u) Official device means a stamping passed. appliance, branding device, stencil (c) Exotic animals, exotic animal printed label, or any other mechani- meat and meat food products shall be cally or manually operated tool that is handled in an official exotic animal es- approved by the Administrator for the tablishment to ensure separation and purpose of applying any official mark identity of the exotic animal or exotic or other identification to any product animal meat and meat food products or packaging material. until they are shipped from the official (v) Official identification means any exotic animal establishment to prevent symbol, stamp, label or seal indicating commingling with other species. that the product has been officially inspected and/or indicating the condition [54 FR 1330, Jan. 13, 1989] of the product approved and authorized by the Administrator to be affixed to § 352.3 Application by official exotic any product, or affixed to or printed on animal establishment for inspection services. the packaging material of any product. (w) Program means the Voluntary Ex- (a) Any person desiring to process an otic Animal Inspection Program of the exotic animal, exotic animal carcasses, Food Safety and Inspection Service. exotic animal meat and meat food (x) Reindeer means any reindeer com- products in an establishment under ex- monly referred to as caribou. otic animal inspection service must re- (y) Transport vehicle means any vehi- ceive approval of such establishment cle used to transport an exotic animal. and facilities as an official exotic ani- (z) Veterinarian means an authorized mal establishment prior to the ren- veterinarian of the Program employed dition of such service. An application by the Department or any cooperating for inspection service to be rendered in State who is authorized by the Sec- an official exotic animal establishment retary to do any work or perform any shall be approved in accordance with duty in connection with the Program. the provisions contained in §§ 304.1 and (aa) Water buffalo means any Asiatic 304.2 of subchapter A of this chapter. water buffalo, commonly referred to as (b) Initial survey. When an applica- carabao; and the water buffalo of India, tion has been filed for exotic animal in- commonly referred to as the Indian spection service, the Regional Director buffalo. or designee, shall examine the establishment, premises, and facilities. [54 FR 1330, Jan. 13, 1989] [54 FR 1331, Jan. 13, 1989] § 352.2 Type of service available. Upon application, in accordance with § 352.4 Application for ante-mortem in- § 352.3, § 352.4, and § 352.5, the following spection service in the field. type of service may be furnished under Any exotic animal producer desiring the regulations in this part: field ante-mortem exotic animal in- (a) Voluntary Inspection Service. An spection service must receive approval inspection and certification service for of the field ante-mortem designated wholesomeness relating to the slaugh- area from the Regional Director or des- ter and processing of exotic animals ignee prior to the rendition of such

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service. An application seeking ap- or inspectors in connection therewith proval of the designated area for ante- during the regularly scheduled admin- mortem inspection shall be obtained istrative workweek. from the Regional Director, and com- (d) Charges may also be made to pleted and submitted to the Regional cover other expenses incurred by the Director. Service in connection with the furnish- (a) An initial application for field ing of the service. ante-mortem exotic animal inspection (e) Fees and charges for any inspec- service shall be made by an official ex- tion pursuant to a cooperative agree- otic animal establishment to the Re- ment with any State shall be paid in gional Director. Subsequent requests accordance with the terms of such co- shall be made by the official exotic ani- operative agreement. mal establishment on behalf of an ex- [50 FR 41847, Oct. 16, 1988, as amended at 53 otic animal producer to the Regional FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, Director in one of the following man- 1989] ners: (1) telephone, (2) telegraph, (3) mail, or (4) in person as determined by § 352.6 Denial or withdrawal of inspec- the Regional Director. tion service. (b) Upon receipt of the completed ap- (a) For miscellaneous reasons. An application, the Regional Director or des- plication or a request for service may ignee shall examine the field ante- be rejected, or the benefits of the serv- mortem designated area and facilities ice may be otherwise denied to, or for approval of the designated area. withdrawn from, any person, without a (c) All fees involved for the approval hearing by the appropriate Regional of the designated area, including but Director: (1) for administrative reasons not limited to any travel, per diem such as the nonavailability of person- costs, and time required to perform nel to perform the service; (2) for the such approval services, shall be paid di- failure of payment for service; (3) in rectly by the applicant to the Regional case the application or request relates Director. to exotic animals or exotic animal [54 FR 1331, Jan. 13, 1989] products which are not eligible for service under this part; (4) for failure § 352.5 Fees and charges. to maintain the designated area or the (a) Fees and charges for service under plant in a state of repair approved by the regulations in this part shall be the Service; (5) for the use of operating paid by the applicant for the service in procedures which are not in accordance accordance with this section. with the regulations of this part; (6) for (b) The fees and charges provided for alterations of buildings, facilities, or in this section shall be paid by check, equipment which cannot be approved draft, or money order payable to the under the regulations in this part. No- ‘‘Treasurer of the United States’’ and tice of such rejection, denial, or with- shall be remitted promptly to the Re- drawal, and the reasons therefore, shall gional Director upon furnishing to the promptly be given to the person in- applicant a statement as to the volved. The applicant or recipient shall amount due. be notified of such decision to reject an (c) The fees to be charged and col- application or request for service or to lected for service under the regulations deny or withdraw the benefits of the in this part shall be at the rates speci- service, and the reasons therefor, in fied in §§ 391.2, 391.3, and 391.4 respec- writing in the manner prescribed in tively for base time; for overtime in- § 1.147(b) of the rules of practice (7 CFR cluding Saturdays, Sundays, and holi- 1.147(b)), or orally. Such decision shall days; and for certain laboratory serv- be effective upon such oral or written ices which are not covered under the notification, whichever is earlier, to base time, overtime, and/or holiday the applicant or recipient. If such noti- costs. Such fees shall cover the costs of fication is oral, the person making the service and shall be charged for the such decision shall confirm such deci- time required to render such service, sion, and the reasons therefor, in writ- including, but not limited to, the time ing, as promptly as circumstances per- required for the travel of the inspector mit, and such written confirmation

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shall be served upon the applicant or who has any authority with respect to recipient in the manner prescribed in the location where service is or would § 1.147(b) of the rules of practice (7 CFR be performed; or in case the service is 1.147(b)). or would be performed with respect to (b) For disciplinary reasons—Basis for any exotic animal or exotic animal denial or withdrawal. An application or product in which any person or entity, request for service may be denied, or from whom the benefits of service are the benefits of the service may be with- currently being denied or have been drawn from, any person or entity who, withdrawn under this part, has con- or whose officer, employee or agent in tract or other financial interest. the scope of his employment or agency: (c) Procedure. (1) An application or re- (1) Has willfully made any misrepresen- quest for service may be denied or ben- tation or has committed any other efits of the service may be withdrawn fraudulent or deceptive practice in con- by the Secretary, as provided by para- nection with any application or request graph (b) of this section, after notice for service under this part; (2) has and opportunity for hearing before a given or attempted to give, as a loan or designated official of the Department. for any other purpose, any money, The Administrator may suspend serv- favor or other thing of value, to any ice under this paragraph without hear- employee or agent of the Department ing, pending final determination of the or a cooperating State authorized to matter, when he determines that the perform any function under this part; public health, interest or safety so re- (3) has interfered with or obstructed, or quires. The applicant or recipient shall attempted to interfere with or to ob- be notified of the Administrator’s deci- struct, any employee or agent of the sion to suspend service, and the rea- Department or cooperating State in sons therefor, in writing or orally. The the performance of his or her duties Administrator’s decision to suspend under this part by intimidation, service under this part shall be effec- threats, assaults, abuse, or any other tive upon such an oral or written noti- improper means; (4) has knowingly rep- fication, whichever is earlier, to the resented that any exotic animal car- applicant or recipient. If such notifica- cass, or exotic animal product, has tion is oral, the Administrator shall been officially inspected and passed by confirm such decision, and the reasons an authorized inspector under this therefor, in writing, as promptly as cir- part, when it had not, in fact, been so cumstances permit, and such written inspected; (5) has been convicted of confirmation shall be served upon the more than one misdemeanor under any applicant or recipient in the manner law based upon the acquiring, han- prescribed in 1.147(b) of Departmental dling, or distributing of adulterated, rules of practice (7 CFR 1.147(b)). mislabeled, or deceptively packaged (2) The written notification specified good, or fraud in connection with in paragraph (c) of this section, which transactions in food, or any felony; shall constitute the complaint in the Provided, an application or a request proceeding, shall briefly set forth the for service made in the name of a per- reason for the denial or withdrawal of son or entity otherwise eligible for service, including allegations of fact service under the regulations may be which constitute a basis for the action. denied, or the benefits of the service After the complaint is served upon the may be withdrawn, from such a person respondent, as provided in § 1.147(b) of or entity in case the service is or would Departmental rules of practice (7 CFR be performed at a location operated by 1.147(b)), the proceeding shall there- a person or entity, from whom the ben- after be conducted in accordance with efits of the service are currently being rules of practice which shall be adopted denied or have been withdrawn under for the proceeding. this part; or by a person or entity hav- [50 FR 41847, Oct. 16, 1985, as amended at 54 ing an officer, director, partner, man- FR 1331, Jan. 13, 1989] ager or substantial investor from whom the benefits of service under this § 352.7 Marking inspected products. part are currently being denied or have Wording and form of inspection been withdrawn under this part, and mark. Except as otherwise authorized

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by the Administrator, the inspection example below.1 The establishment mark applied to inspected and passed number of the official establishment exotic animal carcasses, meat or meat shall be set forth if it does not appear food products under this part shall in- on the packaging material or con- clude wording as follows: ‘‘Inspected tainer. and Passed by U.S. Department of Ag- (1) For application to exotic animal riculture.’’ This wording shall be con- carcasses, primal parts and cuts there- tained within a triangle in the form from, exotic animal livers, exotic ani- and arrangement shown in this section. mal tongues, and exotic animal hearts. The establishment number of the official establishment shall be included in the triangle unless it appears elsewhere on the packaging material. Ordering and manufacture of the triangle brand shall be in accordance with the provisions in 9 CFR 317.3(c) of the Federal meat inspection regulations. The Ad- ministrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation shall be applied, under the supervision of the inspector, to the inspected and passed edible product, packaging material, immediate container or shipping container. When the inspection mark or (2) For application to exotic animal approved abbreviation is used on pack- calf carcasses. aging material, immediate container or shipping container, it shall be printed on such material or container or on a label to be affixed to the packaging material or container. The name and address of the packer or distributor of such product shall be printed on the packaging material or label. The inspection marks may be stenciled on the container, and when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or rubber stamp. The name and address of the packer or distributor, if prominently shown elsewhere on the packaging material or container, may be (3) For application to exotic animal omitted from insert labels which bear tails. an official identification if the applicable establishment number is shown. (a) The inspection mark to be applied to inspected and passed carcasses and parts of carcasses of an exotic animal, 1 The number ‘‘38’’ is given as an example and products as therefrom approved by only. The establishment number of the offi- the Administrator, shall be in the form cial exotic animal establishment where the product is prepared shall be used in lieu and arrangement as indicated in the thereof.

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(4) For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses.

(2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp. (3) The official inspection legend described in paragraph (b)(1) of this section shall also be used on shipping containers, bond labels, artificial casings, and other articles with the approval of the Administrator. (c) Any brand, stamp, label or other device approved by the Administrator and bearing any official mark prescribed in paragraph (a) or (b) of this section shall be an official device for purposes of the Act. [50 FR 41847, Oct. 16, 1985, as amended at 54 FR 1331, Jan. 13, 1989] (b) The official inspection mark to be shown on all labels.1 (1) For inspected § 352.8 Time of inspection in the field and in an official exotic animal es- and passed products of an exotic ani- tablishment. mal shall be in the following form, except that it need not be of the size il- The official exotic animal establish- lustrated, provided that it is a suffi- ment on behalf of the applicant shall cient size and of such color as to be notify the Regional Director or des- conspicuously displayed and readily ignee, in advance, of the hours when legible and the same proportions of let- such inspection is desired. Inspection ter size and boldness are maintained as personnel shall have access at all times to every part of any field ante-mortem illustrated: inspection area and/or official exotic animal establishment to which they are assigned. [54 FR 1332, Jan. 13, 1989]

§ 352.9 Report of inspection work. Reports of the work of inspection 1 The number ‘‘38’’ is given as an example carried on within the field ante- only. The establishment number of the offi- mortem inspection area of an exotic cial exotic animal establishment where the animal producer’s premises and/or offi- product is prepared shall be used in lieu cial exotic animal establishment shall thereof. be forwarded to the Administrator by

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the ante-mortem inspector. The appli- not pass ante-mortem inspection must cant for such inspection shall furnish be withheld from slaughter. to the Administrator such information (5) Stunning to render the animal un- as may be required on forms provided conscious shall be in accordance with 9 by the Administrator. CFR 313.15 or 313.16. [54 FR 1333, Jan. 13, 1989] (6) All stunned/slaughtered and bled exotic animals shall be tagged with a § 352.10 Ante-mortem inspection. ‘‘U.S. Suspect’’ tag in an ear by the An ante-mortem inspection of an ex- ante-mortem inspector or designee otic animal shall, where and to the ex- prior to loading on the transport vehi- tent considered necessary by the Ad- cle. ministrator and under such instruc- (7) The transport of intact exotic ani- tions as he may issue from time to mal carcasses to an official exotic ani- time, be made on the day of slaughter mal establishment for post-mortem in- of an exotic animal, in one of the fol- spection shall be as expedient as pos- lowing listed ways or as determined by sible, and must be within the same day the Administrator. Humane handling as field slaughter. of an exotic animal during ante- mortem inspection shall be in accord- (8) Ante-mortem cards (Form MP ance with the provisions contained in 9 402–2) shall be filled out by the ante- CFR 313.2. Immediately after the ani- mortem inspector. One copy is to be re- mal is stunned or killed, it shall be tained by the ante-mortem inspector. shackled, hoisted, stuck and bled. The other copy shall accompany the (a) To be performed on an exotic ani- transport vehicle to the official exotic mal in the field in a designated area of animal establishment and shall be de- an exotic animal producer’s premises. livered to the post-mortem veterinar- (1) Reindeer, elk, deer, antelope, ian. bison and water buffalo are eligible for (9) The ante-mortem inspector shall field ante-mortem inspection. The field supervise all phases of field ante- ante-mortem designated area must be mortem inspection. approved by the Regional Director or (b) To be performed on exotic ani- designee prior to rendition of the serv- mals that are inside of the transport ice. vehicle at an official exotic animal es- (2) Any person who desires to receive field ante-mortem inspection must pro- tablishment. vide: (1) Reindeer, elk, deer, antelope, (i) Notification from an official ex- bison, and water buffalo are eligible for otic animal establishment to the Re- transport vehicle inspection. gional Director or designee. (2) The ante-mortem inspector shall (ii) A field ante-mortem designated remain outside the transport vehicle area. while performing ante-mortem inspec- (iii) A stunning/slaughtering area tion. which is in a condition that minimizes (3) The person requesting transport the possibility of soiling the animal vehicle inspection must provide a when stunned/slaughtered and bled as transport vehicle that is as sanitary as determined by the inspector. practicable and that would safely and (iv) A transport vehicle that is as thoroughly permit the inspection of an sanitary as practicable as determined exotic animal from outside of the by the inspector. transport vehicle as determined by the (3) The ante-mortem inspector shall inspector. determine the acceptableness and safety of performing field ante-mortem in- (4) The ante-mortem inspector shall spection. If, in the opinion of the ante- determine the adequacy and safety of mortem inspector, an unsafe cir- performing ante-mortem inspection. If, cumstance exists at the time of field in the ante-mortem inspector’s opin- ante-mortem inspection, the service ion, the transport vehicle is not ade- shall be denied. quate or safe to perform ante-mortem (4) An exotic animal that, in the inspection, the service shall be denied. ante-mortem inspector’s opinion, does

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(c) To be performed in pens at official § 352.16 Exports. exotic animal establishments. The in- This shall be conducted in accord- spection shall be conducted in accordance with the provisions contained in 9 ance with the provisions contained in 9 CFR 322.1 through 322.5. CFR part 309. [54 FR 1333, Jan. 13, 1989] § 352.17 Transportation. This shall be conducted in accord- § 352.11 Post-mortem inspection. ance with the provisions contained in (a) Post-mortem inspection of rein- §§ 325.1 through 325.21. deer, elk, deer, antelope, bison and water buffalo shall be conducted in ac- § 352.18 Cooperation of States in Fed- cordance with the provisions contained eral programs. in 9 CFR part 310 or as determined by Under the ‘‘Talmadge-Aiken Act’’ of the Administrator. September 28, 1962 (7 U.S.C. 450), the (b) The post-mortem examination of Administrator is authorized to utilize field ante-mortem-inspected exotic ani- employees and facilities of States in mals must occur in the shortest length carrying out Federal functions. of time practicable and on the day that field ante-mortem inspection is per- PART 354—VOLUNTARY INSPEC- formed to minimize the changes in the TION OF RABBITS AND EDIBLE carcass which can affect the post- PRODUCTS THEREOF mortem examination, disposition and wholesomeness of the carcass and its GENERAL parts. Sec. (c) The post-mortem veterinarian 354.1 Definitions. shall inspect and make the disposition 354.2 Designation of official certificates, of all incoming ‘‘U.S. Suspect’’ tagged memoranda, marks, other identifica- exotic animals. tions, and devices for purposes of the Ag- ricultural Marketing Act. [54 FR 1333, Jan. 13, 1989] ADMINISTRATION § 352.12 Disposal of diseased or otherwise adulterated carcasses and 354.3 Administration. parts. BASIS OF SERVICE This shall be conducted in accord- 354.10 Inspection service. ance with the provisions contained in 9 354.12 Eligibility. CFR part 311. 354.13 Supervision. 354.14 Authority to waive provisions of § 352.13 Handling and disposal of con- § 354.12. demned or other inedible exotic animal products at official exotic PERFORMANCE OF SERVICES animal establishments. 354.20 Licensed or authorized inspectors. This shall be conducted in accord- 354.21 Suspension of license; revocation. ance with the provisions contained in 9 354.22 Surrender of license. CFR part 314. 354.23 Identification. 354.24 Financial interest of inspectors. 354.25 Political activity. § 352.14 Entry into official establish- 354.26 Schedule of operation of official ments; reinspection and prepara- plants. tion of products. This shall be conducted in accord- APPLICATION FOR INSPECTION SERVICE ance with the provisions contained in 9 354.30 Who may obtain inspection service. CFR 318.1, 318.2, and 318.3. 354.31 How application for service may be made; conditions of resident service. § 352.15 Records, registration, and re- 354.32 Filing of application. ports. 354.33 Authority of applicant. 354.34 Application for inspection service in This shall be conducted or main- official plants; approval. tained in accordance with the provi- 354.35 Rejection of application. sions contained in 9 CFR 320.1 through 354.36 Withdrawal of application. 320.7. 354.38 Suspension of plant approval.

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VIOLATIONS 354.126 Carcasses held for further examination. 354.45 Denial of service. 354.127 Condemnation and treatment of car- 354.46 Misrepresentation; deceptive or casses. fraudulent acts or practices. 354.128 Certification of carcasses. 354.47 Use of facsimile forms. 354.48 Willful violation of the regulations. DISPOSITION OF DISEASED RABBIT CARCASSES 354.49 Interfering with an inspector or em- AND PARTS ployee of Service. 354.51 Miscellaneous. 354.129 General. 354.130 Diseases or conditions evident which OTHER APPLICABLE REGULATIONS require condemnation. 354.131 Decomposition. 354.53 Other applicable regulations. 354.132 Disposal of condemned carcasses and parts. IDENTIFYING AND MARKING PRODUCTS 354.60 Approval of official identification. REINSPECTION AND INGREDIENTS 354.62 Inspection mark with respect to prod- 354.133 Reinspection of edible products; in- uct. gredients. 354.63 Marking inspected products. 354.64 Form of official identification. APPEALS 354.65 Form of inspection mark. 354.134 Appeal inspections; how made.

SUPERVISION OF MARKING AND PACKAGING INSPECTION CERTIFICATES 354.70 Evidence of label approval. 354.140 Forms of inspection certificates. 354.71 Affixing of official identification. 354.141 Issuance and disposition of rabbits 354.72 Packaging. inspection certificates. 354.73 Retention labels. 354.142 Food product inspection certificates; 354.74 Prerequisites to inspection. issuance and disposition. 354.75 Accessibility of products. 354.143 Export certificates; issuance and dis- 354.76 Time of inspection in an official position. plant. 354.144 Advance information.

REPORTS BASIS OF ACCEPTABILITY OF OTHER OFFICIAL 354.90 Report of inspection work. INSPECTION SYSTEMS 354.91 Information to be furnished to inspec- 354.160 General. tors. 354.161 Requirements as to manner of in- 354.92 Reports of violations. spection. 354.162 Determining compliance with FEES AND CHARGES § 354.161. 354.100 Payment of fees and charges. 354.101 On a fee basis. SANITARY REQUIREMENTS 354.105 Fees for additional copies of inspec- GENERAL tion certificates. 354.106 Travel expenses and other charges. 354.210 Minimum standards for sanitation, 354.107 Continuous inspection performed on facilities, and operating procedures in of- a resident basis. ficial plants. 354.109 Fees or charges for inspection service performed under cooperative agree- BUILDINGS AND PLANT FACILITIES ment. 354.220 Buildings. 354.110 Disposition of fees for inspection 354.221 Rooms and compartments. made under cooperative agreement. 354.222 Floors, walls, ceilings, etc. 354.223 Drainage and plumbing. INSPECTION PROCEDURES; ANTE-MORTEM 354.224 Water supply. INSPECTIONS 354.225 Lavatory accommodations. 354.120 Manner of handling products in an 354.226 Lighting and ventilation. official plant. QUIPMENT AND UTENSILS 354.121 Ante-mortem inspection. E 354.122 Condemnation on ante-mortem in- 354.230 Equipment and utensils. spection. 354.231 Accessibility. 354.123 Segregation of suspects on ante- 354.232 Restrictions on use. mortem inspection. 354.124 Quarantine of diseased rabbits. MAINTENANCE OF SANITARY CONDITIONS AND PRECAUTIONS AGAINST CONTAMINATION OF POST-MORTEM INSPECTION PRODUCTS 354.125 Evisceration. 354.240 General.

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354.241 Cleaning of rooms and compart- essing, handling, or packaging which ments. may affect such product. 354.242 Cleaning of equipment and utensils. (j) Condition and wholesomeness means 354.243 Operations and procedures. the condition of any product, its 354.244 Temperatures and cooling and freezing procedures. healthfulness and fitness for human 354.245 Vermin. food. 254.246 Exclusion of diseased persons. (k) Department means the United 354.247 Table showing types of materials. States Department of Agriculture. 354.248 Scope and applicability of rules of (l) Edible product means any product practice. derived from ready-to-cook domestic AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 rabbits. (g) and (i), 2.55. (m) Giblets means the liver from SOURCE: 41 FR 23702, June 11, 1976, unless which the bile sac has been removed otherwise noted. and the heart from which the peri- cardial sac has been removed. GENERAL (n) Holiday or legal holiday shall mean the legal public holidays specified by § 354.1 Definitions. the Congress in paragraph (a) of sec- Unless the context otherwise re- tion 6103, Title 5, of the United States quires, the following terms shall have Code. the following meaning: (o) Identify means to apply official (a) Act means the applicable provi- identification to products or to con- sions of the Agricultural Marketing tainers thereof. Act of 1946 (60 Stat. 1087; 7 U.S.C. 1621 (p) Inspected and certified or certified et seq.) or any other act of Congress means, with respect to any product, conferring like authority. that it has undergone an inspection (b) Acceptable means suitable for the and was found, at the time of such in- purpose intended and acceptable to the spection, to be sound, wholesome, and Service. fit for human food. (c) Administrator means the Adminis- (q) Inspection, inspection service, or in- trator of the Food Safety and Inspec- spection of products for condition and tion Service of the Department or any wholesomeness means any inspection by other officer or employee of the De- an inspector to determine, in accord- partment to whom there has heretofore ance with the regulations in this part, been delegated, or to whom there may (1) the condition and wholesomeness of hereafter be delegated the authority to rabbits, or (2) the condition and whole- act in his stead. someness of any edible product at any (d) Applicant means any interested state of the preparation or packaging party who requests any inspection thereof in the official plant where in- service. spected and certified, or (3) the condi- (e) Area supervisor means any em- tion and wholesomeness of any pre- ployee of the Department in charge of viously inspected and certified product rabbit inspection service in a des- if such product has not lost its identity ignated geographical area. as an inspected and certified product. (f) Carcass means any rabbit carcass. (r) Inspection certificate means a (g) Circuit supervisor or technical su- statement, either written or printed, pervisor means the officer in charge of issued by an inspector, pursuant to the the rabbit inspection service in a cir- regulations in this part, relative to the cuit consisting of a group of stations condition and wholesomeness of prod- within an area. ucts. (h) Class means any subdivision of a (s) Inspector means any person who is product based on essential physical licensed by the Secretary to inves- characteristics that differentiate be- tigate and certify, in accordance with tween major groups of the same kind. the regulations in this part, the condi- (i) Condition means any condition, in- tion and wholesomeness of products. cluding, but not being limited to, the An inspector is an employee of the De- state of preservation, cleanliness, or partment or of a State; he may be a soundness, of any product or the proc- graduate veterinarian or a layman.

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(t) Interested party means any person (ee) Service means the Food Safety financially interested in a transaction and Inspection Service of the Depart- involving any inspection. ment. (u) National supervisor means (1) the (ff) Station supervisor means any au- officer in charge of the rabbit inspec- thorized individual who is designated tion service of the Food Safety and In- to supervise rabbit inspection service spection Service, and (2) other officers in a large official plant or in a group of or employees of the Department des- several small plants. ignated by the officer in charge of the rabbit inspection service of the Food § 354.2 Designation of official certifi- Safety and Inspection Service. cates, memoranda, marks, other identifications, and devices for pur- (v) Official plant means one or more poses of the Agricultural Marketing buildings or parts thereof, comprising a Act. single plant in which the facilities and Subsection 203(h) of the Agricultural methods of operation therein have been Marketing Act of 1946, as amended by approved by the Administrator as suit- Pub. L. 272, 84th Congress, provides able and adequate for operation under criminal penalties for various specified inspection service and in which inspec- offenses relating to official certifi- tion is carried on in accordance with cates, memoranda, marks or other the regulations in this part. identifications, and devices for making (w) Person means any individual, such marks or identifications, issued or partnership, association, business authorized under section 203 of said trust, corporation, or any organized Act, and certain misrepresentations group of persons, whether incorporated concerning the inspection of agricul- or not. tural products under said section. For (x) Potable water means water that the purposes of said subsection and the has been approved by the State health provisions in this part, the terms listed authority as safe for drinking and suit- in this section shall have the respec- able for food processing. tive meanings specified: (y) Product means ready-to-cook (a) Official certificate means any form cooked rabbits, or edible products de- of certification, either written or print- rived therefrom. ed, used under this part to certify with (z) Rabbit means any domesticated respect to the inspection or class or rabbit, whether live or dead. condition of products. (aa) Rabbit inspection service means (b) Official memorandum means any the personnel who are engaged in the initial record of findings made by an administration, application, and direc- authorized person in the process of in- tion of rabbit inspection programs and specting or sampling, pursuant to this services pursuant to the regulations in part, any processing or plant operation this part. report made by an authorized person in (bb) Ready-to-cook domestic rabbit connection with inspecting or sampling means any rabbit which has been under this part, and any report made slaughtered for human food, from by an authorized person of services per- which the head, blood, skin, feet, and formed pursuant to this part. inedible viscera have been removed, (c) Official mark means the inspection that is ready to cook without need of mark, and any other mark, or any vari- further processing. Ready-to-cook rab- ations in such marks, approved by the bit also means any cut-up or disjointed Administrator and authorized to be af- portion of rabbit or any edible part fixed to any product, or affixed to or thereof, as described in this paragraph. printed on the packaging material of (cc) Regulations means the provisions any product, stating that the product of this entire part as may be in effect was inspected, or indicating the condi- at the time inspection is performed. tion of the product, or for the purpose (dd) Secretary means the Secretary of of maintaining the identity of products the Department, or any other officer or inspected under this part, including, employee of the Department to whom but not limited to, that set forth in there has heretofore been delegated, or § 354.65. to whom there may hereafter be dele- (d) Official identification means any gated, the authority to act in his stead. symbol, stamp, label, or seal indicating

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that the product has been officially in- § 354.13 Supervision. spected and/or indicating the class or All inspection service shall be sub- condition of the product approved by ject to supervision at all times by the the Administrator and authorized to be station supervisor, circuit supervisor, affixed to any product, or affixed to or area supervisor, and national super- printed on the packaging material of visor. Such service shall be rendered any product. where the facilities and conditions are (e) Official device means a stamping satisfactory for the conduct of the appliance, branding device, stencil, service and the requisite inspectors are printed label, or any other mechani- available. cally or manually operated tool that is approved by the Administrator for the § 354.14 Authority to waive provisions purpose of applying any official mark of § 354.12. or other identification to any product or the packaging material thereof. The Administrator is authorized to waive the provisions of § 354.12 which ADMINISTRATION pertain to the entry of uninspected edible products into official plants in spe- § 354.3 Administration. cific instances where rabbits are to be The Administrator shall perform, for brought into compliance with a law and under the supervision of the Sec- under the provisions of a court order. retary, such duties as are prescribed in Such rabbits shall be handled in an of- the regulations in this part and as the ficial plant in accordance with such Secretary may require in the adminis- procedures as the Administrator may tration of the regulations in this part. prescribe to insure proper segregation The Administrator is authorized to and identity of the rabbits or rabbit waive for limited periods any particu- products until they are shipped from lar provisions of the regulations to per- the official plant. mit experimentation so that new procedures, equipment, and processing PERFORMANCE OF SERVICES techniques may be tested to facilitate definite improvements and, at the § 354.20 Licensed or authorized inspectors. same time, to assure full compliance with the spirit and intent of the regu- (a) Any person who is a Federal or lations. The Food Safety and Inspec- State employee or the employee of a tion Service and its officers and em- local jurisdiction possessing proper ployees shall not be liable in damages qualifications as determined by an ex- through acts of commission or omis- amination for competency, and who is sion in the administration of this part. to perform inspection service under this part may be licensed or otherwise BASIS OF SERVICE authorized by the Secretary as an inspector. § 354.10 Inspection service. (b) All licenses issued by the Sec- Any inspection service in accordance retary shall be countersigned by the of- with the regulations in this part shall ficer in charge of the rabbit inspection be for condition and wholesomeness. service of the Animal and Plant Health Inspection Service or any other des- § 354.12 Eligibility. ignated officer of such Service. (a) Only rabbits which are processed in official plants in accordance with § 354.21 Suspension of license; revoca- the regulations in this part may be in- tion. spected. Pending final action by the Sec- (b) All rabbits that are eviscerated in retary, any person authorized to coun- an official plant where inspection serv- tersign a license to perform inspection ice is maintained shall be inspected for service may, whenever he deems such condition and wholesomeness and no action necessary to assure that any in- dressed rabbits or uninspected products spection service is properly performed, shall be brought into such official suspend any license to perform inspec- plant. tion service issued pursuant to this

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part, by giving notice of such suspen- pointees and revocation of licenses in sion to the respective licensee, accom- the case of licensees. panied by a statement of the reasons therefor. Within 7 days after the re- § 354.26 Schedule of operation of offi- ceipt of the aforesaid notice and state- cial plants. ment of reasons, the licensee may file Inspection operating schedules for an appeal in writing, with the Sec- services performed pursuant to § 354.107 retary, supported by any argument or shall be requested in writing and be ap- evidence that he may wish to offer as proved by the Administrator. Normal to why his license should not be fur- operating schedules for a full week ther suspended or revoked. After the consist of a continuous 8-hour period expiration of the aforesaid 7–day period per day (excluding not to exceed 1 hour and consideration of such argument for lunch), 5 consecutive days per week, and evidence, the Secretary will take within the period of Monday through such action as he deems appropriate Saturday, for each shift required. Less with respect to such suspension or rev- than 8-hour schedules may be re- ocation. When no appeal is filed within quested and will be approved if an in- the prescribed 7 days, the license to spector is available. Sundays may not perform inspection service is revoked. be approved in any tour of duty. Clock hours of daily operations need not be § 354.22 Surrender of license. specified in the request, although as a Each license which is suspended, or condition of continued approval, the revoked, or has expired shall promptly hours of operation shall be reasonably be surrendered by the licensee to his uniform from day to day. Inspectors immediate superior. Upon termination are to be notified by management 1 day of the services of a licensed inspector, in advance of any change in the hours the licensee shall promptly surrender inspection service is requested. his license to his immediate superior. APPLICATION FOR INSPECTION SERVICE § 354.23 Identification. § 354.30 Who may obtain inspection Each inspector shall have in his pos- service. session at all times, and present upon An application for inspection service request while on duty, the means of may be made by any interested person, identification furnished by the Depart- including, but not being limited to, the ment to such person. United States, any State, county, mu- § 354.24 Financial interest of inspec- nicipality, or common carrier, and any tors. authorized agent of the foregoing. No inspector shall render service on § 354.31 How application for service any product in which he is financially may be made; conditions of resident interested. service. (a) On a fee basis. An application for § 354.25 Political activity. any inspection service on a fee basis All inspectors are forbidden, during may be made in any office of inspec- the period of their respective appoint- tion or with any inspector at or nearest ments or licenses, to take an active the place where the service is desired. part in political management or in po- Such application may be made orally litical campaigns. Political activity in (in person or by telephone), in writing, city, county, State, or national elec- or by telegraph. If the application for tions, whether primary or regular, or inspection service is made orally, the in behalf of any party or candidate, or office of inspection or the inspector any measure to be voted upon, is pro- with whom the application is made, or hibited. This applies to all appointees, the Administrator, may require that including, but not being limited to, the application be confirmed in writ- temporary and cooperative employees ing. and employees on leave of absence with (b) On a resident inspection basis. An or without pay. Willful violation of application for resident inspection §§ 354.20 to 354.25 will constitute service must be made in writing on grounds for dismissal in the case of ap- forms approved by the Administrator

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and filed with the Administrator. Such to scale, and shall consist of floor plans forms may be obtained at the national, and a plot plan. area, or State inspection office. In (2) The plot plan shall show such fea- making application, the applicant tures as the limits of the plant’s prem- agrees to comply with the terms and ises, locations in outline of buildings conditions of the regulations (includ- on the premises, one point of the coming, but not being limited to, such in- pass, and roadways and railroads serv- structions governing inspection of ing the plant. products as may be issued from time to (3) The floor plan shall show all space time by the Administrator). No mem- to be included in the official plant. If ber of or delegate to Congress or Resi- rooms or compartments shown on the dent Commissioner shall be admitted drawings or blueprints are not to be in- to any benefit that may arise from cluded as part of the official plant, this such service unless derived through shall be clearly indicated thereon. service rendered a corporation for its (4) The sheets of paper on which general benefit. drawings or blueprints are made shall not exceed a size 34′′ x 44′′. The draw- § 354.32 Filing of application. ings other than of the plot plan shall An application for inspection service be made to a scale of 1⁄8′′ per foot, ex- shall be regarded as filed only when cept that additional plans for some made pursuant to the regulations in areas showing detail may be drawn to a this part. scale of 1⁄4′′ per foot. The plot plan may be drawn to a scale of not less than 1⁄32′′ § 354.33 Authority of applicant. per foot. The drawings shall indicate Proof of the authority of any person the scale used and shall also indicate applying for inspection service may be the floor shown (e.g., basement, first, required at the discretion of the Ad- or second). ministrator. (c) Features required to be shown on floor plan. The following features shall § 354.34 Application for inspection be shown on the floor plan: service in official plants; approval. (1) The principal pieces of equipment Any person desiring to process and drawn to scale in the proper locations. pack products in a plant under inspec- (2) The name of the firm and the ad- tion service must receive approval of dress of the plant by street and street such plant and facilities as an official number, or by other means properly plant prior to the rendition of such identifying the location of the plant. service. An application for inspection (3) One point of the compass. service to be rendered in an official (4) The doors and openings for pas- plant shall be approved according to sageways, designating those which are the following procedure: self-closing or permanently closed. (a) Initial survey. When application (5) All floor drain openings and gut- has been filed for inspection service as ter drains. aforesaid, the area supervisor, or his (6) Lavatories in toilet and process- assistant, shall examine the plant, ing rooms (lavatories which are other premises, and facilities and shall speci- than hand-operated shall be so des- fy any additional facilities required for ignated on the drawings or blueprints). the service. Appeals with respect to (7) All steam and hot and cold water any such specification may be made to outlets for cleanup purposes. the national supervisor. (8) Ice-making and storage facilities. (b) Drawings and specifications to be (9) The point at which live rabbits furnished in advance of construction or are hung on the conveyor line, the alterations. point at which the ready-to-cook rab- (1) Four copies of drawings or blue- bits are removed, and any intermediate prints showing the features specified transfer points. herein shall be submitted to the Ad- (10) The routes of the edible and ined- ministrator. The drawings or blue- ible products. prints shall be legible, made with (11) The location of fresh air inlets, sharp, clear lines, and properly drawn exhaust fans, and hoods.

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(d) Specifications. Specifications cov- spection will be handled or kept. It also ering the following items shall accom- may include other rooms or compart- pany the drawings: ments located in the buildings com- (1) Height of ceilings. prising the official plant. (2) Type of ceilings—open or closed. (f) Changes in drawings or blueprints. (3) Finish of ceilings; for example— When changes are proposed in areas for cement plaster, metal, marine ply- which drawings or blueprints have been wood, cement, asbestos board, etc. previously approved, one of the follow- (4) Finish of walls; for example—ce- ing types of revised drawings or blue- ment plaster, glazed tile, glaze brick, prints shall be submitted for review glass blocks, etc. and consideration. (5) Screens—indicate whether all out- (1) A completely revised sheet or side openings are screened or provided sheets showing proposed alterations or with other suitable devices against en- additions, or trance of flies or other insects. (2) Approved pasters of the proposed (6) Finish of floors—concrete, brick, changes which may be affixed to the af- mastic material, etc. fected areas on the previously approved (7) Drainage—indicate the amount of drawings or blueprints in a manner not slope of floors to the drains in process- obscuring essential data. Paster drawing rooms, coolers, toilets, and refuse ings and blueprints shall be prepared to rooms, and give description of trapping the same scale and presented on a and venting of drainage lines and of background similar to that of the floor drain openings. Indicate size of originally approved drawing or blue- drainage lines and whether house print. drainage lines and toilet soil lines are (g) Final survey and plant approval. separate to a point outside of build- Prior to the inauguration of the inspec- ings. tion service, a final survey of the plant (8) Heating—indicate type. and premises shall be made by the area (9) Water supply—indicate whether supervisor or his assistant to deter- public or private water supply, or both, mine if the plant is constructed and fa- and specify in terms of gallons of water cilities are installed in accordance available per minute for the processing with the approved drawings and the needs of the plant. Also indicate regulations in this part. The plant may whether or not a nonpotable water sup- be approved by the Administrator only ply is used for any purpose in the plant when these requirements have been and, if so, specify such uses. met, except that conditional approval (10) Hot water facilities—specify fa- for a specified limited time may be cilities such as boilers, storage tanks, granted only under emergency condi- mixing valves, etc., and indicate the tions of restricted availability of facili- size and number of boilers and storage ties and construction materials, pro- tanks. vided practices suitable to the Admin- (11) Specify number of men and num- istrator are employed to effect ade- ber of women who will use each toilet quate sanitary conditions in the plant. room. (12) Sewage disposal—indicate wheth- (Approved by the Office of Management and er city sewer, cesspool, sedimentation Budget under control number 0583–0036) tank, etc. [41 FR 23702, June 11, 1976, as amended at 47 (13) Approximate rate of production— FR 746, Jan. 7, 1982] indicate hourly rate of slaughter and § 354.35 Rejection of application. evisceration for rabbits. (e) Rooms and compartments which Any application for inspection serv- must be included in the official plant. ice may be rejected by the Adminis- The official plant shall include employ- trator: ees’ toilet and dressing rooms, office (a) Whenever the applicant fails to space for the inspectors, storerooms for meet the requirements of the regula- supplies, refuse rooms, and rooms, tions prescribing the conditions under compartments, or passageways where which the service is made available; rabbits or any ingredients to be used in (b) Whenever the product is owned by the preparation of products under in- or located on the premises of a person

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currently denied the benefits of the (1) Failure to maintain plant and Act; equipment in a satisfactory state of re- (c) Where any individual holding of- pair; fice or a responsible position with or (2) The use of operating procedures having a substantial financial interest which are not in accordance with the or share in the applicant is currently regulations in this part; or denied the benefits of the Act or was (3) Alterations of buildings, facilities, responsible in whole or in part for the or equipment which cannot be ap- current denial of the benefits of the proved in accordance with the regula- Act to any person; tions in this part. (d) Where the Administrator deter- (b) During such period of suspension, mines that the application is an at- inspection service shall not be ren- tempt on the part of a person currently dered. However, the other provisions of denied the benefits of the Act to obtain the regulations pertaining to providing inspection service; service on a resident basis will remain (e) Whenever the applicant, after an in effect unless such service is termi- initial survey has been made in accord- nated in accordance with the provi- ance with § 354.34(a), fails to bring the sions of this part. If the plant facilities plant, facilities, and operating proce- or methods of operation are not dures into compliance with the regula- brought into compliance within a rea- tions within a reasonable period of sonable period of time, to be specified time; or by the Administrator, the service shall (f) Notwithstanding any prior ap- be terminated. Upon termination of in- proval whenever, before inauguration spection service in an official plant of service, the applicant fails to fulfill pursuant to the regulations in this commitments concerning the inau- part, the plant approval shall also be- guration of the service. Each such ap- come terminated, and all labels, seals, plicant shall be promptly notified by tags or packaging material bearing of- registered mail of the reasons for the ficial identification shall, under the su- rejection. A written petition for recon- pervision of a person designated by the sideration of such rejection may be Service, either be destroyed, or the of- filed by the applicant with the Admin- ficial identification completely obliter- istrator if postmarked or delivered ated, or sealed in a manner acceptable within 10 days after the receipt of no- to the Service. tice of the rejection. Such petition VIOLATIONS shall state specifically the errors alleged to have been made by the Admin- § 354.45 Denial of service. istrator in rejecting the application. Within 20 days following the receipt of (a) The acts or practices set forth in such a petition for reconsideration, the §§ 354.46 through 354.51 or the causing Administrator shall approve the appli- thereof may be deemed sufficient cation or notify the applicant by reg- cause, for the debarment, by the Sec- istered mail of the reasons for the re- retary, of any person, including any jection thereof. agents, officers, subsidiaries, or affiliates of such person, from any or all § 354.36 Withdrawal of application. benefits of the Act for a specified period after notice and opportunity for Any application for inspection serv- hearing has been afforded. ice may be withdrawn by the applicant (b) Whenever the Administrator has at any time before the service is per- reason to believe that any person or his formed upon payment, by the appli- employee, agent, or representative has cant, of all expenses incurred by the flagrantly or repeatedly committed Service in connection with such appli- any of the acts or practices specified in cation. §§ 354.46 to 354.51, he may, without hearing, direct that the benefits of the Act § 354.38 Suspension of plant approval. be denied such person, including any (a) Any plant approval given pursu- agents, officers, subsidiaries, or affili- ant to the regulations in this part may ates of such person, pending investiga- be suspended by the Administrator for: tion and hearing, and shall give notice

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thereof to any such person in the man- § 354.49 Interfering with an inspector ner prescribed in § 1.147(b) of the rules or employee of Service. of practice (7 CFR 1.147(b)). The Admin- Any interference with or obstruction istrator’s decision to deny the benefits or any attempted interference or ob- of the Act to any such person, includ- struction of or assault upon any in- ing any agents, officers, subsidiaries, spector or employee of the Service in or affiliates of such person, shall be ef- the performance of his duties. The giv- fective upon service of such notice. A ing or offering directly or indirectly of written petition for reconsideration of any money, loan, gift, or anything of such interim denial may be filed with value to an employee of the Service or the Administrator by any person so de- the making or offering of any contribu- nied the benefits of the Act within 10 tion to or in any way supplementing days after notice of the interim denial. the salary, compensation, or expenses Such petition shall state specifically of an employee of the Service, or the the errors alleged to have been made offering or entering into a private con- by the Administrator in denying the tract or agreement with an employee benefits of the Act pending investiga- of the Service for any services to be tion and hearing. Within 20 days fol- rendered while employed by the Serv- lowing the receipt of such petition for ice. reconsideration, the Administrator shall reinstate the benefits of the Act § 354.51 Miscellaneous. or notify the petitioner of the reasons for continued interim denial. The existence of any of the conditions set forth in § 354.35 constituting a [41 FR 23702, June 11, 1976, as amended at 43 basis for the rejection of an application FR 11148, Mar. 17, 1978] for inspection service. § 354.46 Misrepresentation; deceptive OTHER APPLICABLE REGULATIONS or fraudulent acts or practices. Any willful misrepresentation or any § 354.53 Other applicable regulations. deceptive or fraudulent act or practice Compliance with the regulations in made or committed by any person in this part shall not excuse failure to connection with: comply with any other Federal or any (a) The making or filing of any appli- State or municipal applicable laws or cation for any inspection service; regulations. (b) The making of the product accessible for inspection; IDENTIFYING AND MARKING PRODUCTS (c) The making, issuing, or using, or attempting to issue or use any inspec- § 354.60 Approval of official identification certificate, symbol, stamp, label, tion. seal or identification, authorized pur- (a) Any label or packaging material suant to the regulations in this part; which bears any official identification (d) The use of the terms ‘‘U.S. In- shall be used only in such manner as spected’’ or ‘‘Government Inspected’’, the Administrator may prescribe. No or any term of similar import in the la- label or packaging material bearing of- beling or advertising of any product. ficial identification may be used unless finished copies or samples of such la- § 354.47 Use of facsimile forms. bels and packaging material have been Using or attempting to use a form approved by the Administrator. No which simulates, in whole or in part, label bearing official identification any certificate, symbol, stamp, label, shall be printed for use until the print- seal or identification authorized to be er’s final proof has been approved by issued or used under the regulations in the Administrator, and no label, other this part. than labels for shipping containers or containers for institutional packs, § 354.48 Willful violation of the regula- bearing any official identification shall tions. be used until finished copies or samples Any willful violation of the regula- of such labels have been approved by tions in this part or the Act. the Administrator. Final approval may

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be given to printer’s final proof or pho- and the name of the packer or distribu- tostatic copies of labels for shipping tor of such product shall be printed on containers or containers for institu- the packaging material or label, as the tional packs, and no such labels shall case may be, except that on shipping be used until such proofs or copies have containers and containers for institu- been approved by the Administrator. A tional packs, the inspection marks label which bears official identification may be stenciled on the container and, shall not bear any statement that is when the inspection mark is so sten- false or misleading, and if labels in the ciled, the name and address of the name of the same packer or distribu- packer or distributor may be applied tor, or bearing the same brand name, by the use of a stencil or a rubber are used on the same or similar prod- stamp. Notwithstanding the foregoing, ucts which are prepared from products the name and address of the packer or which are not inspected, the diameter of the inspection mark used on labels distributor, if appropriately shown for inspected products shall be equal to elsewhere on the packaging material, at least one-tenth of the length of the may be omitted from insert labels label, plus at least one-tenth of the which bear an official identification if width of the label. If the labeling is the applicable plant number is shown. printed or otherwise applied directly to (b) Wording on labels. Each trade label the container, the principal display to be approved for use pursuant to panel of such container shall, for this §§ 354.60 to 354.64 with respect to any in- purpose, be considered as the label. spected and certified edible product shall bear the true name of the edible § 354.62 Inspection mark with respect product, the name and address of the to product. packer or distributor thereof, and in The Administrator is authorized to prominent letters and figures of uni- prescribe and approve the form of the form size, the inspection mark, as inspection mark that may be used. aforesaid, and the label shall also bear, in such manner as may be prescribed or § 354.63 Marking inspected products. approved by the Administrator, the (a) Wording and form of inspection plant number, if any, of the official mark. Except as otherwise authorized, plant in which such product was in- the inspection mark permitted to be spected and certified. The class of the used with respect to inspected and cer- rabbits shall be shown on the label. tified edible products shall include The appropriate designation ‘‘young’’, wording as follows: ‘‘Inspected for Wholesomeness by U.S. Department of ‘‘mature’’, or ‘‘old’’ may be used as a Agriculture.’’ This wording shall be prefix to the word ‘‘rabbit’’ in lieu of contained within a circle in the form the class name. and arrangement shown in § 354.65. The (c) Labels in foreign languages. Any appropriate plant number of the offi- trade label to be affixed to a container cial plant shall be included in the cir- of any edible products for foreign com- cle unless it appears elsewhere on the merce may be printed in a foreign lan- packaging material. The Adminis- guage. However, the inspection mark trator may approve the use of abbre- shall appear on the label in English, viations of such inspection mark, and but, in addition, may be literally trans- such approved abbreviations shall have lated into such foreign language. Each the same force and effect as the inspec- such trade label which is to be printed tion mark. The inspection mark or ap- in a foreign language must be approved proved abbreviation thereof, as the pursuant to §§ 354.60 to 354.64. case may be, may be applied to the in- (d) Unauthorized use or disposition of spected and certified edible product or approved labels. (1) Labels approved for to the packaging material of such prod- use pursuant to §§ 354.60 to 354.64 shall uct. When the inspection mark, or the be used only for the purpose for which approved abbreviation thereof, is used approved and shall not otherwise be on packaging material, it shall be disposed of from the plant for which printed on such material or on a label to be affixed to the packaging material approved except with written approval

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of the Administrator. Any unauthor- SUPERVISION OF MARKING AND ized use or disposition of approved la- PACKAGING bels or labels bearing official identification may result in cancellation of § 354.70 Evidence of label approval. the approval and denial of the use of la- No inspector shall authorize the use bels bearing official identification or of official identification for any in- denial of the benefits of the Act pursu- spected product unless he has on file ant to the provisions of § 354.60. evidence that such official identifica- (2) The use of simulations or imitation or packaging material bearing tions of any official identification by such official identification has been ap- any person is prohibited. proved in accordance with the provi- (e) Rescindment of approved labels. sions of §§ 354.60 to 354.64. Once a year, or more often if requested, each applicant shall submit to the Ad- § 354.71 Affixing of official identifica- ministrator a list in triplicate of ap- tion. proved labels that have become obso- (a) No official identification or any lete, accompanied with a statement abbreviation, copy, or representation that such approvals are no longer de- thereof may be affixed to or placed on sired. The approvals shall be identified or caused to be affixed to or placed on by the date of approval and the name any product or container thereof ex- of product or other designation show- cept by an inspector or under the su- ing the class of material. pervision of an inspector. All such products shall have been inspected and § 354.64 Form of official identification. certified. The inspector shall have su- The form prescribed in § 354.65 is sub- pervision over the use and handling of ject to the requirements of §§ 354.60 to all material bearing any official identi- 354.64, Identifying and Marking Prod- fication. ucts. (b) Each container of inspected and certified products to be shipped from § 354.65 Form of inspection mark. one official plant to another official plant for further processing shall be The inspection mark approved for use marked for identification and shall on inspected and certified edible prod- show the following information: ucts shall be contained within a circle and include the following wording: ‘‘In- (1) The name of the inspected and spected for Wholesomeness by U.S. De- certified products in the container; partment of Agriculture.’’ The form (2) The name and address of the pack- and arrangement of such wording shall er or distributor of such products; be as indicated in the example below. (3) The net weight of the container; The plant number of the official plant (4) The inspection mark permitted to shall be set forth if it does not appear be used pursuant to the regulations in on the packaging material. this part unless the containers are sealed or otherwise identified in such manner as may be approved by the Ad- ministrator; and (5) The plant number of the official plant where the products were packed.

§ 354.72 Packaging. No container which bears or may bear any official identification or any abbreviation or copy or representation thereof may be filled in whole or in part except with edible products which were inspected and certified and are, at the time of such filing, sound, wholesome, and fit for human food. All such filling of containers shall be under the supervision of an inspector.

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§ 354.73 Retention labels. § 354.92 Reports of violation. An inspector may use such labels, de- Each inspector shall report, in the vices, and methods as may be approved manner prescribed by the Adminis- by the Administrator for the identi- trator, all violations of and noncompli- fication of: ance with the Act and the regulations (a) Products which are held for fur- in this part of which he has knowledge. ther examination, and FEES AND CHARGES (b) All equipment and utensils which are to be held for proper cleaning. § 354.100 Payment of fees and charges. § 354.74 Prerequisites to inspection. (a) Fees and charges for any inspection shall be paid by the applicant for Inspection of products shall be ren- the service in accordance with the ap- dered pursuant to the regulations in plicable provisions of §§ 354.100 to this part and under such conditions and 354.110, both inclusive. If so required by in accordance with such methods as the inspector, such fees and charges may be prescribed or approved by the shall be paid in advance. Administrator. (b) Fees and charges for any inspection service shall, unless otherwise re- § 354.75 Accessibility of products. quired pursuant to paragraph (c) of this Each product for which inspection section, be paid by check, draft, or service is requested shall be so ar- money order payable to the Food Safe- ranged so as to permit adequate deter- ty and Inspection Service and remitted mination of its class, quantity, and promptly to the Service. condition as the circumstances may (c) Fees and charges for any inspec- warrant. tion pursuant to a cooperative agreement with any State or person shall be § 354.76 Time of inspection in an offi- paid in accordance with the terms of cial plant. such cooperative agreement. The inspector who is to perform the § 354.101 On a fee basis. inspection in an official plant shall be informed, in advance, by the applicant (a) Unless otherwise provided in this of the hours when such inspection is part, the fees to be charged and col- desired. Inspectors shall have access at lected for any service performed, in ac- all times to every part of any official cordance with this part, on a fee basis plant to which they are assigned. shall be based on the applicable rates specified in this section. REPORTS (b) The charges for inspection service will be based on the time required to § 354.90 Report of inspection work. perform such services. The hourly rates shall be as specified in §§ 391.2 and 391.3 Reports of the work of inspection respectively for base time and for over- carried on within official plants shall time or holiday work. be forwarded to the Administrator by (c) Charges for certain laboratory the inspector in such manner as may analysis or laboratory examination of be specified by the Administrator. rabbits under this Part related to in- § 354.91 Information to be furnished to spection service shall be at the rate inspectors. specified in § 391.4 for that part which is not covered under the base time, over- When inspection service is performed time, and/or holiday costs. within an official plant, the applicant for such inspection shall furnish to the [41 FR 23702, June 11, 1976, as amended at 53 inspector rendering such service such FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 1989] information as may be required for the purposes of §§ 354.90 to 354.92. § 354.105 Fees for additional copies of (Approved by the Office of Management and inspection certificates. Budget under control number 0583–0036) Additional copies, other than those [41 FR 23702, June 11, 1976, as amended at 47 provided for in §§ 354.141, 354.142, and FR 746, Jan. 7, 1982] 354.143, of any inspection certificates

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may be supplied to any interested INSPECTION PROCEDURES; ANTE-MORTEM party upon payment of a fee of $2.00 for INSPECTIONS each set of five or fewer copies. § 354.120 Manner of handling products § 354.106 Travel expenses and other in an official plant. charges. Unless otherwise specified in the reg- Charges are to be made to cover the ulations in this part or by the Adminis- cost of travel and other expenses in- trator, products which are to be further processed under inspection in an curred by the Service in connection official plant shall be prepared and with rendering inspection service. Such handled in such official plant under the charges shall include the costs of supervision of an inspector. transportation, per diem, and any other expenses. § 354.121 Ante-mortem inspection. An ante-mortem inspection of rabbits § 354.107 Continuous inspection per- shall, where and to the extent consid- formed on a resident basis. ered necessary by the Administrator The charges for inspection of rabbits and under such instructions as he may and products thereof shall be those pro- issue from time to time, be made of vided for in § 354.101(b) and specified by rabbits on the day of slaughter in any hourly rates in §§ 391.2 and 391.3 when official plant processing rabbits under the inspection service is performed on inspection pursuant to the regulations a continuous year-round resident basis in this part. and the services of an inspector or in- § 354.122 Condemnation on ante- spectors are required 4 or more hours mortem inspection. per day. When the services of an inspector are required on an intermittent Rabbits found in a dying condition on basis, the charges shall be those pro- premises of an official plant shall be immediately destroyed and, together vided for in § 354.101(b) and specified by with any rabbits found dead on such hourly rates in §§ 391.2 and 391.3 plus premises, shall be disposed of in ac- the travel expense and other charges cordance with § 354.132. Rabbits plainly provided for in § 354.106. showing, on ante-mortem inspection, [54 FR 6390, Feb. 10, 1989] any disease or condition, that under §§ 354.129 to 354.131, inclusive, would § 354.109 Fees or charges for inspec- cause condemnation of their carcasses tion service performed under coop- on post-mortem inspection, shall be erative agreement. condemned. Rabbits which, on ante- Fees or charges to be made to an ap- mortem inspection, are condemned plicant for any inspection service shall not be dressed, nor shall they be which differ from those listed in conveyed into any department of the §§ 354.100 through 354.107 shall be pro- plant where rabbit products are prepared or held. Rabbits which have been vided for by a cooperative agreement. condemned on ante-mortem inspection § 354.110 Disposition of fees for inspec- and have been killed shall, under the tion made under cooperative agree- supervision of an inspector of the In- ment. spection Service, receive treatment as provided in § 354.132. Fees for inspection under a cooperative agreement with any State or per- § 354.123 Segregation of suspects on son shall be disposed of in accordance ante-mortem inspection. with the terms of such agreement. All rabbits which, on ante-mortem Such portion of the fees collected inspection, do not plainly show, but are under a cooperative agreement as may suspected of being affected with any be due the United States shall be re- disease or condition that under mitted to the Service. §§ 354.129 to 354.131, inclusive, may

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cause condemnation in whole or in part diately after inspection as ready-to- on post-mortem inspection, shall be cook rabbit. segregated from the other rabbits and held for separate slaughter, eviscera- § 354.126 Carcasses held for further ex- tion, and post-mortem inspection. The amination. inspector shall be notified when such Each carcass, including all parts segregated lots are presented for post- thereof, in which there is any lesion of mortem inspection and inspection of disease or other condition, which such rabbits shall be conducted sepa- might render such carcass or any part rately. Such procedure for the correla- thereof unfit for human food, and with tion of ante-mortem and post-mortem respect to which a final decision can- findings by the inspector, as may be not be made on first examination by prescribed or approved by the Adminis- the inspector, shall be held for further trator, shall be carried out. examination. The identity of each such carcass, including all parts thereof, § 354.124 Quarantine of diseased rab- shall be maintained until a final exam- bits. ination has been completed. If live rabbits, which are affected by § 354.127 Condemnation and treatment any contagious disease which is trans- of carcasses. missible to man, are brought into an official establishment, such rabbits Each carcass, or any part thereof, shall be segregated. The slaughtering which is found to be unsound, unof such rabbits shall be deferred and wholesome, or otherwise unfit for they shall be dealt with in one of the human food shall be condemned by the following ways: inspector and shall receive such treatment, under the supervision of the in- (a) If it is determined by a veterinary spector, as will prevent its use for inspector that further handling of the human food and preclude dissemination rabbits will not create a health hazard, of disease through consumption by ani- the lot shall be subject to ante-mortem mals. and post-mortem inspection pursuant to the regulations in this part. § 354.128 Certification of carcasses. (b) If it is determined by a veterinary Each carcass and all parts and organs inspector that further handling of the thereof which are found by the inspec- rabbits will not create a health hazard, tor to be sound, wholesome, and fit for such rabbits may be released for treat- human food shall be certified as pro- ment under the control of an appro- vided in this part. priate State or Federal agency. If the circumstances are such that release for DISPOSITION OF DISEASED RABBIT treatment is impracticable, a careful CARCASSES AND PARTS rabbit-by-rabbit ante-mortem inspection shall be made, and all rabbits § 354.129 General. found to be, or which are suspected of The carcasses or parts of carcasses of being, affected with the contagious dis- all rabbits inspected at an official es- ease transmissible to man shall be con- tablishment and found at the time of demned. post-mortem inspection, or at any subsequent inspection, to be affected with POST-MORTEM INSPECTION any of the diseases or conditions named in other sections in this part, § 354.125 Evisceration. shall be disposed of in accordance with No viscera or any part thereof shall the section pertaining to the disease or be removed from any rabbits which are condition. Owing to the fact that it is to be processed under inspection in any impracticable to formulate rules for official plant, except at the time of each specific disease or condition and evisceration and inspection. Each car- to designate at just what stage a dis- cass to be eviscerated shall be opened ease process results in an unwholesome so as to expose the organs and the body product, the decision as to the disposal cavity for proper examination by the of all carcasses, parts, or organs not inspector and shall be prepared imme- specifically covered by the regulations,

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or by instructions of the Administrator meninges; septicemia or pyemia, issued pursuant thereto, shall be left to whether traumatic, or without evident the inspector in charge, and if the in- cause; gangrenous or severe hemor- spector in charge is in doubt concern- rhagic enteritis or gastritis; ing the disposition to be made, speci- polyarthritis and acute nephritis. Im- mens from such carcasses shall be for- mediately after the slaughter of any warded to the laboratory for diagnosis. rabbit so infected, the infected premises and implements used shall be thor- § 354.130 Diseases or conditions evi- oughly sanitized. The part or parts of dent which require condemnation. any carcass coming into contact with (a) Carcasses of rabbits affected with the carcass or any part of the carcass or showing lesions of any of the follow- of any rabbit covered by this section ing named diseases or conditions shall other than those affected with acute be condemned: Tularemia, anthrax, inflammation of the lungs, pleura, per- hemorrhagic septicemia, pyemia, septi- icardium, peritoneum or meninges, cemia, leukemia, acute enteritis, peri- shall be condemned. tonitis, sarcomatosis, metritis, (g) Carcasses showing any degree of necrobacillosis (Smorl’s Disease), tu- icterus with a parenchymatous degen- berculosis, emaciation, eration of organs, the result of infec- streptobacillary pseudotuberculosis, tion or intoxication, and those which, and advanced stages of snuffles. Rab- as a result of a pathological condition, bits from pathological laboratories show an intense yellow or greenish-yel- shall be condemned. low discoloration without evidence of (b) Any organ or part of a rabbit car- infection or intoxication shall be con- cass affected with a tumor shall be condemned. demned and when there is evidence (h) Carcasses of rabbits affected with that the general condition of the rabbit mange or scab in advanced stages, or has been affected by the size, position, showing emaciation or extension of the or nature of the tumor, the whole car- inflammation to the flesh, shall be con- cass shall be condemned. In cases of demned. When the diseased condition is malignant neoplasms involving any in- slight, the carcass may be passed for ternal organ to a marked extent, or af- food after removal and condemnation fecting the muscles, skeleton, or body of the affected parts. lymph glands, even primarily, the (i) In the disposal of carcasses and whole carcass shall be condemned. parts of carcasses showing evidence of (c) Carcasses of rabbits showing any infestation with parasites not trans- disease such as generalized melanosis, missible to man, the following general pseudoleukemia, and the like, which rules shall govern: If the lesions are lo- systemically affect the rabbit, shall be calized in such manner and are of such condemned. character that the parasites and the le- (d) Any organ or part of a carcass sions caused by them may be radically which is badly bruised or which is af- removed, the non-affected portion of fected by an abscess, or a suppurating the carcass, or part of the carcass, may sore, shall be condemned. Parts or car- be certified for food after the removal casses which are contaminated by pus and condemnation of the affected por- shall be condemned. tions. Where a part of a carcass shows (e) Carcasses of rabbits contaminated numerous lesions caused by parasites, by volatile oils, paints, poisons, gases, or the character of the infestation is or other substances which affect the such that complete extirpation of the wholesomeness of the carcass shall be parasites and lesions is difficult and condemned. uncertainly accomplished, or if the (f) All carcasses of rabbits so infected parasitic infestation or invasion ren- that consumption of the meat or meat ders the organ or part in any way unfit food products thereof may give rise to for food, the affected organ or part meat poisoning shall be condemned. shall be condemned. Where parasites This includes all carcasses showing are found to be distributed in a carcass signs of any of the following diseases: in such a manner or to be of such a Acute inflammation of the lungs, pleu- character that their removal and the ra, pericardium, peritoneum or removal of the lesions caused by them

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are impracticable, no part of the car- (b) Incineration or complete destruc- cass shall be certified for food and the tion by burning. entire carcass shall be condemned. Car- (c) Chemical denaturing, which shall casses infested with a hydatid cyst or be accomplished by the liberal applica- cysts (Echinococcus granulosis), trans- tion to all carcasses and parts thereof, missible to dogs and from dogs to man, of: shall in all cases be condemned regard- (1) Crude carbolic acid, less of the degree of infestation. (2) Kerosene, fuel oil, or used crank (j) Carcasses of rabbits showing such case oil, degree of emaciation or anemic condi- (3) Any phenolic disinfectant con- tion as would render the meat un- forming to commercial standards CS wholesome, and carcasses which show a 70–41 or CS 71–41 which shall be used in slimy degeneration of the fat or a seri- at least 2 percent emulsion or solution, ous infiltration of the muscles shall be or condemned. (4) Any other substance that the Ad- ministrator approves which will § 354.131 Decomposition. decharacterize the carcasses or parts to Carcasses of rabbits deleteriously af- the extent necessary to accomplish the fected by post-mortem changes shall be purposes of this section. disposed of as follows: (a) Carcasses which have reached a REINSPECTION AND INGREDIENTS state of putrefaction or stinking fermentation shall be condemned. § 354.133 Reinspection of edible prod- (b) [Reserved] ucts; ingredients. (c) Carcasses affected by types of (a) Any inspected and certified edible post-mortem change which are super- product may be brought into an official ficial in nature may be certified for plant only if the container of such food after removal and condemnation product is marked for identification in of affected parts. the manner prescribed in § 354.71(b) and the product is reinspected by an inspec- § 354.132 Disposal of condemned car- tor at the time it is brought into such casses and parts. plant. Upon reinspection, if any such All condemned carcasses, or parts of product or portion thereof is found to carcasses, shall be disposed of by one of be unsound, unwholesome, or otherwise the following methods, under the su- unfit for human food, such product, or pervision of an inspector of the Inspec- portion thereof, shall be condemned tion Service: (Facilities and materials and shall receive treatment as provided for carrying out the requirements in in § 354.127. this section shall be furnished by the (b) Any product which is prepared official establishment.) under inspection in an official plant (a) Steam treatment (which shall be shall be inspected in such plant as accomplished by processing the con- often as the inspector deems it nec- demned product in a pressure tank essary in order to ascertain whether under at least 40 pounds of steam pres- such product is sound, wholesome, and sure) or thorough cooking in a kettle fit for human food at the time such or vat for a sufficient time to effec- product leaves such plant. Upon any tively destroy the product for human such inspection, if any such product or food purposes and preclude dissemina- portion thereof is found to be unsound, tion of disease through consumption by unwholesome, or otherwise unfit for animals. Tanks and equipment used for human food, such product or portion this purpose or for rendering or prepar- thereof shall be condemned and shall ing inedible products shall be in rooms receive treatment as provided in or compartments separate from those § 354.127. used for the preparation of edible prod- (c) All substances and ingredients ucts. There shall be no direct connec- used in the manufacture or preparation tion, by means of pipes or otherwise, of any edible product shall be clean, between tanks containing inedible sound, wholesome, and fit for human products and those containing edible food. Liquid and frozen egg products products. used in the preparation of any edible

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product shall have been prepared under products and the total net weight continuous inspection of the Depart- thereof. ment. § 354.141 Issuance and disposition of APPEALS rabbits inspection certificates. (a) Upon the request of an interested § 354.134 Appeal inspections; how made. party, any inspector is authorized to issue a rabbit inspection certificate Any person receiving inspection serv- with respect to any lot of rabbits in- ice may, if dissatisfied with any deci- spected by him. Each certificate shall sion of an inspector relating to any in- be signed by the inspector who made spection, file an appeal from such deci- the inspection covered by the certifi- sion: Provided, That such appeal is filed cate, and if more than one inspector within 48 hours from the time the decision was made. Any such appeal from a participated in the inspection of the lot decision of an inspector shall be made of rabbits, each such inspector shall to his immediate superior having juris- sign the certificate with respect to diction over the subject matter of the such lot. appeal. Review of such appeal findings, (b) The original and a copy of each when requested, shall be made by the inspection certificate, issued pursuant immediate superior of the employee of to §§ 354.140 to 354.144, and not to exceed the Department making the appeal in- two additional copies thereof if re- spection. The cost of any such appeal quested by the applicant prior to issu- shall be borne by the applicant if the ance, shall, immediately upon issu- Administrator determines that the ap- ance, be delivered or mailed to the appeal is frivolous. The charges for such plicant or person designated by him. frivolous appeal shall be based on the One copy shall be filed in the office of hourly rates as specified in § 354.101(b). the area supervisor serving the area in which the inspection was performed, INSPECTION CERTIFICATES and the remaining copies shall be disposed of in such manner as the Admin- § 354.140 Forms of inspection certificates. istrator may approve. Additional copies of any such certificate may be fur- Each inspection certificate issued nished to any interested party as pro- pursuant to the regulations in this part vided in § 354.105. shall be approved by the Administrator as to form, and: § 354.142 Food product inspection cer- (a) Each rabbit inspection certificate tificates; issuance and disposition. shall show the class or classes of rab- (a) Upon the request of an interested bits, the quantity of product contained in the respective lot, and all pertinent party, any inspector is authorized to information concerning the condition issue a food product inspection certifi- and wholesomeness thereof; cate with respect to any inspected and (b) Each food product inspection cer- certified edible product after suitable tificate shall show the names of the ed- examination of the product has been ible products covered by such certifi- made by the inspector. cate, the quantity of each such prod- (b) The original of each food product uct, such shipping marks as are nec- inspection certificate, and not to ex- essary to identify such products, and ceed two copies thereof, if requested, all pertinent information concerning shall, immediately upon issuance, be the condition and wholesomeness delivered or mailed to the applicant or thereof; person designated by him. Another (c) Each export certificate shall show copy shall be filed in the office of the the respective names of the exporter regional supervisor serving the area in and the consignee, the destination, the which such certificate was issued, and shipping marks, the numbers of the ex- one copy shall be forwarded to the Ad- port stamps attached to the edible ministrator. The last named two copies products to be exported and covered by shall be retained until otherwise or- the certificate, and the names of such dered by the Administrator.

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§ 354.143 Export certificates; issuance § 354.161 Requirements as to manner and disposition. of inspection. (a) Upon the request of an exporter, (a) The inspection shall be conducted any inspector is authorized to issue an by an inspector who is a qualified vet- export certificate with respect to the erinarian or under the supervision of a shipment to any foreign country of any qualified veterinarian. All such inspec- inspected and certified edible product tors shall be employed by the State, after suitable examination of the prod- county, city, or other political subdivi- uct has been made by the inspector. sion in which the official plant is lo- (b) Each export certificate shall be cated. issued in quintuplicate; the original (b) The inspection shall include post- shall be delivered to the exporter who mortem examination of each rabbit requested such certificate, and the du- carcass during the evisceration oper- plicate copy shall be delivered to the ation. agent of the railroad or other carrier (c) All carcasses which show evidence transporting such products from the of disease or any other condition which United States. The triplicate copy of may render them unwholesome or unfit such export certificate shall be for- for food shall be condemned and shall warded to the Administrator; the quad- be destroyed for food purposes under the supervision of an inspector. Each ruplicate copy shall be filed in the of- carcass and part thereof which has fice of the regional supervisor serving been inspected and passed or contain- the area in which such export certifi- ers of carcasses or parts thereof shall cate was issued, and the memorandum bear the identifying inspection symbol copy shall be retained by the inspector of the official inspection system and for filing. The last named three copies the marking devices or labels shall be shall be retained until otherwise or- in the custody of the inspector at all dered by the Administrator. times.

§ 354.144 Advance information. § 354.162 Determining compliance with Upon the request of an applicant, all § 354.161. or part of the contents of any inspec- A qualified veterinary supervisor of tion certificate issued to such appli- the rabbit inspection service shall in- cant may be telephoned or telegraphed vestigate the manner of operation of to him, or to any person designated by the inspection system to determine the him, at his expense. adequacy of the post-mortem examination and the compliance with the re- BASIS OF ACCEPTABILITY OF OTHER quirements contained in §§ 354.160 to OFFICIAL INSPECTION SYSTEMS 354.162 prior to approving the official plant for the inspection of ready-to- § 354.160 General. cook rabbits. This supervisor, as well Any rabbit inspection system may be as any official graders who may be sta- deemed to be acceptable to the Admin- tioned in the official plant, shall peri- istrator which: odically observe the inspection oper- (a) Is conducted under the authority ations in the official plant to deter- of laws, ordinances, or similar enact- mine that the requirements of §§ 354.160 ments of the State, county, city, or to 354.162 are being met. other political subdivision in which is SANITARY REQUIREMENTS located the official plant at which the ready-to-cook rabbits are prepared and GENERAL (b) Imposes at least the requirements set forth in § 354.161: Provided, That no § 354.210 Minimum standards for sani- such inspection shall be deemed ac- tation, facilities, and operating pro- ceptable to the Administrator with re- cedures in official plants. spect to any official plant in which The provisions of §§ 354.210 to 354.247 ready-to-cook rabbits are prepared if shall apply with respect to inspection he finds at any time that such require- service in all official plants. The table ments are not adequately enforced. set forth in § 354.247 indicates some of

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the types of material which may be (b) Rooms for holding carcasses for used in the construction of equipment, further inspection. Rooms and com- utensils, and facilities for use in the partments in which carcasses or parts plant. thereof are held for further inspection shall be in such number and such loca- BUILDINGS AND PLANT FACILITIES tion as the needs of the inspection in § 354.220 Buildings. the plant may require. They shall be equipped with locks and keys and the The buildings shall be of sound con- keys shall not leave the custody of the struction and kept in good repair, and inspector in charge of the plant. All shall be of such construction as to pre- such rooms and compartments shall be vent the entrance or harboring of vermin. marked conspicuously with the word (a) Outside openings. (1) The doors, ‘‘retained’’ in letters not less than 2 windows, skylights, and other outside inches high. openings of the plant, except receiving (c) Coolers and freezers. Coolers and rooms and live rabbit holding rooms, freezers of adequate size and capacity shall be protected by properly fitted shall be provided to reduce the internal screens or other suitable devices temperature of ready-to-cook rabbits against the entrance of flies and other prepared and otherwise handled in the insects. plant to 36 °F. within 24 hours unless (2) Outside doors, except in receiving other cooling facilities are available. rooms and live rabbit holding rooms, (d) Refuse rooms. Refuse rooms shall shall be self-closing and so hung that be entirely separate from other rooms not over 1⁄4–inch clearance remains in the plant, and shall have tight fit- when closed. Screen doors shall open ting doors and be properly ventilated. toward the outside of the building. (e) Storage and supply rooms. The § 354.221 Rooms and compartments. storage and supply rooms shall be in good repair, kept dry, and maintained Rooms and compartments used for in a sanitary condition. edible products shall be separate and (f) Boiler room. The boiler room shall distinct from inedible products depart- be a separate room, if necessary, to ments and from rooms where rabbits prevent its being a source of dirt and are slaughtered and skinned. Separate rooms shall be provided when required objectionable odors entering any room for conducting processing operations in where ready-to-cook rabbits are pre- a sanitary manner, and all rooms shall pared, processed, handled, and stored. be of sufficient size to permit the in- (g) Inspector’s office. Furnished of- stallation of the necessary equipment fice space, including, but not being for processing operations and the con- limited to, light, heat, and janitor duct of such operations in a sanitary service shall be provided rent free in manner. the official plant for the exclusive use (a) Rooms for separate operation. for official purposes of the inspector The official plant should have separate and the Administration. The room or rooms for each of the following oper- rooms set apart for this purpose must ations depending upon the various meet with the approval of the regional types of operations conducted, but, in supervisor and be conveniently located, no case, shall the receiving or holding properly ventilated, and provided with of live rabbits or killing operations be lockers or cabinets suitable for the pro- permitted in rooms in which eviscerat- tection and storage of supplies and ing operations are performed: with facilities suitable for inspectors (1) The receiving and feeding of live to change clothing. rabbits. (h) Toilet rooms. Toilet rooms open- (2) Killing and skinning operations. ing directly into rooms where rabbit (3) Eviscerating, chilling, and packing operations for ready-to-cook rab- products are exposed shall have self- bits. closing doors and shall be ventilated to (4) Inedible products departments. the outside of the building. (5) Refuse room.

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§ 354.222 Floors, walls, ceilings, etc. bottoms and be provided with suitable covers. (a) Floors. All floors in rooms where (3) Toilet soil lines shall be separate exposed products are prepared or han- from house drainage lines to a point dled shall be constructed of or finished outside the buildings unless they are with materials impervious to moisture, positively trapped to prevent backing so they can be readily and thoroughly up. Drainage from toilet bowls and uri- cleaned. The floors in killing, ice cool- nals shall not be discharged into a ing, ice packing, eviscerating, cooking, grease catch basin. boning, and cannery rooms shall be (4) All floor drains shall be equipped graded for complete runoff with no with traps, constructed so as to mini- standing water. mize clogging, and the plumbing shall (b) Walls, posts, partitions, doors. All be so installed as to prevent sewerage walls, posts, partitions, and doors in from backing up and from flooding the rooms where exposed products are pre- floor. pared or handled shall be smooth and (5) Floor drainage lines should be of constructed of materials impervious to metal and at least 4 inches in diameter moisture to a height of 6 feet above the and open into main drains of at least 6 floor to enable thorough cleaning. All inches in diameter and shall be prop- surfaces above this height must be erly vented to outside air. smooth and finished with moisture-re- (6) Where refrigerators are equipped sistant material. with drains, such drains should be (c) Ceilings. Ceilings must be mois- properly trapped and should discharge ture-resistant in rooms where exposed through an air gap into the sewer sys- products are prepared or handled, and tem. All new installations, and all re- finished and sealed to prevent collec- placements, or refrigerators equipped tion of dirt or dust that might sift with drains shall meet these require- through flooring above or fall from col- ments. lecting surfaces on equipment or exposed product. § 354.224 Water supply. The water supply shall be ample, § 354.223 Drainage and plumbing. clean, and potable with adequate facili- There shall be an efficient drainage ties for its distribution in the plant and plumbing system for the plant and and its protection against contamina- premises. tion and pollution. (a) Drains and gutters. All drains and (a) Hot water at a temperature not gutters shall be properly installed with less than 180 °F. shall be available for approved traps and vents. The drainage sanitation purposes. and plumbing system must permit the (b) Hose connections with steam and quick runoff of all water from plant water mixing valves or hot water hose buildings, and surface water around the connections shall be provided at con- plant and on the premises, and all such venient locations throughout the plant water shall be disposed of in such a for cleaning purposes. manner as to prevent a nuisance or (c) The refuse rooms shall be pro- health hazard. vided with adequate facilities for wash- (b) Sewage and plant wastes. (1) The ing refuse cans and other equipment in sewerage system shall have adequate the rooms; the rooms, cans, and equip- slope and capacity to remove readily ment shall be cleaned after each day’s all waste from the various processing use. operations and to minimize, and if possible to prevent, stoppage and sur- § 354.225 Lavatory accommodations. charging of the system. Modern lavatory accommodations (2) Grease traps which are connected and properly located facilities for with the sewerage system shall be suit- cleaning utensils and hands shall be ably located but not near any edible provided. products department or in any area (a) Adequate lavatory and toilet ac- where products are unloaded from or commodations, including, but not loaded into vehicles. To facilitate being limited to, running hot water cleaning, such traps shall have inclined and cold water, soap, and towels, shall

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be provided. Such accommodations EQUIPMENT AND UTENSILS shall be in or near toilet and locker rooms and also at such other places in § 354.230 Equipment and utensils. the plant as may be essential to the Equipment and utensils used for the cleanliness of all personnel handling preparation, processing, or other han- products. dling of any product in the plant shall (b) Sufficient metal containers shall be suitable for the purpose intended be provided for used towels and other and shall be of such material and con- wastes. struction as will facilitate their thor- (c) An adequate number of hand ough cleaning and insure cleanliness in washing facilities serving areas where the preparation and handling of prod- dressed rabbits and edible products are ucts. prepared shall be operated by other (a) Live rabbit holding pens shall be than hand-operated controls, or shall so constructed as to allow satisfactory be of a continuous flow type which pro- ante-mortem examination and to per- vides an adequate flow of water for mit proper cleaning. washing hands. (b) Metal refuse containers shall be (d) Durable signs shall be posted con- provided, and such containers shall be spicuously in each toilet room and kept covered. locker room directing employees to (c) Insofar as it is practical, equip- wash their hands before returning to ment and utensils shall be made of work. metal or other impervious material. Trucks and receptacles used for han- (e) Toilet facilities shall be provided dling inedible products shall be of simi- according to the following formula: lar construction and shall be conspicu- Toilet ously and distinctly marked and shall Persons of same sex bowls re- not be used for handling any edible quired products. 1 to 15, inclusive ...... 1 (d) Chilling vats or tanks used for 16 to 35, inclusive ...... 2 chilling ready-to-cook rabbits shall be 36 to 55, inclusive ...... 1 3 made of metal or other hard-surfaced 56 to 80, inclusive ...... 1 4 impervious material. For each additional 30 persons in excess of 80 ... 1 1 (e) Where grading bins are used for 1 Urinals may be substituted for toilet bowls but only to the ready-to-cook rabbits, they shall be of extent of 1¤3 of the total number of bowls stated. sufficient number and capacity to han- § 354.226 Lighting and ventilation. dle the grading adequately without the use of makeshift bins and all ready-to- There shall be ample light, either cook rabbits shall be kept off the floor. natural or artificial or both, of good Grading bins may be made of metal or quality and well distributed, and suffi- enameled wood and shall be con- cient ventilation for all rooms and structed and maintained in such a compartments to insure sanitary con- manner as to allow easy and thorough ditions. cleaning. All replacements of such bins (a) All rooms in which rabbits are shall, however, be of metal. killed, eviscerated, or otherwise proc- (f) Except as otherwise provided here- essed shall have at least 30 foot candles in, all equipment and utensils used in of light intensity on all working sur- the killing, skinning, eviscerating, faces except that at the inspection sta- chilling, and packing rooms shall be of tions such light intensity shall be of 50 metal or other impervious material foot candles. In all other rooms, there and constructed so as to permit proper shall be provided at least 5 foot candles and complete cleaning. of light intensity when measured at (g) Conveyors: (1) Conveyors used in distance of 30 inches from the floor. the preparation of ready-to-cook rab- (b) All rooms shall be adequately bits shall be of metal or other accept- ventilated to eliminate objectionable able material and of such construction odors and minimize moisture condensa- as to permit thorough and ready clean- tion. ing and easy identification of viscera with its carcass.

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(2) Overhead conveyors shall be so inspector in charge of the plant. Such constructed and maintained that they trucks and receptacles shall be marked do not allow grease, oil, or dirt to accu- conspicuously with the word ‘‘re- mulate on the drop chain or shackle, tained’’ in letters not less than 2 inches which shall be of noncorrosive metal. high. (3) Nonmetallic belt-type conveyors used in moving edible products shall be § 354.231 Accessibility. of water-proof composition. All equipment shall be so placed as to (h) Inspection, eviscerating, and cut- be readily accessible for all processing ting tables shall be made of metal and and cleaning operations. have coved corners and be so constructed and placed to permit thorough § 354.232 Restrictions on use. cleaning. Equipment and utensils used in the (i) In plants where no conveyors are official plant shall not be used outside used, each carcass shall be eviscerated the official plant except under such in an individual metal tray of seamless conditions as may be prescribed or ap- construction. proved by the national supervisor, and (j) Water spray washing equipment equipment used in the preparation of shall be used for washing carcasses in- any article (including, but not being side and out. limited to, animal food) from inedible (k) Watertight metal receptacles material shall not be used outside of shall be used for entrails and other the inedible products department ex- waste resulting from preparation of cept under such conditions as may be ready-to-cook rabbits. prescribed or approved by the national (l) Watertight trucks and receptacles supervisor. for holding or handling diseased carcasses and diseased parts of carcasses MAINTENANCE OF SANITARY CONDITIONS shall be so constructed as to be readily AND PRECAUTIONS AGAINST CON- and thoroughly cleaned; such trucks TAMINATION OF PRODUCTS and receptacles shall be marked in a conspicuous manner with the word § 354.240 General. ‘‘condemned’’ in letters not less than 2 inches high and, when required by the The premises shall be kept free from inspector in charge, shall be equipped refuse, waste materials, and all other with facilities for locking and sealing. sources of objectionable odors and con- (m) Freezing rooms should be ade- ditions. quately equipped to freeze ready-to- § 354.241 Cleaning of rooms and com- cook rabbits solid in less than 48 hours. partments. Ready-to-cook rabbits should be frozen at temperatures of ¥10 °F. to ¥40 °F. Rooms, compartments, or other parts and should be stored at 0 °F. or below, of the official plant shall be kept clean with the temperature maintained as and in sanitary condition. constant as possible. Freezing room (a) All blood, offal, rabbits or parts of should be equipped with floor racks or rabbits too severely damaged to be pallets and fans to insure air circula- salvaged and all discarded containers tion. and other materials shall be com- (n) Cooling racks should be made of pletely disposed of daily. metal and be readily accessible for (b) All windows, doors, and light fix- thorough washing and cleaning. All re- tures in the official plant shall be kept placements of cooling racks shall be clean. made of metal. (c) All docks and rooms shall be kept (o) Trucks and receptacles in which clean and free from debris and unused carcasses or parts thereof are held for equipment and utensils. further inspection shall be in such (d) Live rabbit receiving docks and number and such location as the needs receiving rooms shall be of such con- of the inspection in the plant may re- struction as readily to permit their quire. They shall be equipped for lock- thorough cleaning, and such docks and ing by means of lock and key and the rooms should be kept clean at all key shall not leave the custody of the times.

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(e) Floors in live rabbit holding may be approved or prescribed by the rooms shall be cleaned with such regu- Administrator. larity as may be necessary to maintain (f) When synchronized overhead con- them in a sanitary condition. veyors and tray conveyors are used, (f) The killing and skinning room the trays shall be completely washed shall be kept clean and free from offen- and sanitized after being automatically sive odors at all times. emptied of inedible viscera. (g) The walls, floors, and all equip- (g) When a conveyor tray operation is ment and utensils used in the killing used, each carcass shall be eviscerated and skinning room shall be thoroughly in an individual metal tray of seamless washed and cleaned after each day’s op- construction, and such trays shall be eration. completely washed and sanitized after (h) The floor in the killing and skin- each use. ning rooms shall be cleaned frequently (h) Tables, shelves, bins, trays, pans, during killing and skinning operations knives, and all other tools and equip- and be kept reasonably free from accu- ment used in the preparation of ready- mulated blood, offal, water, and dirt. to-cook rabbits shall be kept clean and (i) All equipment in the toilet room sanitary at all times. Cleaned equip- and locker room, as well as the room ment and utensils shall be drained on itself, shall be kept clean, sanitary, racks and shall not be nested. and in good repair. (i) Drums, cans, tanks, vats, and (j) Cooler and freezer rooms shall be other receptacles used to hold or trans- free from objectionable odors of any port ready-to-cook rabbits shall be kind and shall be maintained in a sani- kept in a clean and sanitary condition. tary condition (including, but not being limited to, the prevention of § 354.243 Operations and procedures. drippings from refrigerating coils onto Operations and procedures involving products). the preparation, storing, or handling of § 354.242 Cleaning of equipment and any product shall be strictly in accord utensils. with clean and sanitary methods. Equipment and utensils used for pre- (a) There shall be no handling or paring or otherwise handling any prod- storing of materials which create an uct shall be kept clean and in a sani- objectionable condition in rooms, com- tary condition and in good repair. partments, or other places in the plant (a) Pens shall be cleaned regularly where any product is prepared, stored, and the manure removed from the or otherwise handled. plant daily. (b) Blood from the killing operation (b) All equipment and utensils used shall be confined to a relatively small in the killing and skinning rooms shall area and kept from being splashed be thoroughly washed and cleaned after about the room. each day’s operation. The eviscerating, (c) In the final washing, the carcass chilling, and packing room and equip- shall be passed through a system of ment and utensils used therein shall be sprays providing an abundant supply of maintained in a clean and sanitary fresh clean water. condition. (d) The floors in the eviscerating (c) Graders’ and packers’ gloves and room shall be kept clean and reason- grading bins shall be washed daily and ably dry during eviscerating operations used only for grading or packing, as and free of all refuse. the case may be. (e) Conveyors shall be operated at (d) All crates or pens used for trans- such speeds as will permit a sanitary porting live rabbits to the plant shall eviscerating operation and will permit be cleaned regularly. adequate inspection for condition and (e) Chilling vats or tanks, if prac- wholesomeness. ticable, shall be emptied after each (f) Mechanized packaging equipment use. They shall be thoroughly cleaned shall be maintained in good sanitary once daily and, after each cleaning op- condition. eration, they shall be sanitized with (g) All offal resulting from the evis- such compounds or by such methods as cerating operation shall be removed as

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often as necessary to prevent the devel- (a) Cooling. Immediately after evis- opment of a nuisance. ceration and washing of the carcass, it (h) Paper and other material used for shall be placed in a cooling tank con- lining containers in which products are taining running cold tap water to re- packaged shall be of such kinds as do move the animal heat from the carcass. not tear readily during use, but remain Carcasses shall not be allowed to re- intact when moistened by the product. main in the cooling tank for longer Wooden containers to be used for pack- than 1 hour. aging ready-to-cook rabbits shall be (b) Air chilling. Immediately after the fully lined except when the individual initial water chilling, the carcasses carcasses to be packaged therein are shall be placed in cooling racks and fully wrapped. thereupon placed in a refrigerated cool- (i) Protective coverings shall be used er with moderate air movements and a for the product in the plant and as it is temperature which will reduce the in- distributed from the plant, as will af- ternal temperature of the carcasses to ford adequate protection for the prod- from 36 °F. to 40 °F., both inclusive, uct against contamination by any for- within 24 hours. eign substance (including, but not (c) Freezing. (1) When ready-to-cook being limited to, dust, dirt, and in- rabbits are packaged in bulk or ship- sects), considering the means intended ping containers, the carcasses should to be employed in transporting the be individually wrapped or packaged in product from the plant. water-vapor resistant cartons or the (j) Refuse may be moved directly to containers should be lined with heavy loading docks only for prompt removal. water-vapor resistant paper so as to as- (k) Cleanliness and hygiene of per- sure adequate overlapping of the lining sonnel: (1) All employees coming in to completely surround the carcasses contact with exposed edible products or and to permit unsealed closure or seal- edible products handling equipment ing in such a manner that water-vapor shall wear clean garments and should loss from the product is considerably wear caps or hair nets, and shall keep retarded or prevented. The rabbit car- their hands clean at all times while casses should receive an initial rapid thus engaged. freezing under such packaging, tem- (2) Hands of employees handling edi- perature, air circulation, and stacking ble products or edible products han- conditions which will result in freezing dling equipment shall be free of in- the carcasses solid in less than 48 fected cuts, boils, and open sores at all hours. times while thus engaged. (2) Frozen ready-to-cook rabbits shall (3) Every person, after each use of be held under conditions which will toilet or change of garments, shall maintain the product in a solidly fro- wash his hands thoroughly before re- zen state with temperature maintained turning to duties that require the han- as constant as possible. dling of edible products or containers (d) Refrigeration. Immediately after therefor or edible products handling packaging, all ready-to-cook rabbits, equipment. other than those which are shipped (4) Neither smoking nor chewing of from the plant in a refrigerated carrier, tobacco shall be permitted in any room should be moved into the freezer, ex- where exposed edible products are pre- cept that a period not exceeding 72 pared, processed, or otherwise handled. hours will be permitted for transportation and temporary holding before § 354.244 Temperatures and cooling placing in the freezer provided such and freezing procedures. rabbits are held at not above 36 °F. Temperatures and procedures which are necessary for cooling and freezing § 354.245 Vermin. of rabbits in accordance with sound Every practicable precaution shall be commercial practice shall be main- taken to exclude flies, rats, mice, and tained in the coolers and freezers, and other vermin from the official plant. chilling temperatures and procedures Dogs, cats, and other pets shall be ex- shall also be in accordance with sound cluded from rooms where edible prod- commercial practice. ucts are processed, handled, or stored.

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§ 354.246 Exclusion of diseased per- transmissible stage shall be permitted sons. in any room or compartment where ex- No person affected with any commu- posed or unpacked edible products are nicable disease (including, but not prepared, processed, or otherwise han- being limited to, tuberculosis) in a dled.

§ 354.247 Table showing types of materials.

Stainless Equipment, utensils, and facilities Iron steel and Alu- Galvanized monel metal minum iron

Holding pens ...... A A A A Overhead conveyors ...... A A A A Conveyor track ...... A A ...... A Shackles ...... A ...... A Shackle chain ...... A A ...... A Eviscerating pans ...... A A A Inspection table ...... A A A Inside and outside washer ...... A A A Cooling tanks and racks ...... A A A Utensils for handling edible products ...... A A A Framework (of equipment) ...... A ...... Key: AÐAcceptable.

§ 354.248 Scope and applicability of 355.8 Official number. rules of practice. 355.9 Numbers granted same ownership or control. The rules of practice of the Depart- 355.10 Assignment of inspectors. ment of Agriculture in subpart H of part I, subtitle A, title 7 of the Code of FEES Federal Regulations, are the rules of 355.11 Charge for survey. practice applicable to adjudicatory, ad- 355.12 Charge for service. ministrative proceedings under the regulations in this part (9 CFR part 354). SANITATION AND FACILITIES [43 FR 11148, Mar. 17, 1978] 355.13 Sanitation. 355.14 Facilities. 355.15 Inedible material operating and stor- PART 355—CERTIFIED PRODUCTS age rooms; outer premises, docks, drive- FOR DOGS, CATS, AND OTHER ways, etc.; fly-breeding material; CARNIVORA; INSPECTION, CER- nuisances. TIFICATION, AND IDENTIFICA- 355.16 Control of flies, rats, mice, etc. 355.17 Tagging equipment ‘‘U.S. rejected.’’ TION AS TO CLASS, QUALITY, 355.18 Drawings and specifications to be fur- QUANTITY, AND CONDITION nished.

INSPECTION PROCEDURE DEFINITIONS Sec. 355.19 Inspector to be informed when plant 355.1 Meaning of words. operates. 355.2 Terms defined. 355.20 Inspector to have access to plant at all times. SCOPE OF INSPECTION SERVICE 355.21 Products entering inspected plants. 355.22 Designation of place of receipt of re- 355.3 Plants eligible for inspection. turned products. APPLICATION FOR INSPECTION, CERTIFICATION, 355.23 Tagging products ‘‘U.S. retained.’’ AND IDENTIFICATION 355.24 Processes to be supervised. 355.25 Canning with heat processing and 355.4 Application. hermetically sealed containers; closures; 355.5 Drawings. code marking; heat processing; incuba- 355.6 Review of applications. tion. 355.26 Samples of certified products, ingre- INAUGURATION OF INSPECTION dients, etc., to be taken for examination. 355.7 Inauguration of inspection. 355.27 Reports of violations of regulations.

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DISPOSAL OF CONDEMNED MATERIAL group of persons, whether incorporated 355.28 Unfit material to be condemned. or not. (b) Program means the Meat and COMPOSITION OF CERTIFIED PRODUCTS Poultry Inspection Program of the 355.29 Composition of certified products for Food Safety and Inspection Service of dogs, cats, and other carnivora. the United States Department of Agri- culture. SUPERVISION (c) Circuit supervisor means an inspec- 355.31 Supervision by inspector. tor of the Program assigned to super- LABELING vise and perform official work at a circuit. Such inspector is assigned by and 355.32 Labeling required. reports directly to the Administrator 355.33 Plant number to be embossed on metal containers. or other person designated by him. 355.34 Labels, approval of, by Adminis- (d) Inspector means an inspector of trator. the Program. 355.35 Label information to be displayed on (e) Inspected plant means any plant principal panel. preparing certified products for dogs, 355.36 Obsolete labels. cats, or other carnivora at which in- 355.37 Alteration or limitation of statement spection is maintained under the regu- of certification. lations contained in this part. PENALTIES (f) Circuit means one or more in- 355.38 Withdrawal of service. spected plants assigned to a circuit supervisor. APPEALS (g) Animal protein supplement means a 355.39 Appeals from decisions made under product containing animal protein and this part. other elements normal to the component for use in compounding a mainte- REPORTS nance food for dogs, cats, and other 355.40 Plants to furnish information for re- carnivora. ports. (h) Products means the products for dogs, cats, and other carnivora MULE MEAT AND ANIMAL FOOD, MULE MEAT BY-PRODUCT marked, or to be marked, with the certification provided in this part. 355.41 Antemortem and postmortem inspec- (i) Meat means the U.S. inspected and tion for mules. 355.42 Marking of mule meat and animal passed and so identified clean, whole- food mule meat by-product. some muscle tissue of cattle, sheep, 355.43 Scope and applicability of rules of swine, or goats which is skeletal or practice. which is found in the tongue, in the di- AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 aphragm, in the heart, or in the esoph- (g) and (i), 2.55. agus with or without the accompany- SOURCE: 23 FR 10107, Dec. 23, 1958, unless ing and overlying fat and the portions otherwise noted. Redesignated at 30 FR 4195, of skin, sinews, nerves, and blood ves- Mar. 31, 1965. sels which normally accompany the muscle tissue and which are not sepa- DEFINITIONS rated from it in the process of dressing. It does not include the muscle found in § 355.1 Meaning of words. the lips, snout, or ears. Words used in this part in the sin- (j) Animal food meat by-product means gular form shall be deemed to import the part other than meat which has the plural, and vice versa, as the case been derived from one or more cattle, may demand. sheep, swine or goats that have been U.S. Inspected and Passed and is fit for § 355.2 Terms defined. use as animal food. When used in this part unless other- (k) Horse meat means the U.S. in- wise distinctly expressed or manifestly spected and passed and so identified incompatible with the intent thereof: clean, wholesome muscle tissue of (a) Person means any individual, horses which is skeletal or which is partnership, association, business found in the tongue, in the diaphragm, trust, corporation, or any organized in the heart, or in the esophagus, with

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or without the accompanying and over- (s) Whale meat means the muscle tis- lying fat and the portions of sinews, sue of whales which is fit for use in ani- nerves, and blood vessels which normal food. mally accompany the muscle tissue (t) Fish means the whole or part of and which are not separated from it in any aquatic, water breathing verte- the process of dressing. brates, commonly designated as fish, (l) Animal food horse meat by-product which is fit for use in animal food. means the part other than meat which (u) Animal food poultry byproduct has been derived from one or more means any portion of carcasses of poul- horses that have been U.S. Inspected try slaughtered under inspection and and Passed and is fit for use as animal passed in accordance with the Poultry food. Products Inspection Act which is fit for (m) Mule meat means the clean, use in animal food. sound, healthful, wholesome muscle [23 FR 10107, Dec. 23, 1958, as amended at 25 tissue derived from mules as deter- FR 1356, Feb. 1960; 29 FR 18418, Dec. 25, 1964. mined by antemortem and postmortem Redesignated and amended at 30 FR 4195, inspection by an inspector in accord- Mar. 31, 1965; 32 FR 13115, Sept. 15, 1967; 33 FR ance with § 355.41. It includes muscle 6707, May 2, 1968] tissue which is found in the tongue, in the diaphragm, in the heart or in the SCOPE OF INSPECTION SERVICE esophagus, with or without the accom- § 355.3 Plants eligible for inspection. panying and overlying fat and the portions of sinews, nerves, and blood ves- Upon application, inspection may be sels which normally accompany the granted at a plant where products are muscle tissue and which are not sepa- to be prepared, when the Administrator rated from it in the process of dressing. has determined that the application (n) Animal food mule meat by-product conforms to and the plant meets with means the part other than meat which the requirements of this part. has been derived from one or more mules that have been handled in ac- APPLICATION FOR INSPECTION, cordance with § 355.41 and is fit for use CERTIFICATION, AND IDENTIFICATION as animal food. § 355.4 Application. (o) Bone means the U.S. inspected and passed and so identified clean, The owner or operator of any plant of wholesome bone which has been de- the kind specified in § 355.3 may apply rived from cattle, sheep, swine, goats to the Administrator for inspection, or horses, or bone derived from mules certification, and identification. In slaughtered and passed under Program cases of change of ownership or change inspection in accordance with § 355.41. of location, new applications shall be (p) Poultry means any domesticated made. bird slaughtered in accordance with (Approved by the Office of Management and the Poultry Products Inspection Act, Budget under control number 0583–0036) Public Law 85–172, 85th Congress, S. [23 FR 10107, Dec. 23, 1958. Redesignated at 30 1747, dated August 28, 1957 (21 U.S.C. 451 FR 4195, Mar. 31, 1965, and amended at 47 FR et seq.). 746, Jan. 7, 1982] (q) Poultry product means any edible part of fresh poultry which have been § 355.5 Drawings. slaughtered for human food and from Triplicate copies of complete draw- which the blood, feathers, feet, head ings with specifications, consisting of and viscera have been removed in ac- floor plans showing the locations of cordance with rules and regulations such features as the principal pieces of promulgated by the Secretary of Agri- equipment, floor drains, principal culture. drainage lines, hand-washing basins, (r) Administrator. The Administrator and hose connections for cleanup pur- of the Food Safety and Inspection poses; elevations; roof plans when nec- Service or any officer or employee of essary to show size and location of sky- the Department to whom authority has lights and the like; cross and longitu- heretofore been delegated or may here- dinal sections of the various buildings, after be delegated to act in his stead. showing such features as principal

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pieces of equipment, heights of ceil- number in each case to identify the ings, conveyor rails, and character of plant. floors, walls, and ceilings; and a plot plan showing relationship of various § 355.10 Assignment of inspectors. departments and structures of the The Administrator shall designate a plants, properly drawn to scale, shall circuit supervisor of the inspection at accompany applications. Where com- each circuit and assign to him such as- plete approved drawings and specifica- sistants as may be necessary. tions are available in the files of the Meat and Poultry Inspection Program, FEES Food Safety and Inspection Service, U.S. Department of Agriculture, cover- § 355.11 Charge for survey. ing a plant operating under the super- Applicants for the inspection, certifi- vision of that Program, it will not be cation, and identification shall reim- necessary that drawings and specifica- burse the department for salary, travel tions accompany an application made cost, per diem allowance, and the like, under this part for inspection at such expended incidental to any survey of plant. the premises for which the inspection is requested, and in connection with [23 FR 10107, Dec. 23, 1958. Redesignated and any review of plans which may be amended at 30 FR 4195, Mar. 31, 1965; 32 FR made. 13115, Sept. 15, 1967] § 355.12 Charge for service. § 355.6 Review of applications. The fees to be charged and collected The Administrator will determine by the Administrator shall be at the whether applications shall be granted rates specified in §§ 391.2, 391.3, and 391.4 or refused. respectively for base time; for overtime, including Saturdays, Sundays, INAUGURATION OF INSPECTION and holidays; and for certain laboratory services which are not covered § 355.7 Inauguration of inspection. under the base time, overtime, and/or When an application for inspection, holiday costs. Such fees shall reim- certification, and identification is burse the Service for the cost of the in- granted, the circuit supervisor shall, at spection service furnished. or prior to the inauguration of inspection, inform the owner or operator of [54 FR 6390, Feb. 10, 1989] the plant of the requirements of the SANITATION AND FACILITIES regulations contained in this part. In- spection shall not be begun if a plant is § 355.13 Sanitation. not in a sanitary condition. The appli- Sanitary facilities and accommoda- cant shall adopt and enforce all nec- tions shall be furnished by every in- essary measures and shall comply with spected plant. Of these the following all such directions as the circuit super- are specifically required: visor may prescribe for carrying out (a) Dressing rooms, toilet rooms, and the purposes of this part. urinals shall be sufficient in number, ample in size, and conveniently lo- § 355.8 Official number. cated. They shall be properly lighted To each plant granted inspection an and ventilated and of sanitary con- official number shall be assigned. Such struction. They shall be separate from number shall be preceded by the letter the rooms and compartments in which ‘‘A’’ and used to identify all certified certified products are prepared, stored products prepared in the plant. or handled. (b) Modern hand-washing basins, in- § 355.9 Numbers granted same owner- cluding running hot and cold water, ship or control. soap and towels shall be placed in or Two or more official plants under the near toilet rooms. same ownership or control may be (c) Toilet soil lines shall be separate granted the same official number, pro- from house drainage lines to a point vided a serial letter is added after the outside the buildings and drainage

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from toilet soil lines shall not be dis- shall be provided rent free for the ex- charged into a grease catchbasin. clusive use of the inspector. These fa- (d) Properly located facilities shall cilities shall be set apart for this pur- be provided for cleansing utensils and pose and provided with lockers suitable hands of all persons handling or prepar- for the protection and storage of pro- ing any products to be certified. gram supplies. Laundering of inspec- (e) Equipment and utensils used for tors’ outer work clothing shall be pro- preparing any products to be certified vided by the management of inspected shall be of such material and construc- plants. tion as will make them susceptible of being readily and thoroughly cleaned. § 355.15 Inedible material operating (f) Trucks and receptacles used for and storage rooms; outer premises, inedible materials shall be of such con- docks, driveways, etc.; fly-breeding struction as to permit ready and thor- material; nuisances. ough cleansing, shall bear a conspicu- All operating and storage rooms and ous and distinctive mark, and shall be departments of inspected plants used used exclusively for handling inedible material. for inedible material shall be main- (g) Rooms, compartments, places, tained in clean condition, and shall be equipment and utensils used for prepar- separate and apart from rooms and de- ing, storing or otherwise handling any partments where certified products are certified products, and all other parts prepared, handled, or stored. Docks and of the inspected plant, shall be kept areas where cars and vehicles are load- clean. There shall be no handling or ed, and driveways, approaches and al- storing of materials which creates an leyways shall be properly paved and objectionable condition in rooms, com- drained and the outer premises of every partments or places where certified inspected plant shall be kept in clean products are prepared, stored or other- and orderly condition. All catchbasins wise handled. on the premises shall be of such construction and location and shall be § 355.14 Facilities. given such attention as will insure Adequate facilities for the prepara- their being kept in acceptable condition and inspection of the products to tion as regards odors and cleanliness. be certified shall be furnished and The accumulation on the premises of maintained by the inspected plant. Of any material in which flies may breed, these the following are specifically re- or the maintenance of any nuisance on quired: the premises shall not be allowed. (a) A room or compartment adequately equipped for locking or sealing § 355.16 Control of flies, rats, mice, etc. shall be provided for holding products prepared for certification or material Flies, rats, mice, and other vermin used in their preparation which are shall be excluded from inspected plants identified as ‘‘U.S. retained,’’ and such and premises. rooms and compartments shall be conspicuously marked with the phrase § 355.17 Tagging equipment ‘‘U.S. re- ‘‘U.S. retained’’ prominently displayed. jected.’’ (b) Adequate facilities, including de- When necessary, inspectors shall at- naturing materials, for the proper dis- tach a ‘‘U.S. rejected’’ tag to any posal of condemned articles including equipment or utensil which is unclean carcasses, parts of carcasses and other or the use of which would be in conflict materials, shall be provided. with the provisions of this part. No (c) Rooms or compartments adequate equipment or utensil so tagged shall in size and properly equipped for hold- again be used until made acceptable ing samples of canned products pre- under this part and until removal of pared for certification under incuba- the tag. Such tag shall not be removed tion, shall be maintained at the tem- from the equipment or utensil by any- perature specified in § 355.25(i). one other than an inspector. (d) Furnished office room, including light, heat, janitor, and laundry service

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§ 355.18 Drawings and specifications § 355.23 Tagging products ‘‘U.S. re- to be furnished. tained.’’ Triplicate copies of complete draw- A ‘‘U.S. Retained’’ tag shall be placed ings and specifications for remodeling by an inspector at the time of inspec- inspected plants or for new structures tion on all certified products, mate- at such plants shall be submitted to rials to be used in the preparation of the Administrator and approval ob- certified products, or containers there- tained for the plans in advance of con- of, whenever such certified products, struction. materials, or containers are suspected of being unsound or otherwise unfit or INSPECTION PROCEDURE not in conformity with the requirements contained in this part. Such tags § 355.19 Inspector to be informed when so placed shall not be removed by any- plant operates. one other than an inspector. The management of an inspected plant shall inform the inspector or the § 355.24 Processes to be supervised. circuit supervisor when work in each All processes used in the preparation department has been concluded for the of the certified products shall be super- day, and the day and hour when work vised by an inspector. All steps in the will be resumed therein. There shall be process of manufacture shall be con- no preparation of certified products at ducted carefully and with strict clean- an inspected plant except under the su- liness. Inspected plants shall not pre- pervision of an inspector. pare products of a kind certified under this part unless they conform with the § 355.20 Inspector to have access to plant at all times. regulations contained in this part. For the purpose of examination or in- § 355.25 Canning with heat processing spection necessary to enforce any of and hermetically sealed containers; the provisions of this part, inspectors closures; code marking; heat proc- shall have access at all times by day or essing; incubation. night, whether the plant is being oper- (a) Containers shall be cleaned thor- ated or not, to every part of an in- oughly immediately before filling, and spected plant. precaution must be taken to avoid soiling the inner surfaces subsequently. § 355.21 Products entering inspected (b) The inside surfaces of containers plants. of metal, glass, or other material shall All products of a kind certified under be washed by spraying in an inverted this part or materials to be used in the position with running water at a tem- preparation of such products when perature of at least 180 °F. The con- brought into an inspected plant shall tainer washing equipment shall be probe identified and inspected at the time vided with a thermometer to register of receipt and be subject to further in- the temperature of the water used for spection in such manner and at such cleaning the containers. time as may be deemed necessary. If, (c) Perfect closure is required for her- upon inspection, any such article is metically sealed containers. Heat proc- found to be unsound or otherwise unfit, essing shall follow promptly after clos- it shall be handled as provided in ing. § 355.28. (d) Careful inspection shall be made of the containers by competent plant § 355.22 Designation of place of receipt employees immediately after closing, of returned products. and containers which are defectively Certified products returned to an in- filled or defectively closed, or which spected plant shall be received at a show inadequate vacuum, shall not be dock or place specifically designated further processed until the defect has for the purpose by the plant manage- been corrected. The containers shall ment with the approval of the circuit again be inspected by plant employees supervisor. Such returned products when they have cooled sufficiently for shall be inspected there by the inspec- handling after processing by heating. tor before further entering the plant. The contents of defective containers

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shall be condemned unless correction The incubation shall consist of holding of the defect is accomplished within six the canned products for at least 10 days hours following the sealing of the con- at about 98 °F. The extent to which in- tainers or completion of the heat proc- cubation tests shall be required by in- essing, as the case may be, except that spectors depends on conditions such as (1) if the defective condition is discov- the record of the inspected plant in ered during an afternoon run the cans conducting canning operations, the ex- of product may be held in coolers at a tent to which the plant furnishes com- ° temperature not exceeding 38 F. under petent supervision and inspection in conditions that will promptly and ef- connection with the canning oper- fectively chill them until the following ations, the character of the equipment day when the defect may be corrected; used, and the degree to which such and (2) short vacuum or overstuffed equipment is maintained at maximum cans of products which have not been efficiency. Such factors shall be consid- handled in accordance with the above ered by the circuit supervisor in deter- may be incubated as provided in paragraph (i) of this section in the in- mining the extent of incubation testing spected plant under Program super- at a particular plant. In the event of vision, after which the cans shall be failure by an inspected plant to provide opened and the sound products passed. suitable facilities for incubation of test (e) Canned products shall not be samples, the circuit supervisor may re- passed unless, after cooling to atmos- quire holding of the entire lot under pheric temperature, they show the ex- such conditions and for such period of ternal characteristic of sound cans; time as may, in his discretion, be nec- that is, the cans shall not be overfilled, essary to establish the stability of the the ends of the cans shall be concave, canned products. The circuit supervisor there shall be no bulging of the cans, may permit lots of canned certified the sides and ends of the cans shall products to be shipped from the in- conform to the products, and there spected plant prior to completion of shall be no slack or loose tin in the sample incubation when he has no rea- cans. son to suspect unsoundness in the par- (f) All canned products shall be plain- ticular lots, and under circumstances ly and permanently marked on the con- which will assure the return of the tainers by code or otherwise with the products to the plant for inspection identity of the contents and date of should such action be indicated by the canning. The code used and its mean- incubation results. ing shall be on record in the office of the circuit supervisor before use. § 355.26 Samples of certified products, (g) The canned products must be ingredients, etc., to be taken for ex- processed at such temperature and for amination. such period of time as will assure keep- Samples of certified products, water, ing without refrigeration under usual chemicals, flavorings or other articles conditions of storage and transpor- in an inspected plant shall be taken tation as evidenced by the incubation without cost to the Program for an ex- test. amination as often as may be deemed (h) Lots of canned products shall be necessary for the efficient conduct of identified during their handling preparatory to and during heat processing the inspection. The frequency of sam- by tagging the baskets or cages in pling shall be determined by the needs which the cans are being conveyed, of the inspection. with a tag which will change color on § 355.27 Reports of violations of regu- going through the heat processing or lations. by other effective means so as to insure the proper channeling of the products Inspectors shall report to the circuit for effective heat processing after clos- supervisor violations of or failures to ing the cans. conform with these regulations which (i) Facilities shall be provided to in- occur at inspected plants, and the cir- cubate at least representative samples cuit supervisor shall report the same to of the fully processed canned products. the Administrator.

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DISPOSAL OF CONDEMNED MATERIAL (3) Certified maintenance food shall contain not less than 10 percent of pro- § 355.28 Unfit material to be con- tein. demned. (4) Certified maintenance food shall Subject to § 355.41, any certified prod- contain a level of minerals and vita- ucts, or ingredients intended for use mins generally recognized to be essen- therein, which are decomposed or adul- tial to the nutritional value of the terated or otherwise unsound or unfit food. for use shall be condemned and de- (5) Vegetables and grains and their stroyed, except that if the adulteration derivatives, used as ingredients of cer- is such as will not preclude their legiti- tified maintenance food, shall be of mate use for some purpose other than good quality, shall be free from discol- the preparation of the certified prod- oration, mold, smut, and insect infesta- ucts, they may be released by author- tion, and shall be otherwise fit for use ized inspectors for such other purpose as animal food. for disposition under the supervision of (6) Inedible material such as tankage, the proper local, State, or Federal offi- dried blood, bone meal, and the like cial. The operator of the inspected shall not be used as ingredients of cer- plant shall make such arrangement as tified maintenance food. may be necessary with the proper offi- (7) Semi-moist certified maintenance cials for the disposition of the article. food shall have a soft granular consistency, shall be shelf stable, and shall be COMPOSITION OF CERTIFIED PRODUCTS processed so that the moisture content thereof does not exceed 27 percent of § 355.29 Composition of certified prod- the net weight of such food. ucts for dogs, cats, and other (b) Composition of canned or fresh fro- carnivora. zen certified supplemental animal foods. (a) Composition of canned or semi-moist (1) Certified animal protein supplement certified maintenance food. (1) Only in- shall comply with the following re- gredients which are normal to canned quirements: or semi-moist food for dogs, cats, and (i) Certified animal protein supple- other carnivora, which are favorable to ment shall contain not less than 95 per- adequate nutrition, and which are cent of meat or animal food meat by- classed by the Administrator as con- product or both, or of horse meat or forming with requirements contained animal food horse meat byproduct or in this part shall be used in the prepa- both, or of mule meat or animal food ration of certified maintenance food. mule meat byproduct or both, or of (2) Not less than 30 percent of meat poultry products. Upon specific ap- or animal food meat byproduct or both, proval of the Administrator, combina- or of horse meat or animal food horse tions of the above specified ingredients meat byproduct or both, or of mule may be used; meat or animal food mule meat by- (ii) Certified animal protein supple- product or both, or of poultry products, ment shall have added thereto a suffi- shall be used in the preparation of cient amount of fresh ground bone or canned or semimoist certified mainte- other acceptable agent to satisfy the nance food. Upon specific approval of requirements of the regulations pro- the Administrator, combinations of the mulgated under the Meat Inspection above specified ingredients may be Act (34 Stat. 1260), as amended (21 used. The uncooked weight of the meat U.S.C. 71 et seq.), and the Horse Meat or animal food meat byproduct or both, Act (41 Stat. 241; 21 U.S.C. 96), in order or of the horse meat or animal food to insure decharacterization of the horse meat byproduct or both, or of the product for human food purposes; mule meat or animal food mule meat (iii) Certified animal protein supple- byproduct or both, or of the poultry ment may contain not more than 3 per- products, or of the combinations there- cent wheat flour or other processing of, shall be used in the calculation, and aid acceptable to the Administrator, the percentage shall be obtained by re- which shall be of good quality, shall be lating this weight to the total weight free from insect infestation, and shall of the certified maintenance food. be otherwise fit for use as animal food;

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(iv) Certified animal protein supple- proval of the Administrator, combina- ment shall contain not less than 15 per- tions of the above specified ingredients cent protein; and may be used. (v) Certified animal protein supple- (2) Certified variety pet food shall ment shall contain not less than 3 per- contain a variety of vegetables and cent fat. may contain other ingredients which (2) Certified pet food supplement are favorable to adequate nutrition. shall comply with the following re- (3) Vegetables and grains and their quirements: derivatives used as ingredients of cer- (i) Certified pet food supplement shall contain not less than 50 percent tified variety pet food shall be of good of meat or animal food meat byproduct quality, shall be free from discolora- or both, or of horse meat or animal tion, mold, smut, and insect infesta- food horse meat byproduct or both, or tion, and shall be otherwise fit for use of mule meat or animal food mule as animal food. meat byproduct or both, or of poultry (4) Certified variety pet food shall products. Upon specific approval of the contain not less than 8 percent protein. Administrator, combinations of the (5) Certified variety pet food shall above specified ingredients may be contain not less than 2 percent fat. used; (6) Certified variety pet food may (ii) Certified pet food supplement contain not more than 75 percent mois- shall have added thereto a sufficient ture. amount of fresh ground bone or other (d) Certified products for dogs, cats, acceptable agent to satisfy the requirements of the regulations promulgated and other carnivora may contain whale under the Meat Inspection Act (34 Stat. meat, fish, and animal food poultry by- 1260), as amended (21 U.S.C. 71 et seq.), products or combinations thereof as and the Horse Meat Act (41 Stat. 241; 21 optional ingredients in lieu of some but U.S.C. 96), in order to insure not all of the ingredients named in decharacterization of the product for paragraphs (a)(2), (b)(1)(i), and (c)(1) of human food purposes; this section, respectively, upon specific (iii) Certified pet food supplement approval of the Administrator. may contain various cereals, flours, [26 FR 3984, May 9, 1961, as amended at 29 FR vegetables, flavorings, seasonings and 9819, July 22, 1964; 29 FR 18419, Dec. 25, 1964. other processing aids acceptable to the Redesignated at 30 FR 4195, Mar. 31, 1965, and Administrator which shall be of good amended at 30 FR 10284, Aug. 19, 1965; 32 FR quality, shall be free from discolora- 13115, Sept. 15, 1967; 33 FR 6707, May 2, 1968] tion, mold, smut, and insect infestation, and shall be otherwise fit for use SUPERVISION as animal food; (iv) Certified pet food supplement § 355.31 Supervision by inspector. shall contain not less than 11 percent No container which bears or is to protein; bear a label as provided for under this (v) Certified pet food supplement part shall be filled in whole or in part shall contain not less than 3 percent except with certified products which fat; and have been inspected in compliance with (vi) Certified pet food supplement may not contain more than 74 percent this part, which are sound, healthful, moisture. wholesome, and otherwise fit for dogs, (c) Composition of canned certified vari- cats, and other carnivora, and which ety pet food. (1) Certified variety pet are strictly in accordance with the food shall contain not less than 25 per- statements on the label. No such con- cent of meat or animal food meat by- tainer shall be filled in whole or in part product or both, or of horse meat or and no such label shall be affixed there- animal food horse meat byproduct or to except under the supervision of an both, or of mule meat or animal food inspector. mule meat byproduct or both, or of poultry products. Upon specific ap-

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LABELING (6) When wheat flour or other processing aid is added to the product, § 355.32 Labeling required. there shall appear on the label, with Each container of inspected and cer- the name of the decharacterizing tified product shall have affixed there- agent, in predominating order, the to a label bearing the following infor- name of the processing aid, as, for ex- mation, prominently displayed: ample, ‘‘Wheat flour and bone added’’ (a) The name of the product, class of or ‘‘Bone and wheat flour added.’’ product, ingredient statement, and the (b) A statement of the quantity of animal foods inspection legend in the contents of the container, representing manner provided by paragraphs (a) (1), in terms of avoirdupois weight the (2), (3), (4), (5), and (6) of this section. quantity of product in the container. (1) The name of the canned or (c) The name and place of business of semimoist certified food shall include the manufacturer, packer, or distribu- words such as ‘‘dog food,’’ ‘‘cat food,’’ tor. The name under which inspection ‘‘dog and cat food,’’ or ‘‘fox food,’’ ac- is granted to a plant may appear with- companied with such references to op- out qualification on the label of a prod- tional ingredients as may be required uct prepared by that plant. When the by the Administrator under this part. certified product is not prepared by the Product names shall not be misleading person whose name appears on the in regard to class of canned or semi- label, the name shall be qualified by a moist certified food for which label is phrase which reveals the connection intended. such person has with the product as, (2) Class of product as outlined in for example, ‘‘Prepared for paragraphs (a), (b), and (c) of § 355.29 ——————————.’’ shall be declared on either the main [23 FR 10107, Dec. 23, 1958, as amended at 25 display or 20 percent panel of the label. FR 1357, Feb. 16, 1960; 26 FR 3984, May 9, 1961; (3) The word ‘‘ingredients,’’ followed 29 FR 9819, July 22, 1964. Redesignated at 30 by a complete list of ingredients of the FR 4195, Mar. 31, 1965, and amended at 32 FR food in the order of their predominance 13115, Sept. 15, 1967] and by their common or usual names, shall appear on the label with the name § 355.33 Plant number to be embossed of the food. on metal containers. (4) The inspection legend for canned, The official number assigned to an semi-moist or frozen certified animal inspected plant under § 355.8 shall be food shall appear on the label in the embossed on all sealed metal contain- form shown herewith, except that the ers of certified products filled in such plant number need not appear with the plant, except that such containers legend when such number is embossed which bear labels lithographed directly on the sealed metal container as pro- on the container and in which the vided in § 355.33. plant number is incorporated need not have the plant number embossed thereon. Labels and embossed code identification shall be affixed so as not to obscure the embossed plant number. [23 FR 10107, Dec. 23, 1958. Redesignated and amended at 30 FR 4195, Mar. 31, 1965; 32 FR 13115, Sept. 15, 1967; 38 FR 29215, Oct. 23, 1973]

§ 355.34 Labels, approval of, by Admin- (5) When a product is prepared in istrator. whole from any of the items defined in (a) Except as provided in paragraph § 355.2 (i) through (n), its name shall (c) of this section, no label shall be identify the item and there shall ap- used on any container of certified prod- pear contiguous to the name of the ucts until it has been approved by the item the name of the decharacterizing Administrator. For the convenience of agent used, followed by the word the inspected plant, sketches or proofs ‘‘added’’ as, for example, ‘‘bone added.’’ of proposed labels may be submitted in

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triplicate to the Administrator for ap- § 355.36 Obsolete labels. proval, and the preparation of the fin- At least once each year, each in- ished labels deferred until such ap- spected plant shall submit to the Ad- proval is obtained. All finished labels ministrator, in quadruplicate, a list of shall be submitted in quadruplicate to approvals for labels that have become the Administrator for approval. In the obsolete, accompanied by a statement case of lithographed labels, paper take- that such approvals are no longer de- offs in lieu of sections of the metal sired. The approvals shall be identified containers shall be submitted for ap- by the number, the date of approval, proval. Such paper take-offs shall not and the name of the product. be in the form of a negative but shall be a complete reproduction of the label § 355.37 Alteration or limitation of as it will appear on the package, in- statement of certification. cluding any color scheme involved. The statement of certification pro- (b) Inserts, tags, liners, pasters, and vided for by § 355.32(a)(4) shall not be al- like devices containing printed or tered, defaced, imitated, or simulated graphic matter for use on, or to be in any respect or used for the purpose placed within, containers and coverings of misrepresentation or deception. of certified products shall be submitted [25 FR 1357, Feb. 16, 1960. Redesignated at 30 for approval in the same manner as FR 4195, Mar. 31, 1965] provided for labels in paragraph (a) of this section, except that inspectors in PENALTIES charge may permit the use of such devices if they contain no reference to § 355.38 Withdrawal of service. the certified products and bear no mis- After opportunity for hearing before leading feature. a proper official of the Department has (c) Stencils, labels, box dies, and been accorded the operator of an in- brands may be used on shipping con- spected plant, the inspection, certifi- tainers, including tierces, barrels, cation, and identification provided for drums, boxes, crates, and large-size fi- in this part may be withdrawn from berboard containers, without approval such plant if the operator: (a) Persist- by the Administrator, provided the ently fails to comply with any provi- markings are applicable to the cer- sion of the regulations in this part or tified products, are not false or decep- of instructions or directions issued tive, and are used with the approval of thereunder; (b) makes any willful mis- the circuit supervisor. representation or engages in any fraud- (d) No certified product and no con- ulent or deceptive practice in connec- tainer thereof shall be labeled with any tion with the making of any application for service; (c) violates § 355.37; or false or deceptive term, and no state- (d) interferes with or obstructs any ment, word, picture, design, or device program employee in the performance which conveys any false impression or of his duties under the regulations in gives any false indication of the origin, this part by intimidation, threats, or quality, or quantity of the product other improper means. Pending final shall appear on any label. determination of the matter, the Ad- ministrator may suspend such inspec- § 355.35 Label information to be displayed on principal panel. tion, certification, and identification without hearing in cases of willfulness The label information required by or those in which the public health, in- § 355.32 shall be displayed on the prin- terest, or safety requires such action. cipal panel or panels of the label except The operator of the inspected plant that label information other than the shall be notified of the Administrator’s name of the product and the ingredient decision to suspend such inspection, statement may be displayed on a panel certification or identification service, immediately adjacent to the principal and the reasons therefor, in writing, in panel or panels if such supplemental the manner prescribed in § 1.147(b) of panel consists of at least 20 percent of the rules of practice (7 CFR 1.147(b)), or the label and is reserved exclusively for orally. The Administrator’s decision to required labeling information. suspend such inspection, certification

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or identification service shall be effec- mules about to be slaughtered for use tive upon such oral or written notifica- in the preparation of products under tion, whichever is earlier, to the opera- this part, before their slaughter shall tor of the plant. If such notification is be allowed for such use. Such inspec- oral, the Administrator shall confirm tion shall be made on the day of such decision and the reasons therefor, slaughter. in writing, as promptly as cir- (2) Mules found on such inspection to cumstances permit, and such written show symptoms of disease shall be set confirmation shall be served upon the apart and slaughtered separately. operator of the inspected plant, in the Those found to be affected with stran- manner prescribed in § 1.147(b) of the gles, purpura hemorrhagica, azoturia, rules of practice (7 CFR 1.147(b)). In infectious equine encephalomyelitis, other cases, prior to the institution of proceedings for any withdrawal or sus- toxic encephalomyelitis (forage poison- pension, the facts or conduct which ing), infectious anemia (swamp fever), may warrant such action shall be dourine, acute influenza, generalized called to the attention of the operator osteoporosis, glanders, farcy, or other in writing and he shall be given an op- malignant disorder, acute inflam- portunity to demonstrate or achieve matory lameness or extensive fistula, compliance with the requirements of shall be condemned and destroyed. Any the regulations in this part and in- mule which is suspected on ante- structions and directions issued there- mortem inspection of being infected under. with glanders shall be tested with mallein, and any mule which on phys- [23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, and amended at 43 FR ical examination is suspected of being 11148, Mar. 17, 1978] affected with dourine shall be held for further examination or for such test as APPEALS the Administrator may prescribe. (b)(1) A careful postmortem examina- § 355.39 Appeals from decisions made tion and inspection shall be made of all under this part. carcasses and parts thereof of all mules Any appeal from a decision by an em- inspected under this section, at the ployee of the Program shall be made to time of slaughter. All carcasses and his immediate superior having jurisdic- parts of mules found to be affected tion over the subject matter of the ap- with any disease listed under para- peal. graph (a) of this section shall be con- REPORTS demned and destroyed. (2) Other carcasses and parts of mules § 355.40 Plants to furnish information found abnormal or diseased upon infor reports. spection under this section shall be dis- Each day the operator of every in- posed of in accordance with such provi- spected plant shall furnish the inspec- sions of the Meat Inspection Regula- tor assigned to that plant with a state- tions (Subchapter A of this chapter) as ment of the number of pounds of prod- are deemed applicable by the Adminis- uct certified by the inspector. trator. (Approved by the Office of Management and Budget under control number 0583–0036) § 355.42 Marking of mule meat and animal food mule meat by-product. [23 FR 10107, Dec. 23, 1958. Redesignated at 30 FR 4195, Mar. 31, 1965, and amended at 47 FR All mule meat and animal food mule 746, Jan. 7, 1982] meat by-product inspected under this part shall be marked and identified as MULE MEAT AND ANIMAL FOOD, MULE the Administrator may require in any MEAT BY-PRODUCT particular case. § 355.41 Antemortem and postmortem [25 FR 1357, Feb. 16, 1960. Redesignated at 30 inspection for mules. FR 4195, Mar. 31, 1965, and amended at 32 FR (a)(1) An antemortem examination 13115, Sept. 15, 1967] and inspection shall be made of all

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§ 355.43 Scope and applicability of any human food product which is made rules of practice. wholly or in part from the carcass of The rules of practice of the Depart- any domesticated bird (chickens, tur- ment of Agriculture in subpart H of keys, ducks, geese, or guineas) and is part I, subtitle A, title 7 of the Code of excepted from the inspection require- Federal Regulations, are the rules of ments of the Poultry Products Inspec- practice applicable to adjudicatory, tion Act (21 U.S.C. 451 et seq.). admininstrative proceedings under the regulations in this part (9 CFR part § 362.2 Types and availability of service. 355). Upon application, in accordance with [43 FR 11148, Mar. 17, 1978] § 362.3, the following types of service may be furnished under the regulations PART 362—VOLUNTARY POULTRY in this part: INSPECTION REGULATIONS (a) Inspection service. An inspection and certification service for whole- Sec. someness relating to the slaughter and 362.1 Definitions. processing of poultry and the process- 362.2 Types and availability of service. ing of poultry products. All provisions 362.3 Application for service. 362.4 Denial or withdrawal of service. of subchapter C of this chapter shall 362.5 Fees and charges. apply to the slaughter of poultry, and the preparation, labeling, and certifi- AUTHORITY: 7 U.S.C. 1622, 1624; 7 CFR 2.17 cation of the poultry and poultry prod- (g) and (i), 2.55. ucts processed under this poultry in- SOURCE: 41 FR 23715, June 11, 1976, unless otherwise noted. spection service except for the following provisions: §§ 381.1(b)(2), 381.1(b)(5), § 362.1 Definitions. 381.1(b)(26), 381.1(b)(28), 381.1(b)(40), 381.1(b)(41), 381.1(b)(42), 381.1(b)(46), The definitions in § 381.1 are incor- 381.1(b)(56), 381.3(a), 381.6, 381.10, 381.13– porated in this part except for the defi- 381.17, 381.21, 381.29, 381.39–381.42, nitions found in §§ 381.1(b)(2), 381.1(b)(5), 381.1(b)(26), 381.1(b)(28), 381.1(b)(40), 381.175(a)(2), 381.175(a)(3), 381.179, 381.1(b)(41), 381.1(b)(42), 381.1(b)(46), and 381.185–381.187, 381.192, and 381.195– 381.1(b)(56) which are excluded in 381.225. § 362.2(a). In addition to those defini- (b) Export certification service. At tions, the following definitions will be the request of any person intending to applicable to the regulations in this export any slaughtered poultry or poul- part: try product, inspectors may make cer- (a) Act. ‘‘Act’’ means the Agricul- tification regarding products for tural Marketing Act of 1946, as amend- human food purposes, to be exported, ed (60 Stat. 1087, as amended; 7 U.S.C. as meeting conditions or standards 1621 et seq.). that are not imposed or are in addition (b) Inspector. ‘‘Inspector’’ means any to those imposed by the regulations in officer or employee of the Department part 381 of this chapter and the laws authorized to perform any duties under under which such regulations were is- the regulations in this part. sued. (c) Person. ‘‘Person’’ means any indi- (c) Identification Service. (1) Poultry vidual, corporation, company, associa- or other product that is federally in- tion, firm, partnership, society, or spected and passed at an official estab- joint stock company, or other orga- lishment, or upon importation, under nized business unit. the Poultry Products Inspection Act, is (d) Poultry. ‘‘Poultry’’ means any mi- officially marked to identify it as fed- gratory water fowl, game bird or squab, erally inspected and passed. In order to whether live or dead. facilitate the division of such poultry (e) Poultry product. ‘‘Poultry prod- or other product into smaller portions uct’’ means any poultry carcass or part or its combination into larger units thereof; or any human food product and still maintain its identity as prod- which is made wholly or in part from uct which has been federally inspected any poultry carcass or part thereof; or and passed and so marked, inspectors

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may supervise the handling and weigh- otherwise denied to, or withdrawn ing of the product and mark such por- from, any person who, or whose em- tions and units with the official mark ployee or agent in the scope of his em- of inspection when they determine that ployment or agency, (i) has willfully identity has been maintained. made any misrepresentation or has (2) At the time service is furnished, committed any other fraudulent or de- product must be sound, wholesome, and ceptive practice in connection with any fit for human food. The service will be application or request for service under available only on premises other than the regulations in this chapter; (ii) has those of an official establishment. The given or attempted to give, as a loan or sanitation of the place or area where for any other purpose, any money, service is furnished must comply with favor, or other thing of value, to any the provisions of part 381, subpart H, of employee of the Department author- this chapter. ized to perform any function under the (3) The mark of inspection shall be regulations in this chapter; (iii) has applied only under the immediate su- interfered with or obstructed, or at- pervision of an inspector. tempted to interfere with or to ob- (4) This service does not cover fur- struct, any employee of the Depart- ther cutting and processing of prod- ment in the performance of his duties ucts. These activities must take place under the regulations in this chapter at an official establishment. by intimidation, threats, assaults, (5) The registration and record- abuse, or any other improper means; keeping requirements enumerated in (iv) has knowingly falsely made, is- part 381, subpart Q, of this chapter sued, altered, forged, or counterfeited shall apply to persons requesting vol- any official certificate, memorandum, untary identification service under this mark, or other identification, or device paragraph (c). for making any such mark or identi- [41 FR 23715, June 11, 1976, as amended at 53 fication authorized or issued under this FR 3736, Feb. 9, 1988] chapter; (v) has knowingly uttered, published, or used as true any such § 362.3 Application for service. falsely made, issued, altered, forged, or Any person who desires to receive counterfeited certificate, memoran- service under the regulations in this dum, mark, identification, or device; part for poultry or other product eligi- (vi) has knowingly obtained or retained ble therefor under such regulations possession of any such falsely made, is- may make application for service to sued, altered, forged, or counterfeited the Administrator, upon an application certificate, memorandum, mark, iden- form which will be furnished by the Ad- tification, or device, or of any carcass ministrator upon request to the Meat or poultry or product bearing any such and Poultry Inspection Program, Food falsely made, issued, altered, forged or Safety and Inspection Service, U.S. De- counterfeited certificate, memoran- partment of Agriculture, Washington, dum, mark, or identification; (vii) has DC 20250. The application must include knowingly represented that any car- all the information called for by that cass, poultry, or product has been offi- form. In case of change of name, owner- cially inspected and passed (by an au- ship, management, or location, a new thorized inspector) under this chapter, application shall be made. when it had not in fact been so in- (Approved by the Office of Management and spected; (viii) has, within the previous Budget under control number 0583–0036) ten years, been convicted of any felony [41 FR 23715, June 11, 1976, as amended at 47 or more than one misdemeanor under FR 746, Jan. 7, 1982] any law based upon the acquiring, handling, or distributing of adulterated, § 362.4 Denial or withdrawal of serv- mislabeled, or deceptively packaged ice. food, or fraud in connection with trans- (a) For disciplinary reasons—(1) Bases actions in food, or any felony indicat- for denial or withdrawal. An application ing a lack of the integrity needed for or request for service may be rejected, the conduct of operations affecting the or the benefits of the service may be public health; (ix) has in any manner

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not specified in this paragraph violated graph, after notice and opportunity for subsection 203(h) of the Act: hearing before a proper official of the Provided, That paragraph (a)(1)(vi) of Department. The Administrator may this section shall not be deemed to be reject an application or request for violated if the person in possession of service or deny or withdraw service any item mentioned therein notifies under this paragraph without hearing, the inspector without delay that he has pending final determination of the possession of such item and, in the case matter, when he determines that the of an official device, surrenders it to public interest so requires. The opera- the inspector, and, in the case of any tor or applicant of such plant shall be other item, surrenders it to the inspec- notified of the Administrator’s deci- tor or destroys it or brings it into com- sion to reject the application or re- pliance with the regulations by obliter- quest for service or to deny or with- ating or removing the violative fea- draw such service, and the reasons tures under supervision of the inspec- therefor, in writing, in the manner pre- tor; And provided further, That an appli- scribed in § 1.147(b) of the rules of prac- cation or a request for service may be tice (7 CFR 1.147(b)), or orally. The Ad- rejected, or the benefits of the service ministrator’s decision to reject an ap- may be otherwise denied to, or with- plication or request for service or to drawn from any person who operates deny or withdraw the benefits of serv- an establishment for which he has ice under the Act shall be effective made application for service if, with upon such oral or written notification, the knowledge of such operator, any whichever is earlier, to the operator or other person conducting any oper- applicant of such plant. If such notifi- ations in such establishment has com- cation is oral, the Administrator shall mitted any of the offenses specified in confirm such decision, and the reasons paragraphs (a)(1) (i) through (ix) of this therefor, in writing, as promptly as cir- section after such application was cumstances permit, and such written made. Moreover, an application or a re- confirmation shall be served upon the quest for service made in the name of a operator or applicant of such plant in person otherwise eligible for service the manner prescribed in § 1.147(b) of under the regulations may be rejected, the rules of practice (7 CFR 1.147(b)). or the benefits of the service may be (b) For correctable cause—(1) Basis for otherwise denied to, or withdrawn denial or withdrawal. An application or from, such a person (a) in case the serv- request for service may be rejected, or ice is or would be performed at an es- the benefits of the service may be oth- tablishment operated (1) by a corpora- erwise denied to, or withdrawn from, tion, partnership, or other person from any person whose establishment does whom the benefits of the service are not meet the requirements as to prem- currently being withheld under this ises, facilities, and equipment, and the chapter, or (2) by a corporation, part- operation thereof, prescribed in the nership, or other person having an offi- regulations to prevent the distribution cer, director, partner, or substantial of adulterated poultry or poultry prod- investor from whom the benefits of ucts, or who has not received approval service under this chapter are cur- of labeling and containers to be used at rently being withheld and who has any the establishment as required by the authority with respect to the establish- regulations. ment where service is or would be per- (2) Procedure. An application or re- formed, or (b) in case the service is or quest for service may be rejected, or would be performed with respect to any benefits of the service may be other- poultry or product in which any cor- wise denied to or withdrawn by the poration, partnership, or other person Secretary, as provided by this para- within (a)(1) of this section has a con- graph, after notice and opportunity for tract or other financial interest. hearing before a proper official of the (2) Procedure. An application or re- Department. The Administrator may quest for service may be rejected, or reject an application or request for benefits of the service may be other- service or deny or withdraw service wise denied to or withdrawn by the under this paragraph without hearing, Secretary, as provided by this para- pending final determination of the

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matter, when he determines that the cation is oral, the person making such public interest so requires. The opera- decision shall confirm such decision, tor or applicant of such plant shall be and the reasons therefor, in writing, as notified of the Administrator’s deci- promptly as circumstances permit, and sion to reject the application or re- such written confirmation shall be quest for service or to deny or with- served upon the operator or applicant draw such service, and the reasons of such plant in the manner prescribed therefor, in writing, in the manner pre- in § 1.147(b) of the rules of practice (7 scribed in § 1.147(b) of the rules of prac- CFR 1.147(b)). tice (7 CFR 1.147(b)), or orally. The Ad- ministrator’s decision to reject an ap- (d) Scope and applicability of rules of plication or request for service or to practice. The rules of practice of the deny or withdraw the benefits of serv- Department of Agriculture in subpart ice under the Act shall be effective H of part I, subtitle A, title 7 of the upon such oral or written notification, Code of Federal Regulations, are the whichever is earlier, to the operator or rules of practice applicable to adjudica- applicant of such plant. If such notifi- tory, administrative proceedings under cation is oral, the Administrator shall the regulations in this part (9 CFR part confirm such decision, and the reasons 362). therefor, in writing, as promptly as circumstances permit, and such written [41 FR 23715, June 11, 1976, as amended at 43 FR 11148, Mar. 17, 1978] confirmation shall be served upon the operator or applicant of such plant in § 362.5 Fees and charges. the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)). (a) Fees and charges for service under (c) For miscellaneous reasons. An ap- the regulations in this part shall be plication or a request for service may paid by the applicant for the service in be rejected, or the benefits of the serv- accordance with this section, and, if re- ice may be otherwise denied to, or quired by the Administrator, the fees withdrawn from, any person, without a and charges shall be paid in advance. hearing, by the official in charge of the (b) The fees and charges provided for appropriate regional office, with the in this section shall be paid by check, concurrence of the Regional Director draft, or money order payable to the (1) for administrative reasons such as Treasurer of the United States and the nonavailability of personnel to per- shall be remitted promptly to the Ad- form the service; (2) for the failure to ministrator upon furnishing to the ap- pay for service; (3) in case the application or request relates to birds or prod- plicant a statement as to the amount ucts which are not eligible for service due. under this part 362; or (4) in case the (c) The fees to be charged and col- person is a partnership, corporation, or lected for service under the regulations other person from whom the benefits of in this part shall be at the rates speci- the service are currently being with- fied in §§ 391.2, 391.3, and 391.4 respec- held under paragraph (a) of this sec- tively for base time; for overtime in- tion. Notice of such rejection, denial, cluding Saturdays, Sundays, and holi- or withdrawal, and the reasons there- days; and for certain laboratory serv- for, shall promptly be given to the per- ices which are not covered under the son involved. The operator or applicant base time, overtime, and/or holiday of such plant shall be notified of such costs. Such fees shall cover the costs of decisions to reject an application or re- the services and shall be charged for quest for service or to deny or with- the time required to render such serv- draw the benefits of the service, and ice, including, but not limited to, the the reasons therefor, in writing, in the time required for the travel of the in- manner prescribed in § 1.147(b) of the spector or inspectors in connection rules of practice (7 CFR 1.147(b)), or orally. Such decision shall be effective therewith during the regularly sched- upon such oral or written notification, uled administrative workweek. whichever is earlier, to the operator or applicant of such plant. If such notifi-

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(d) Charges may also be made to nection with the furnishing of the serv- cover the cost of travel and other ex- ice. penses incurred by the Service in con- [41 FR 23715, June 11, 1976, as amended at 53 FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 1989]

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PART 381—POULTRY PRODUCTS Subpart F—Assignment and Authorities of INSPECTION REGULATIONS Program Employees; Appeals 381.30–381.31 [Reserved] Subpart A—Definitions 381.32 Access to establishments. Sec. 381.33 Identification. 381.1 Definitions. 381.34 Financial interest of inspectors. 381.35 Appeal inspections; how made. Subpart B—Administration; Application of Inspection and Other Requirements Subpart G—Facilities for Inspection; Over- time and Holiday Service; Billing Es- 381.3 Administration. tablishments 381.4 Inspection in accordance with methods prescribed or approved. 381.36 Facilities required. 381.5 Publications. 381.37 Schedule of operations. 381.6 Establishments requiring inspection. 381.38 Overtime and holiday inspection serv- 381.7 Coverage of all poultry and poultry ice. products processed in official establish- 381.39 Bases of billing for overtime and holi- ments. day services.

Subpart C—Exemptions Subpart H—Sanitation

381.10 Exemptions for specified operations. 381.45 Minimum standards for sanitation, 381.11 Exemptions based on religious die- facilities, and operating procedures in of- tary laws. ficial establishments. 381.12 Effect of religious dietary laws ex- 381.46 Buildings. emptions on other persons. 381.47 Rooms and compartments. 381.13 Suspension or termination of exemp- 381.48 Floors, walls, ceilings, etc. tions. 381.14 Inspection concerning purportedly ex- 381.49 Drainage and plumbing. empted operations. 381.50 Water supply. 381.15 Exemption from definition of ‘‘poul- 381.51 Lavatories, toilets, and other sani- try product’’ of certain human food prod- tary facilities. ucts containing poultry. 381.52 Lighting and ventilation. 381.53 Equipment and utensils. Subpart D—Application for Inspection; 381.54 Accessibility of equipment. Grant or Refusal of Inspection 381.55 Restrictions on use of equipment and utensils. 381.16 How application shall be made. 381.56 Maintenance of sanitary conditions 381.17 Filing of application. and precautions against contamination 381.18 Authority of applicant. of poultry products; PCB-containing 381.19 Application for inspection; required equipment. facilities. 381.57 Cleaning of rooms and compartments. 381.20 Survey and grant of inspection. 381.58 Cleaning of equipment and utensils. 381.21 Refusal of inspection. 381.59 Vermin. 381.22 Conditions for receiving inspection. 381.60 Use of compounds. Subpart E—Inauguration of Inspection; Of- 381.61 Cleanliness and hygiene of official es- ficial Establishment Numbers; Separa- tablishment personnel. tion of Establishments and Other Re- Subpart I—Operating Procedures quirements; Withdrawal of Inspection 381.65 Operations and procedures, generally. 381.25 Official establishment numbers. 381.66 Temperatures and chilling and freez- 381.26 Separation of establishments. ing procedures. 381.27 Inauguration of service; notification concerning regulations; status of 381.67 Young chicken slaughter inspection uninspected poultry products. rate maximums under traditional inspec- 381.28 Report of violations. tion procedure. 381.29 Suspension or other withdrawal of in- 381.68 Maximum inspection rates—New tur- spection service. key inspection system.

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Subpart J—Ante Mortem Inspection 381.104 Official export certificates, marks and devices. 381.70 Ante mortem inspection; when re- 381.105 Export certification; marking of quired; extent. containers. 381.71 Condemnation on ante mortem in- 381.106 Form of official export certificate. spection. 381.107 Special procedures as to certifi- 381.72 Segregation of suspects on ante cation of poultry products for export to mortem inspection. certain countries. 381.73 Quarantine of diseased poultry. 381.108 Official poultry inspection certifi- 381.74 Poultry suspected of having biologi- cates; issuance and disposition. cal residues. 381.109 Form of official poultry inspection 381.75 Poultry used for research. certificate. 381.110 Erasures or alterations made on cer- Subpart K—Post Mortem Inspection; tificates. Disposition of Carcasses and Parts 381.111 Data to be entered in proper spaces. 381.112 Official mark for maintaining the 381.76 Post-mortem inspection, when re- identity and integrity of samples. quired; extent; traditional, Streamlined Inspection System (SIS), New Line Speed Subpart N—Labeling and Containers (NELS) Inspection System and the New Turkey Inspection (NTI) System; rate of 381.115 Containers of inspected and passed inspection. poultry products required to be labeled. 381.77 Carcasses held for further examina- 381.116 Wording on labels of immediate con- tion. tainers. 381.78 Condemnation of carcasses and parts: 381.117 Name of product and other labeling. separation of poultry suspected of con- 381.118 Ingredients statement. taining biological residues. 381.119 Declaration of artificial flavoring or 381.79 Passing of carcasses and parts. coloring. 381.80 General; biological residues. 381.120 Antioxidants; chemical preserva- 381.81 Tuberculosis. tives; and other additives. 381.82 Diseases of the leukosis complex. 381.121 Quantity of contents. 381.83 Septicemia or toxemia. 381.121a Quantity of contents labeling. 381.84 Airsacculitis. 381.121b Definitions and procedures for de- 381.85 Special diseases. termining net weight compliance. 381.86 Inflammatory processes. 381.121c Scale requirements for accurate 381.87 Tumors. weights, repairs, adjustments, and re- 381.88 Parasites. placement after inspection. 381.89 Bruises. 381.121d Scales; testing of. 381.90 Cadavers. 381.121e Handling of failed product. 381.91 Contamination. 381.122 Identification of manufacturer, 381.92 Overscald. packer or distributor. 381.93 Decomposition. 381.123 Official inspection mark; official es- 381.94 Contamination with Microorganisms; tablishment number. process control verification criteria and 381.124 Dietary food claims. testing; pathogen reduction standards. 381.125 Special handling label requirements. 381.126 Date of packing and date of process- Subpart L—Handling and Disposal of Con- ing; contents of cans. demned or Other Inedible Products at 381.127 Wording on labels of shipping con- Official Establishments tainers. 381.128 Labels in foreign languages. 381.95 Disposal of condemned poultry prod- 381.129 False or misleading labeling or con- ucts. tainers. 381.130 False or misleading labeling or con- Subpart M—Official Marks, Devices and tainers; orders to withhold from use. Certificates; Export Certificates; Certifi- 381.131 Preparation of labeling or other de- cation Procedures vices bearing official inspection marks without advance approval prohibited; ex- 381.96 Wording and form of the official in- ceptions. spection legend. 381.132 Labeling approval. 381.97 [Reserved] 381.133 Generically approved labeling. 381.98 Official seal. 381.134 Requirement of formulas. 381.99 Official retention and rejection tags. 381.135 Irradiated poultry product. 381.100 Official detention tag. 381.136 Affixing of official identification. 381.101 Official U.S. Condemned mark. 381.137 Evidence of labeling and devices ap- 381.102 [Reserved] proval. 381.103 Official poultry condemnation cer- 381.138 Unauthorized use or disposition of tificates; issuance and form. approved labeling or devices.

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381.139 Removal of official identifications. Subpart Q—Records, Registration, and 381.140 Relabeling poultry products. Reports 381.141–381.143 [Reserved] 381.144 Packaging materials. 381.175 Records required to be kept. 381.176 Place of maintenance of records. Subpart O—Entry of Articles Into Official Es- 381.177 Record retention period. tablishments; Processing Inspection 381.178 Access to and inspection of records, and Other Reinspections; Processing facilities and inventory; copying and Requirements sampling. 381.179 Registration. 381.145 Poultry products and other articles 381.180 Information and reports required entering or at official establishments; from official establishment operators. examination and other requirements. 381.181 Reports by consignees of allegedly 381.146 Sampling at official establishments. adulterated or misbranded products; sale 381.147 Restrictions on the use of substances or transportation as violations. in poultry products. 381.182 Reports of inspection work. 381.148 Processing and handling requirements for frozen poultry products. Subpart R—Cooperation With States and 381.149 Irradiation of poultry product to Territories; Certification of State and control foodborne pathogens. Territorial Programs as at Least Equal 381.150 Requirements for the production of to Federal Program poultry breakfast strips, poultry rolls, and certain other poultry products. 381.185 Assistance to State and Territorial 381.151 Adulteration of product by polluted programs. water; procedure for handling. 381.186 Cooperation of States and other jurisdictions in Federal programs. 381.152 Preparation in an official establishment of articles not for human food. 381.153 Accreditation of chemistry labora- Subpart S—Transportation; Exportation; or tories. Sale of Poultry or Poultry Products 381.189 Provisions inapplicable to specimens Subpart P—Definitions and Standards of for laboratory examination, etc., or to Identity or Composition naturally inedible articles. 381.190 Transactions in slaughtered poultry 381.155 General. and other poultry products restricted; 381.156 Poultry meat content standards for vehicle sanitation requirements. certain poultry products. 381.191 Distribution of inspected products to 381.157 Canned boned poultry and baby or small lot buyers. geriatric food. 381.192 Penalties inapplicable to carriers. 381.158 Poultry dinners (frozen) and pies. 381.193 Poultry carcasses, etc., not intended 381.159 Poultry rolls. for human food. 381.160 (Kind) burgers; (Kind) patties. 381.194 Transportation and other trans- 381.161 (Kind) A La Kiev. actions concerning dead, dying, disabled, 381.162 ‘‘(Kind) steak or fillet.’’ or diseased poultry, and parts of car- 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) roasted.’’ casses of poultry that died otherwise 381.164 ‘‘(Kind) barbecued.’’ than by slaughter. 381.165 ‘‘(Kind) barbecued prepared with moist heat.’’ Subpart T—Imported Poultry Products 381.166 Breaded products. 381.195 Definitions; requirements for impor- 381.167 Other poultry dishes and specialty tation into the United States. items. 381.196 Eligibility of foreign countries for 381.168 Maximum percent of skin in certain importation of poultry products into the poultry products. United States. 381.169 Ready-to-cook poultry products to 381.197 Imported products; foreign inspec- which solutions are added. tion certificates required. 381.170 Standards for kinds and classes, and 381.198 Importer to make application for infor cuts of raw poultry. spection of poultry products offered for 381.171 Definition and standard for ‘‘Turkey entry. Ham.’’ 381.199 Inspection of poultry products of- 381.173 Mechanically Separated (Kind of fered for entry. Poultry). 381.200 Poultry products offered for entry, 381.174 Limitations with respect to use of retention in customs custody; delivery Mechanically Separated (Kind of Poul- under bond; movement prior to inspec- try). tion; handling; facilities and assistance.

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381.201 Means of conveyance and equipment 381.222 States designated under paragraph used in handling poultry products offered 5(c) of the Act; application of regula- for entry to be maintained in sanitary tions. condition. 381.223 Control and disposition of nonfed- 381.202 Poultry products offered for entry; erally inspected poultry products in reporting of findings to customs; han- States designated under paragraph 5(c) of dling of articles refused entry; appeals, the Act. how made; denaturing procedures. 381.224 Designation of States under section 381.203 Products offered for entry; charges 11 of the Act; application of sections of for storage, cartage, and labor with re- the Act and the regulations. spect to products which are refused 381.225 Criteria and procedure for designat- entry. ing establishments with operations 381.204 Marking of poultry products offered which would clearly endanger the public for entry; official import inspection health; disposition of poultry products marks and devices. therein. 381.205 Labeling of immediate containers of Subpart W—Rules of Practice Governing poultry products offered for entry. 381.206 Labeling of shipping containers of Proceedings Under the Poultry Prod- poultry products offered for entry. ucts Inspection Act 381.207 Small importations for consignee’s GENERAL personal use, display, or laboratory analysis. 381.230 Scope and applicability of rules of 381.208 Poultry products offered for entry practice. and entered to be handled and trans- SUPPLEMENTAL RULES OF PRACTICE ported as domestic; entry into official establishments; transportation. 381.231 Refusal or withdrawal of inspection 381.209 Returned United States inspected service under section 18(a) of the Act. and marked poultry products: exemption. 381.232 Withdrawal of inspection service for failure of an establishment to destroy Subpart U—Detention; Seizure and any condemned carcass or part thereof or Condemnation; Criminal Offenses any condemned poultry product. 381.233 Withholding use of marking, label- 381.210 Poultry and other articles subject to ing or containers from use under section administrative detention. 8 of the Poultry Products Inspection Act. 381.211 Method of detention; form of deten- 381.234 Refusal or withdrawal of inspection tion tag. service under the Poultry Products In- spection Act for failure to comply with 381.212 Notification of detention to the requirements as to premises, facilities, owner of the poultry or other article, or equipment, or the operation thereof. the owner’s agent, and person having custody. RULES APPLICABLE TO THE SUSPENSION OF THE 381.213 Notification of governmental au- ASSIGNMENT OF INSPECTORS FOR THREATS thorities having jurisdiction over article TO FORCIBLY ASSAULT OR FORCIBLE AS- detained; form of written notification. SAULT, INTIMIDATION OR INTERFERENCE 381.214 Movement of poultry or other article WITH ANY INSPECTION SERVICE EMPLOYEE detained; removal of official marks. 381.235 Notification to operator of establish- 381.215 Poultry or other articles subject to ment of incident. judicial seizure and condemnation. 381.236 Procedure upon failure of operator of 381.216 Procedure for judicial seizure, con- establishment to take action required by demnation, and disposition. § 381.29 of the regulations. 381.217 Authority for condemnation or seizure under other provisions of law. Subpart X—Canning and Canned Products 381.218 Criminal offenses. 381.300 Definitions. Subpart V—Special Provisions for Des- 381.301 Containers and closures. ignated States and Territories; Criteria 381.302 Thermal processing. and Procedure for Designating Estab- 381.303 Critical factors and the application of the process schedule. lishments With Operations Which 381.304 Operations in the thermal processing Would Clearly Endanger the Public area. Health; Disposition of Poultry Products 381.305 Equipment and procedures for heat Therein processing systems. 381.306 Processing and production records. 381.220 Definition of ‘‘State’’. 381.307 Record review and maintenance. 381.221 Designation of States under para- 381.308 Deviations in processing. graph 5(c) of the Act. 381.309 Finished product inspection.

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381.310 Personnel and training. (b) For the purposes of such regula- 381.311 Recall procedure. tions, unless otherwise required by the context, the following terms shall be Subpart Y—Nutrition Labeling construed, respectively, to mean: 381.400 Nutrition labeling of poultry prod- (1) Acceptable. ‘‘Acceptable’’ means ucts. suitable for the purpose intended and 381.401 [Reserved] acceptable to the Administrator. 381.402 Location of nutrition information. (2) Act. ‘‘Act’’ means the Poultry 381.403–381.407 [Reserved] Products Inspection Act (71 Stat. 441, 381.408 Labeling of poultry products with as amended by the Wholesome Poultry number of servings. Products Act, 82 Stat. 791; 21 U.S.C. 451 381.409 Nutrition label content. 381.410–381.411 [Reserved] et seq.). 381.412 Reference amounts customarily (3) Administrator. ‘‘Administrator’’ consumed per eating occasion. means the Administrator of the Food 381.413 Nutrient content claims; general Safety and Inspection Service of the principles. Department or any other officer or em- 381.414–381.442 [Reserved] ployee of the Department to whom 381.443 Significant participation for vol- there has heretofore been delegated, or untary nutrition labeling. to whom there may hereafter be dele- 381.444 Identification of major cuts of poul- gated the authority to act in his stead. try products. 381.445 Guidelines for voluntary nutrition (4) Adulterated. ‘‘Adulterated’’ applies labeling of single-ingredient, raw prod- to any poultry product under one or ucts. more of the following circumstances: 381.446–381.453 [Reserved] (i) If it bears or contains any poison- 381.454 Nutrient content claims for ‘‘good ous or deleterious substance which source,’’ ‘‘high,’’ and ‘‘more’’. may render it injurious to health; but 381.455 [Reserved] in case the substance is not an added 381.456 Nutrient content claims for ‘‘light’’ substance, such article shall not be or ‘‘lite’’. considered adulterated under this 381.457–381.459 [Reserved] 381.460 Nutrient content claims for calorie clause if the quantity of such sub- content. stance in or on such article does not 381.461 Nutrient content claims for the so- ordinarily render it injurious to health; dium content. (ii)(a) If it bears or contains (by rea- 381.462 Nutrient content claims for fat, son of administration of any substance fatty acids, and cholesterol content. to the live poultry or otherwise) any 381.463 Nutrient content claims for added poisonous or added deleterious ‘‘healthy.’’ substance (other than one which is a 381.464–381.468 [Reserved] 381.469 Labeling applications for nutrient pesticide chemical in or on a raw agri- content claims. cultural commodity; a food additive; or 381.470–381.479 [Reserved] a color additive) which may, in the 381.480 Label statements relating to useful- judgment of the Administrator, make ness in reducing or maintaining body such article unfit for human food; weight. (b) If it is, in whole or part, a raw ag- 381.481–381.499 [Reserved] ricultural commodity and such com- 381.500 Exemption from nutrition labeling. modity bears or contains a pesticide AUTHORITY: 7 U.S.C. 138f, 450; 21 U.S.C. 451– chemical which is unsafe within the 470; 7 CFR 2.18, 2.53. meaning of section 408 of the Federal SOURCE: 37 FR 9706, May 16, 1972, unless Food, Drug, and Cosmetic Act; otherwise noted. (c) If it bears or contains any food additive which is unsafe within the mean- Subpart A—Definitions ing of section 409 of the Federal Food, Drug, and Cosmetic Act; § 381.1 Definitions. (d) If it bears or contains any color (a) For the purposes of the regula- additive which is unsafe within the tions in this part, unless otherwise re- meaning of section 706 of the Federal quired by the context, the singular Food, Drug, and Cosmetic Act: form shall also import the plural and Provided, That an article which is not the masculine form shall also import otherwise deemed adulterated under the feminine, and vice versa. paragraphs (b)(4)(ii) (b), (c), or (d) of

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this section shall nevertheless be growth promoter, antibiotic, anthel- deemed adulterated if use of the pes- mintic, tranquilizer, or other agent ticide chemical, food additive, or color that leaves a residue. additive in or on such article is prohib- (8) Capable of use as human food. The ited by the regulations in this part in term ‘‘capable of use as human food’’ official establishments; applies to any carcass, or part or prod- (iii) If it consists in whole or in part uct of a carcass of any poultry, unless of any filthy, putrid, or decomposed it is denatured or otherwise identified substance or is for any other reason as required by the regulations, or it is unsound, unhealthful, unwholesome, or naturally inedible by humans. otherwise unfit for human food; (9) Carcass. This term means all (iv) If it has been prepared, packed, parts, including viscera, of any slaugh- or held under insanitary conditions tered poultry. whereby it may have become contami- (10) Commerce. ‘‘Commerce’’ means nated with filth, or whereby it may commerce between any State, any ter- have been rendered injurious to health; ritory, or the District of Columbia, and (v) If it is, in whole or in part, the any place outside thereof; or within product of any poultry which has died any territory not organized with a leg- otherwise than by slaughter; islative body, or the District of Colum- (vi) If its container is composed, in bia. whole or in part, of any poisonous or (11) Consumer package. ‘‘Consumer deleterious substance which may package’’ means any container in render the contents injurious to which a poultry product is enclosed for health; the purpose of display and sale to (vii) If it has been intentionally sub- household consumers. jected to radiation, unless the use of (12) Container. The term ‘‘container’’ the radiation was in conformity with a includes any box, can, tin, cloth, plas- regulation or exemption in effect pur- tic, or any other receptacle, wrapper, suant to section 409 of the Federal or cover. Food, Drug, and Cosmetic Act; or (13) Department. ‘‘Department’’ means (viii) If any valuable constituent has the United States Department of Agri- been in whole or in part omitted or ab- culture. stracted therefrom; or if any substance (14)–(15) [Reserved] has been substituted, wholly or in part (16) Edible. This term means that an therefor; or if damage or inferiority article is intended for use as human has been concealed in any manner; or if food. any substance has been added thereto (17) Egg Products Inspection Act. ‘‘Egg or mixed or packed therewith so as to Products Inspection Act’’ means the increase its bulk or weight, or reduce Act so entitled, approved December 29, its quality or strength, or make it ap- 1970 (84 Stat. 1620, 21 U.S.C. 1031 et pear better or of greater value than it seq.). is. (18) Federal Food, Drug, and Cosmetic (5) Animal food manufacturer. ‘‘Animal Act. ‘‘Federal Food, Drug, and Cos- Food Manufacturer’’ means any person metic Act’’ means the Act so entitled, engaged in the business of manufactur- approved June 25, 1938 (52 Stat. 1040), ing or processing animal food. and acts amendatory thereof or supple- (6) Applicant. ‘‘Applicant’’ means any mentary thereto (21 U.S.C. 301 et seq.). person who requests inspection service, (19) Federal Meat Inspection Act. ‘‘Fed- exemption, or other authorization eral Meat Inspection Act’’ means the under the regulations. Act so entitled, approved March 4, 1907, (7) Biological residue. ‘‘Biological Res- 34 Stat. 1260, as amended by the Whole- idue’’ means any substance, including some Meat Act, 81 Stat. 584 (21 U.S.C. metabolites, remaining in poultry at 601 et seq.). the time of slaughter or in any of its (20) Free from protruding pinfeathers. tissues after slaughter, as the result of ‘‘Free from protruding pinfeathers’’ treatment or exposure of the live poul- means that the carcass is free from try to a pesticide, organic compound, protruding pinfeathers which are visi- metallic or other inorganic compound, ble to an inspector during an examina- hormone, hormone-like substance, tion of the carcass at normal operating

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speeds. However, a carcass may be con- (28)(i) Inspector. ‘‘Inspector’’ means sidered as being free from protruding (a) an employee or official of the U.S. pinfeathers if it has a generally clean Government authorized by the Admin- appearance (especially on the breast), istrator to inspect poultry and poultry and if not more than an occasional pro- products under the authority of this truding pinfeather is in evidence dur- Act, or (b) any employee or official of ing a more careful examination of the the government of any State or Terri- carcass. tory or the District of Columbia au- (21) Giblets. ‘‘Giblets’’ means the liver thorized by the Administrator to in- from which the bile sac has been respect poultry and poultry products moved, the heart from which the peri- under the authority of this Act, under cardial sac has been removed, and the an agreement entered into between the gizzard from which the lining and con- Administrator and the appropriate tents have been removed: Provided, State or other agency. That each such organ has been prop- (ii) Inspector in Charge. This term erly trimmed and washed. means the inspector primarily respon- (22) Immediate container. ‘‘Immediate sible for the conduct of inspection at container’’ includes any consumer any particular official establishment. package; or any other container in (29) Label. This term applies to any which poultry products, not consumer display of written, printed, or graphic packaged, are packed. matter upon any article or the imme- (23) Inedible. This term means any diate container (not including package carcass or any part of a carcass that is liners) of any article. either naturally inedible by humans or (30) Labeling. This term applies to all is rendered unfit for human food by labels and other written, printed, or reason of adulteration or denaturing. graphic matter (i) upon any article or (24) Inspected for wholesomeness. This any of its containers or wrappers, or term means that the poultry product (ii) accompanying such article. so identified has been inspected and (31) Misbranded. This term applies to was found at the time of such inspec- any poultry product under one or more tion to be not adulterated. of the following circumstances: (25) Inspection. ‘‘Inspection’’ means (i) If its labeling is false or mislead- any inspection required by the regula- ing in any particular; tions to determine whether any poul- (ii) If it is offered for sale under the try or poultry products comply with name of another food; the requirements of the Act and the (iii) If it is an imitation of another regulations. food, unless its label bears, in type of (26) Inspection Service. ‘‘Inspection uniform size and prominence, the word Service’’ means the organizational unit ‘‘imitation’’ and immediately there- within the Department having the re- after, the name of the food imitated; sponsibility for carrying out the provi- (iv) If its container is so made, sions of the Act. formed, or filled as to be misleading; (27)(i) Inspection Service employee. This term refers to any employee of (v) If in a package or other container, the Inspection Service who is author- unless it bears a label showing: ized to perform any function under the (a) The name and place of business of regulations. the manufacturer, packer, or distribu- (ii) Inspection Service supervisor. This tor; and term refers to any employee of the In- (b) An accurate statement of the spection Service who is delegated au- quantity of the contents in terms of thority to exercise supervision over weight, measure, or numerical count; certain phases of the inspection pro- except as otherwise provided in gram at a designated level. 1 § 381.121(a) with respect to the quantity of contents; (vi) If any word, statement, or other 1 Information identifying the employees information required by or under au- who have been delegated such authority at various levels may be obtained from an in- thority of the Act to appear on the spector or from the Administrator, Food label or other labeling is not promi- Safety and Inspection Service, U.S. Depart- nently placed thereon with such con- ment of Agriculture, Washington, DC 20250. spicuousness (as compared with other

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words, statements, designs, or devices, product was processed; and unre- in the labeling) and in such terms as to stricted by any of the foregoing; such render it likely to be read and under- other information as the Adminis- stood by the ordinary individual under trator may require in the regulations customary conditions of purchase and to assure that it will not have false or use; misleading labeling and that the public (vii) If it purports to be or is rep- will be informed of the manner of han- resented as a food for which a defini- dling required to maintain the article tion and standard of identity or com- in a wholesome condition. position is prescribed by the regula- (32) Nonfood compounds. Any sub- tions in subpart P of this part unless: stance proposed for use in official es- (a) It conforms to such definition and tablishments, the intended use of standard, and which will not result, directly or indi- (b) Its label bears the name of the rectly, in the substance becoming a food specified in the definition and component or otherwise affecting the standard, and insofar as may be re- characteristics of poultry or poultry quired by such regulations, the com- products, excluding labeling and pack- mon names of optional ingredients aging materials as covered in subpart (other than spices, flavoring, and color- N of this part. ing) present in such food. (33) Official establishment. ‘‘Official es- (viii) If it purports to be or is rep- tablishment’’ means any establishment resented as a food for which a standard as determined by the Administrator at or standards of fill of container have which inspection of the slaughter of been prescribed by regulations of the poultry, or the processing of poultry Secretary, 2 and falls below the stand- products, is maintained pursuant to ard of fill of container applicable there- the regulations. to, unless its label bears, in such man- (34) Official mark. This term means ner and form as such regulations speci- any symbol prescribed in subpart M of fy, a statement that it falls below such this part to identify the status of any standard; article or poultry under the Act. (ix) If it is not subject to the provi- (35) Official inspection legend. This sions of paragraph (b)(31)(vii) of this term means the official inspection section, unless its label bears: mark prescribed in § 381.96 or the offi- (a) The common or usual name of the cial poultry identification mark pre- food, if any there be, and scribed in § 381.97, showing that an arti- (b) In case it is fabricated from two cle was inspected for wholesomeness or more ingredients, the common or and passed in accordance with the Act. usual name of each ingredient, except (36) Official certificate. This term as otherwise provided in § 381.118(c); means any certificate prescribed in (x) If it purports to be or is rep- subpart M of this part relating to poul- resented for special dietary uses, unless try or poultry products. the label bears such information con- (37) Official device. This term means cerning its vitamin, mineral, and other any label or other device prescribed in dietary properties as is required by subpart M of this part for use in apply- § 381.124; ing any official mark. (xi) If it bears or contains any artifi- (38) Pesticide chemical, food additive, cial flavoring, artificial coloring, or color additive, raw agricultural commod- chemical preservative, unless it bears a ity. These terms shall have the same label stating that fact; except as other- meanings for the purposes of the Act wise provided in § 381.119, or and the regulations as under the Fed- (xii) If it fails to bear, directly there- eral Food, Drug, and Cosmetic Act. on or on its containers, when required (39) Potable water. ‘‘Potable water’’ by § 381.123, the official inspection leg- means water that has been approved by end and the official establishment the State health authority or other number of the establishment where the agency or laboratory acceptable to the Administrator as safe for drinking and 2 No such standards are currently in effect. suitable for food processing. However, § 381.129 prohibits the use of false or (40) Poultry. ‘‘Poultry’’ means any do- misleading containers. mesticated bird (chickens, turkeys,

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ducks, geese, or guineas), whether live suitable for cooking without need of or dead. further processing. (41) Poultry product. (i) This term (45) Regulations. ‘‘Regulations’’ means any poultry carcass or part means the provisions of this entire thereof; or any product which is made part. wholly or in part from any poultry car- (46) Renderer. ‘‘Renderer’’ means any cass or part thereof, excepting those person engaged in the business of ren- exempted from definition as a poultry dering carcasses, or parts or products product in § 381.15. Except where the of the carcasses, of poultry, except ren- context requires otherwise (e.g., in dering conducted under inspection or paragraph (b)(42) of this section), this exemption pursuant to the regulations. term is limited to articles capable of (47) Secretary. ‘‘Secretary’’ means the use as human food. Secretary of Agriculture of the United (ii) Poultry food product. This term States or his delegate. means any product capable of use as (48) Shipping container. ‘‘Shipping human food which is made in part from container’’ means any container used any poultry carcass or part thereof, ex- or intended for use in packaging the cepting those exempted from definition product packed in an immediate con- as a poultry product in § 381.15. tainer. (42) Poultry products broker. ‘‘Poultry (49) Slaughter. ‘‘Slaughter’’ means the products broker’’ means any person enact of killing poultry for human food. gaged in the business of buying or sell- (50) State. Except as otherwise pro- ing poultry products on commission, or vided in § 381.220 ‘‘State’’ means any otherwise negotiating purchases or State of the United States and the sales of such articles other than for his Commonwealth of Puerto Rico. own account or as an employee of an- (51)(i) Supervision. This term means other person. the controls, as prescribed in instruc- (43) Process. Process used as a verb tions to Inspection Service employees, means to conduct any operation or to be exercised by them over particular combination of operations, whereby operations to insure that such oper- poultry is slaughtered, eviscerated, ations are conducted in compliance canned, salted, stuffed, rendered, with the Act and the regulations in boned, cut up, or otherwise manufac- this part. tured or processed. The term ‘‘process’’ does not refer to freezing of poultry (ii) Circuit supervisor. This term refers products, except when freezing is inci- to the official of the Inspection Service dental to operations otherwise classed who is assigned responsibility for su- as ‘‘processing’’ under this paragraph. pervising the conduct of inspection at a specific group of official establish- (44) Ready-to-cook poultry. ‘‘Ready- to-cook poultry’’ means any slaugh- ments. tered poultry free from protruding pin- (52) Territory. The term ‘‘territory’’ feathers, vestigial feathers (hair or means Guam, the Virgin Islands of the down as the case may be) and from United States, American Samoa, and which the head, feet, crop, oil gland, any other territory or possession of the trachea, esophagus, entrails, mature United States, excluding the Canal reproductive organs, and lungs have Zone. been removed, and in the case of cer- (53) United States. This term means tain mature poultry, as defined in the States, the District of Columbia, § 381.170(a) (1)(vi), (vii) and (2)(iv), the and the territories of the United kidneys have been removed in accord- States. ance with the requirements of (54) U.S. Detained. This term is appli- § 381.65(d), and with or without the gib- cable to poultry, poultry products, and lets, and which is suitable for cooking other articles which are held in official without need of further processing. custody in accordance with section 19 Ready-to-cook poultry also means any of the Act and § 381.210, pending dis- cut-up or disjointed portion of poultry posal as provided in said section 19. or other parts of poultry such as repro- (55) U.S. Condemned. This term means ductive organs, head, or feet that are that the poultry carcass, or part or

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product of a poultry carcass, so identi- IFO #6. Miami, FL—Covering the areas of fied was inspected and found to be southern Florida, Puerto Rico and the Virgin adulterated and is condemned. Islands. (56) U.S. Refused Entry. This term IFO #7. New Orleans, LA—Covering the means that the slaughtered poultry or States of Louisiana, Mississippi, Alabama, Arkansas, Texas, Oklahoma, Kansas, New other poultry product so identified was Mexico and Colorado. presented for inspection for entry into IFO #8. San Pedro, CA—Covering the the United States and was found not to States of Hawaii, Arizona, Utah, Nevada, the comply with the requirements of the area of southern California, American Act. Samoa, Guam, and the Northern Marianas. (57) U.S. Rejected. This term means IFO #9. Tacoma, WA—Covering the States that the equipment or facility so iden- of Washington, Oregon, Idaho, Montana, Wy- tified is prohibited from being used in oming, North Dakota, South Dakota, Alas- the processing of any poultry or poul- ka, and Nebraska, and the area of northern California. try product until such equipment or fa- IFO #10. Detroit, MI—Covering the States cility is found by an inspector to be of Michigan, Wisconsin, Minnesota, Iowa, sanitary and otherwise eligible for use Missouri, Illinois, Indiana and Ohio. under the regulations. (62) Import Supervisor. The official in (58) U.S. Retained. This term means charge of import inspection activities that the poultry or carcass, or part or within each of the import field offices. product of a carcass, of poultry so iden- (c) For the purposes of the standard tified is held at an official establish- for cooked, smoked sausage (§ 319.180 of ment by the inspection service for fur- this chapter), the term ‘‘poultry by- ther determination as to its disposal. product’’ means the skin, fat, gizzard, (59) Packaging material. Any cloth, heart, or liver, or any combination paper, plastic, metal, or other material thereof, of any poultry. used to form a container, wrapper, label, or cover for poultry products. [37 FR 9706; May 16, 1972, as amended at 39 (60) Animal food. Any article intended FR 4568, Feb. 5, 1974; 40 FR 42338, Sept. 12, for use as food for dogs, cats, or other 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. animals, derived wholly, or in part, 19, 1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Dec. 5, 1984; 51 FR 37709, Oct. 24, 1986] from carcasses or parts or products of the carcass of poultry, except that the term animal food as used herein does Subpart B—Administration; Appli- not include (i) processed dry animal cation of Inspection and food or (ii) livestock or poultry feeds Other Requirements manufactured from processed poultry byproducts (such as poultry byproduct § 381.3 Administration. meal, hydrolyzed poultry feathers, and (a) General authority to administer hydrolyzed poultry byproducts aggre- the Act has been delegated to the Ad- gate). ministrator (29 FR 16210, as amended; (61) Import Field Office (IFO). The of- 37 FR 6327, 6505). fice of the supervisor of import inspec- (b) The Administrator may in spe- tion activities for a particular import- cific classes of cases waive for limited ing field area. The areas are as follows: periods any provisions of the regula- IFO #1. Boston, MA—Covering the States tions in order to permit appropriate of Massachusetts, New York (excluding New and necessary action in the event of a York City), Connecticut, Rhode Island, Ver- public health emergency or to permit mont, New Hampshire, and Maine. IFO #2. New York, NY—Covering the areas experimentation so that new proce- of New York City and northern New Jersey. dures, equipment, and processing tech- IFO #3. Philadelphia, PA—Covering the niques may be tested to facilitate defi- State of Pennsylvania and the area of south- nite improvements: Provided, That such ern New Jersey. waivers of the provisions of the regula- IFO #4. Baltimore, MD—Covering the tions are not in conflict with the pur- States of Maryland, Delaware, West Vir- poses or provisions of the Act. ginia, Virginia and Kentucky. IFO #5. Charleston, SC—Covering the (c) Pursuant to section 6 of the Act, States of Tennessee, North Carolina, South the Administrator believes that, in es- Carolina, Georgia, and Florida (excluding tablishments processing poultry prod- south Florida). ucts at which inspection under the Act

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and regulations is required, the fre- employees and otherwise assuring com- quency with which and the manner in pliance with applicable regulatory re- which poultry products made from quirements, and poultry previously slaughtered and (iii) The procedures used in such es- eviscerated in official establishments tablishment to control the production are reinspected by Inspection Service process, environment, and resulting employees should be based on consider- product in order to assure and monitor ations relevant to effective regulation compliance with the requirements of of poultry products and protection of the Act and the rules and regulations the health and welfare of consumers. In promulgated thereunder. order to test procedures for use in (2) In assessing the characteristics of making such determinations and, in an establishment, the following factors particular, for determining whether are appropriate for consideration: and, if so, to what extent the intensity (i) The complexity of the processing of inspection coverage exceeds that operation(s) conducted at such estab- which should be deemed necessary pur- lishment, suant to section 6 of the Act, the Ad- (ii) The frequency with which each ministrator is initiating experimen- such operation is conducted at such es- tation of a new system of inspection tablishment, for reviewing the performance of estab- (iii) The volume of product resulting lishments and for designing the super- from each such operation at such es- vision and other conditions and meth- tablishment, ods of inspection coverage. For the pe- (iv) Whether and to what extent riod of such experimentation, the Ad- slaughter and evisceration operations ministrator shall identify establish- also are conducted at such establishments for review, and the frequency ment, and the manner of inspection by In- spection Service employees shall be de- (v) What, if any, food products not termined on the basis of the results of regulated under this Act or the Federal those reviews and be otherwise in ac- Meat Inspection Act also are processed cordance with this section. at such establishment, and (d) The determinations referred to in (vi) The size of such establishment. paragraph (c) of this section shall be (e)(1) For the period of experimen- made by the Inspection Service and tation described in paragraph (c) of shall reflect evaluations of the per- this section, the frequency of inspec- formance and the characteristics of tion by Inspection Service employees such establishments. of operations other than slaughter and (1) In assessing the performance of an evisceration may be reduced in an es- establishment, the following factors tablishment in which the procedures are appropriate for consideration: referred to therein are being tested if (i) The history of compliance with and only if the evaluation of the per- applicable regulatory requirements by formance of such establishment de- the person operating such establish- scribed in paragraph (d)(1) indicates ment or by anyone responsibly con- that there are: nected with the business operating (i) No instances, documented in such establishment, as ‘‘responsibly records compiled no earlier than 10 connected’’ is defined in section 18(a) of years before, of substantial and recent the Act, noncompliance with applicable regu- (ii) The competence of the person op- latory requirements (taking into ac- erating such establishment, as indi- count both the nature and frequency of cated by: any such noncompliance), and (A) Knowledge of appropriate manu- (ii) The competence and control pro- facturing practices and applicable reg- cedures needed to assure and monitor ulatory requirements, compliance with applicable regulatory (B) Demonstrated ability to apply requirements. such knowledge in a timely and con- (2)(i) The frequency of Federal in- sistent manner, and spection and other conditions and (C) Commitment to correcting defi- methods of inspection coverage in any ciencies noted by Inspection Service establishment in which the frequency

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of Federal inspection is reduced shall (b) Every establishment, except as be based on: provided in § 381.10 (a) and (b), (c), or (A) The evaluation of the character- (d), or § 381.11, within any State or or- istics of such establishment described ganized territory which is designated in paragraph (d)(2) of this section,1 in § 381.221 pursuant to section 5(c) of (B) The significance of potential pub- the Act, at which any poultry is lic health consequences of noncompli- slaughtered or any poultry products ance, and are processed, for use as human food (C) The availability of Inspection solely for distribution within such ju- Service employees. risdiction; and (ii) To the extent that frequency of (c) Except as provided in § 381.10 (a) inspection or other conditions and and (b), or (c), or § 381.11, every estab- methods of inspection coverage are lishment designated by the Adminis- identified as conflicting with provi- trator pursuant to section 5(c) of the sions of the regulations in this part, Act as one producing adulterated poul- the Administrator will waive such pro- try products which would clearly en- visions for the period of experimen- danger the public health. tation, in accordance with paragraph (b) of this section. § 381.7 Coverage of all poultry and poultry products processed in offi- [37 FR 9706, May 16, 1972, as amended at 52 cial establishments. FR 10033, Mar. 30, 1987] All poultry and poultry products § 381.4 Inspection in accordance with processed in an official establishment methods prescribed or approved. shall be inspected, handled, processed, Inspection of poultry products shall marked, and labeled as required by the be rendered pursuant to the regula- regulations. tions and under such conditions and in accordance with such methods as may Subpart C—Exemptions be prescribed or approved by the Ad- ministrator. § 381.10 Exemptions for specified operations. § 381.5 Publications. (a) The requirements of the Act and Publications under the Act and the the regulations for inspection of the regulations shall be made in the FED- processing of poultry and poultry prod- ERAL REGISTER and in such other media ucts shall not apply to: as the Administrator may designate. (1) Any retail dealer with respect to poultry products sold in commerce di- § 381.6 Establishments requiring in- rectly to consumers in an individual spection. retail store, if the only processing op- Inspection under the regulations is eration performed by such retail dealer required at: is the cutting up of poultry products on (a) Every establishment, except as the premises where such sales to con- provided in § 381.10 (a) and (b) or § 381.11, sumers are made: Provided, That such in which any poultry is slaughtered for operation is conducted under such sani- transportation or sale in commerce, or tary standards, practices, and proce- in which any poultry products are dures as result in the preparation of wholly or in part, processed for trans- poultry products that are not adulter- portation or sale in commerce, as arti- ated: And provided further, That the cles intended for use as human food; poultry products sold in commerce are derived from poultry inspected and 1 These evaluations will be based upon passed under the Act and such poultry guidelines developed by FSIS and the com- products are not adulterated or mis- plexity categorization in FSIS Directive branded at the time of sale (except that 1030.2 (Documentation of Processing and the official inspection legend shall not Combination Assignments, 4/22/85). The be used). (For the purposes of this sub- guidelines and Directive will be available for public inspection and copying in the Policy paragraph, a retail dealer is any person Office, Room 3168, South Agriculture Build- who sells poultry products directly to ing, 14th Street and Independence Avenue, consumers as defined in paragraph SW., Washington, DC. (d)(2)(vi) of this section and whose sales

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of poultry products to household con- for human food, and the shipping consumers constitute, in terms of dollar tainers of such poultry products bear value, at least 75 percent of his total the owner’s name and address and the sales of poultry products.) statement ‘‘Exempted—P.L. 90–492.’’ (2) The slaughter of poultry, and the (5) The slaughtering of sound and processing of poultry products, by any healthy poultry and processing of poul- person in any territory not organized try products therefrom in any State or with a legislative body, solely for dis- territory or the District of Columbia tribution within such territory: Pro- by any poultry producer on his own vided, That such poultry is sound and premises with respect to poultry raised healthy and is slaughtered under such on his premises, and the distribution sanitary standards, practices, and pro- by any person solely within such juris- cedures as result in the preparation of diction of the poultry products derived poultry products that are not adulter- from such operations: Provided, That (i) ated: And provided further, That the in lieu of complying with all the adul- poultry products are not adulterated or teration provisions of the Act, such misbranded when so distributed (except poultry is slaughtered and otherwise that the official inspection legend shall processed and handled under such sani- not be used). tary standards, practices, and proce- (3) The slaughtering by any person of dures as result in the preparation of poultry of his own raising, and the poultry products that are sound, clean, processing by him and transportation and fit for human food when so distrib- in commerce of the poultry products uted; (ii) such poultry products when exclusively for use by him and mem- so distributed, bear (in lieu of labeling bers of his household and his nonpay- that would otherwise be required) the ing guests and employees: Provided, producer’s name and address and the That in lieu of complying with all the statement ‘‘Exempted—P.L. 90–492’’ adulteration and misbranding provi- and such poultry products are not oth- sions of the Act, such poultry is erwise misbranded; (iii) such producer healthy and is slaughtered and proc- and distributor do not engage in the essed under such sanitary standards, current calendar year in the business practices, and procedures as result in of buying or selling any poultry or the preparation of poultry products poultry products other than as speci- that are sound, clean, and fit for fied in this paragraph (a) (5) or (6) of human food, and the shipping contain- this section; and (iv) neither such pro- ers of such poultry products bear the ducer or distributor slaughters or proc- producer’s name and address and the esses the products of more poultry statement ‘‘Exempted—P.L. 90–492.’’ than allowed by paragraph (b) of this (4) The custom slaughter by any per- section. son of poultry delivered by the owner (6) The slaughtering of sound and thereof for such slaughter, and the healthy poultry or the processing of processing by such slaughterer and poultry products of such poultry in any transportation in commerce of the State or territory or the District of Co- poultry products exclusively for use, in lumbia by any poultry producer or the household of such owner, by him other person for distribution by him and members of his household and his solely within such jurisdiction directly nonpaying guests and the employees: to household consumers, restaurants, Provided, That such custom slaughterer hotels, and boardinghouses, for use in does not engage in the business of buy- their own dining rooms, or in the prep- ing or selling any poultry products ca- aration of meals for sales direct to con- pable of use as human food: And pro- sumers: Provided, That (i) in lieu of vided further, That in lieu of complying complying with all the adulteration with all the adulteration and mis- provisions of the Act, such poultry is branding provisions of the Act, such slaughtered and otherwise processed poultry is healthy and is slaughtered and handled under such sanitary stand- and processed under such sanitary ards, practices, and procedures as re- standards, practices, and procedures as sult in the preparation of poultry prod- result in the preparation of poultry ucts that are sound, clean, and fit for products that are sound, clean and fit human food when distributed by such

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processor; (ii) such poultry products endar year for which this exemption is when so distributed bear (in lieu of la- being determined; beling that would otherwise be re- (2) Such poultry producer does not quired) the processor’s name and ad- engage in buying or selling poultry dress and the statement ‘‘Exempted— products other than those produced P.L. 90–492’’ and such poultry products from poultry raised on his own farm; are not otherwise misbranded; (iii) and such processor does not engage in the (3) None of such poultry moves in current calendar year in the business ‘‘commerce’’ (as defined in § 381.1). of buying or selling any poultry or (d)(1) The requirements of the Act poultry products other than as speci- and the regulations for inspection of fied in this paragraph (a) (6) or (5) of the processing of poultry and poultry this section; and (iv) such processor products do not apply to operations of does not exceed the volume limitation types traditionally and usually con- prescribed in paragraph (b) of this sec- ducted at retail stores and restaurants, tion. when conducted at any retail store or (7) The operations and products of restaurant or similar-retail-type estab- small enterprises (including poultry lishment for sale in normal retail producers) not exempted under para- quantities or service of such articles to graphs (a) (1) through (6) of this section consumers at such establishments. that are engaged in any State or terri- (2) For the purposes of paragraph tory or the District of Columbia in (d)(1) of this section: slaughtering and/or cutting up poultry (i) Operations of types traditionally for distribution as carcasses or parts and usually conducted at retail stores thereof solely for distribution within and restaurants include any processing such jurisdiction; Provided, That (i) of poultry products except canning of such poultry is sound and healthy when poultry products and except slaughter- slaughtered and is slaughtered and/or ing of poultry unless such slaughtering cut up and handled under such sanitary is conducted at a retail store with re- standards, practices and procedures as spect to live poultry purchased by the result in the preparation of poultry consumer at the retail store and proc- products that are not adulterated when essed by the retail store operator in ac- so distributed; and (ii) when so distrib- cordance with the consumer’s instruc- uted, such poultry products are not tions. (ii) A normal retail quantity is any misbranded (except that the official in- quantity of a poultry product pur- spection legend shall not be used). chased by a household consumer from a (b) No person qualifies for any ex- retail supplier that in the aggregate emption specified in paragraph (a)(5), does not exceed 75 pounds. A normal re- (6), or (7) of this section if, in the cur- tail quantity sold by a retail supplier rent calendar year, such person: to other than a household consumer is (1) Slaughters or processes the prod- any quantity that in the aggregate ucts of more than 20,000 poultry, or does not exceed 150 pounds. (2) Slaughters or processes poultry (iii) A retail store is any place of products at a facility used for slaugh- business where: tering or processing poultry products (a) The sales of poultry products are by any other person, except when the made to consumers only; Administrator grants such exemption (b) At least 75 percent, in terms of after determining, upon review of a dollar value, of total sales of product person’s application, that such an ex- represents sales to household consum- emption will not impair effectuating ers and the total dollar value of sales the purposes of the Act. of product to consumers other than (c) The provisions of the Act and the household consumers does not exceed regulations do not apply to any poultry the dollar limitation per calendar year producer with respect to poultry, of his set by the Administrator. This dollar own raising on his own farm, which he limitation is a figure which will auto- slaughters if: matically be adjusted during the first (1) Such producer slaughters not quarter of each calendar year, upward more than 1,000 poultry during the cal- or downward, whenever the Consumer

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Price Index, published by the Bureau of if the restaurant central kitchen pre- Labor Statistics, Department of Labor, pares poultry products that are ready indicates a change in the price of this to eat when they leave such facility same volume of product which exceeds (i.e., no further cooking or other prepa- $500. Notice of the adjusted dollar limi- ration is needed, except that they may tation will be published in the FEDERAL be reheated prior to serving if chilled REGISTER.1 during transportation), transported di- (c) Only federally or State inspected rectly to a receiving restaurant by its and passed, or exempted (or, as pro- own employees, without intervening vided in § 381.223, State or local agency transfer or storage, maintained in a inspected and passed or exempted) safe, unadulterated condition during poultry products are handled or used in transportation, and served in meals or the preparation of any poultry prod- as entrees only to customers at res- ucts; taurants, or through vending ma- (d) No sale of poultry products is chines, owned or operated by the same made in excess of a normal retail quan- person that owns or operates such fa- tity as defined in paragraph (d)(2)(ii) of cility, and which otherwise meets the this section; and requirement of this paragraph: (e) The processing of poultry prod- Pro- ucts for sale is limited to traditional vided, That the requirements of §§ and usual operations as defined in 381.175 through 381.178 of this subparagraph (d)(2)(i) of this section. chapter apply to such facility. Provided (iv) Restaurants. (a) A restaurant is further, That the exempted facility any establishment where: may be subject to inspection require- (1) Poultry products are processed ments under the Act for as long as the only for sale or service in meals or as Administrator deems necessary if the entrees directly to individual consum- Administrator determines that the ers at such establishments; sanitary conditions or practices of the (2) Only federally inspected and facility or the processing procedures or passed, or exempted (or, as provided in methods at the facility are such that § 381.223, State or local agency in- any of its poultry products are ren- spected and passed or exempted) poul- dered adulterated. When the Adminis- try products are handled or used in the trator has made such determination preparation of any poultry products; and subjected a restaurant central (3) No sale of poultry products is kitchen facility to such inspection re- made in excess of a normal retail quan- quirements, the operator of such facil- tity as defined in paragraph (d)(2)(ii) of ity shall be afforded an opportunity to this section; and dispute the Administrator’s determina- (4) The processing of poultry prod- tion in a hearing pursuant to rules of ucts is limited to traditional and usual practice which will be adopted for this operations as defined in paragraph proceeding. (d)(2)(i) of this section. (v) A similar retail-type establish- (b) The definition of a restaurant in- ment is any establishment which is a cludes a caterer which delivers or combination retail store and res- serves product in meals, or as entrees, taurant; any delicatessen which meets only to individual consumers and oth- the requirements for a retail store or erwise meets the requirements of this restaurant as prescribed in paragraph paragraph. (d)(2) (iii) or (iv) of this section; or (c) For purposes of this paragraph, other establishment as determined by operations conducted as a restaurant the Administrator in specific cases. central kitchen facility shall be consid- (vi) A consumer is any household ered as being conducted at a restaurant consumer, hotel, or restaurant, or similar institution as determined by 1 The dollar limitation currently in effect the Administrator in specific cases. may be obtained by contacting Director, (3) Whenever any complaint is re- Slaughter Inspection Standards and Proce- dures Division, Technical Services, Food ceived by the Administrator from any Safety and Inspection Service, U.S. Depart- person alleging that any retail estab- ment of Agriculture, Washington, DC 20250 lishment or restaurant claiming ex- (202) 447–3219. emption under this paragraph (d) in

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any designated State or organized ter- (i.e., no further cooking or other prepa- ritory listed in § 381.221 that is also ration is needed, except that they may identified in § 381.224 as a jurisdiction be reheated prior to serving if chilled that does not have or is not exercising during transportation), transported di- adequate authority with respect to rec- rectly to the receiving institution by ordkeeping requirements, has been op- employees of the preparing firm, re- erated in violation of the conditions ceiving institution, or a food service prescribed in this paragraph (d) for management company contracted to such exemption, and the Adminis- conduct food service at the public or trator, upon investigation of the com- private nonprofit institution, without plaint, has reason to believe that any intervening transfer or storage. such violation has occurred, he shall so (2) The definitions at Chapter 1, 1–102, notify the operator of the retail estab- except 1–102(z) and the provisions of lishment or restaurant and afford him Chapters 2 through 8, except sections 2– reasonable opportunity to present his 102 (a) and (b), 2–302(d), 2–403(a), 2– views informally with respect to the 403(c), 2–404, 2–405, 2–407, 2–502 through matter. Thereafter, if the Adminis- 2–506, 2–508, 2–509, 4–105, 4–201(c), 4–208, trator determines that such a violation 5–101(a), 5–103, 5–104, 5–202(c), 5–203, and has occurred, and that a requirement 6–105, Part IV, of the Food and Drug that the operator keep records con- Administration’s Food Service Sanita- cerning the operations of the retail es- tion Manual (1976 Recommendations), tablishment or restaurant would effec- DHEW Publication No. (FDA) 78–2081, tuate the purposes of the Act, the Ad- which is incorporated by reference, ministrator shall order the operator to shall apply to the facilities and oper- maintain complete, accurate, and legations of businesses claiming this ex- ible records of his total monthly pur- emption. (These materials are incor- chases and of his total monthly sales of porated as they exist on the date of ap- poultry and poultry products. Such proval. This incorporation by reference records shall separately show total was approved by the Director of the sales to household consumers and total Federal Register in accordance with 5 sales to other consumers, and shall be U.S.C. 552(a) and 1 CFR part 51. Copies maintained for the period prescribed in may be purchased from the Super- § 381.177. If the operator maintains cop- intendent of Documents, U.S. Govern- ies of bills of lading, receiving and ment Printing Office, Washington, DC shipping invoices, warehouse receipts, 20402. It is also available for inspection or similar documents which give the at the Office of the Federal Register In- information required herein, additional formation Center, Suite 700, 800 North records are not required by this sub- Capitol Street, NW., Washington, DC, paragraph. or the FSIS Hearing Clerk, room 3171, (4) The adulteration and misbranding South Building, Food Safety and In- provisions of the Act and the regula- spection Service, U.S. Department of tions other than the requirement of the Agriculture, Washington, DC 20250.) official inspection legend, apply to ar- (3) Facilities and operations of busi- ticles which are exempted from inspec- nesses claiming this exemption shall tion under this paragraph (d). also conform to the following require- (e)(1) The requirements of the Act ments: and the regulations in this subchapter (i) Manual cleaning and sanitizing. (A) for inspection of the preparation of For manual washing, rinsing and sani- products do not apply to poultry pizzas tizing of utensils and equipment, a sink containing poultry product ingredients with not fewer than three compart- which were prepared, inspected, and ments shall be provided and used. Sink passed in a cured or cooked form as compartments shall be large enough to ready-to-eat (i.e., no further cooking or permit the accommodation of the other preparation is needed) in compli- equipment and utensils, and each com- ance with the requirements of the Act partment of the sink shall be supplied and these regulations; and the poultry with hot and cold potable running pizzas are to be served in public or pri- water. Fixed equipment and utensils vate nonprofit institutions, provided and equipment too large to be cleaned that the poultry pizzas are ready to eat in sink compartments shall be washed

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manually or cleaned through pressure temperature of at least 75 °F for 1 spray methods. minute; or (B) Drain boards or easily movable (5) Treatment with steam free from dish tables of adequate size shall be materials or additives other than those provided for proper handling of soiled specified in 21 CFR 173.310 in the case utensils prior to washing and for of equipment too large to sanitize by cleaned utensils following sanitizing immersion, but in which steam can be and shall be located so as not to inter- confined; or fere with the proper use of the dish- (6) Rinsing, spraying, or swabbing washing facilities. with a chemical sanitizing solution of (C) Equipment and utensils shall be at least twice the strength required for preflushed or prescraped and, when that particular sanitizing solution necessary, presoaked to remove gross under paragraph (e)(3)(i)(E)(4) of this food particles and soil. section in the case of equipment too (D) Except for fixed equipment and large to sanitize by immersion. utensils too large to be cleaned in sink (F) When hot water is used for sani- compartments, manual washing, rins- tizing, the following facilities shall be ing and sanitizing shall be conducted in provided and used: the following sequence: (1) An integral heating device or fix- (1) Sinks shall be cleaned prior to ture installed in, on, or under the sani- use. tizing compartment of the sink capable (2) Equipment and utensils shall be of maintaining the water at a tempera- thoroughly washed in the first com- ture of at least 170 °F; and partment with a hot detergent solution that is kept clean. (2) A numerically scaled indicating thermometer, accurate to ±3°F, conven- (3) Equipment and utensils shall be rinsed free of detergent and abrasives ient to the sink for frequent checks of with clean water in the second com- water temperature; and partment. (3) Dish baskets of such size and de- (4) Equipment and utensils shall be sign to permit complete immersion of sanitized in the third compartment ac- the tableware, kitchenware, and equip- cording to one of the methods pre- ment in the hot water. scribed in paragraph (e)(3)(i)(E) (1) (G) When chemicals are used for sani- through (4) of this section. tization, they shall not have con- (E) The food-contact surfaces of all centrations higher than the maximum equipment and utensils shall be sani- permitted under 21 CFR 178.1010 and a tized by: test kit or other device that accurately (1) Immersion for at least 1⁄2 minute measures the parts per million con- in clean, hot water at a temperature of centration of the solution shall be pro- at least 170 °F; or vided and used. (2) Immersion for at least 1 minute in (ii) Mechanical cleaning and sanitizing. a clean solution containing at least 50 (A) Cleaning and sanitizing may be parts per million of available chlorine done by spray-type or immersion dish- as a hypochlorite and at a temperature washing machines or by any other type of at least 75 °F; or of machine or device if it is dem- (3) Immersion for at least 1 minute in onstrated that it thoroughly cleans a clean solution containing at least 12.5 and sanitizes equipment and utensils. parts per million of available iodine These machines and devices shall be and having a pH not higher than 5.0 properly installed and maintained in and at a temperature of at least 75 °F; good repair. Machines and devices shall or be operated in accordance with manu- (4) Immersion in a clean solution facturers’ instructions, and utensils containing any other chemical sanitiz- and equipment placed in the machine ing agent allowed under 21 CFR 178.1010 shall be exposed to all dishwashing cy- that will provide the equivalent bac- cles. Automatic detergent dispensers, tericidal effect of a solution containing wetting agent dispensers, and liquid at least 50 parts per million of avail- sanitizer injectors, if any, shall be able chlorine as a hypochlorite at a properly installed and maintained.

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(B) The pressure of final rinse water (1) The temperature of the wash supplied to spray-type dishwashing ma- water shall not be less than 120 °F. chines shall not be less than 15 nor (2) The wash water shall be kept more than 25 pounds per square inch clean. measured in the water line imme- (3) Chemicals added for sanitization diately adjacent to the final rinse con- purposes shall be automatically dis- trol valve. A 1⁄4-inch IPS valve shall be pensed. provided immediately upstream from (4) Utensils and equipment shall be the final rinse control valve to permit exposed to the final chemical sanitiz- checking the flow pressure of the final ing rinse in accordance with manufac- rinse water. turers’ specifications for time and con- (C) Machine or water line mounted centration. numerically scaled indicating ther- (5) The chemical sanitizing rinse mometers, accurate to ±3°F, shall be water temperature shall be not less provided to indicate the temperature of than 75 °F nor less than the tempera- the water in each tank of the machine ture specified by the machine’s manu- and the temperature of the final rinse facturer. water as it enters the manifold. (6) Chemical sanitizers used shall (D) Rinse water tanks shall be pro- meet the requirements of 21 CFR tected by baffles, curtains, or other ef- 178.1010. fective means to minimize the entry of (7) A test kit or other device that ac- wash water into the rinse water. Con- curately measures the parts per mil- veyors in dishwashing machines shall lion concentration of the solution shall be accurately timed to assure proper be available and used. exposure times in wash and rinse cy- (H) Machines using hot water for cles in accordance with manufacturers’ sanitizing may be used provided that specifications attached to the ma- wash water and pumped rinse water chines. shall be kept clean and water shall be (E) Drain boards shall be provided maintained at not less than the follow- and be of adequate size for the proper ing temperatures: handling of soiled utensils prior to (1) Single-tank, stationary-rack, washing and of cleaned utensils follow- dual-temperature machine: ing sanitization and shall be so located ° and constructed as not to interfere Wash temperature ...... 150 F Final rinse temperature ...... 180 °F with the proper use of the dishwashing facilities. This does not preclude the (2) Single-tank, stationary-rack, sin- use of easily movable dish tables for gle-temperature machine: the storage of soiled utensils or the use Wash temperature ...... 165 °F of easily movable dishtables for the Final rinse temperature ...... 165 °F storage of clean utensils following sanitization. (3) Single-tank, conveyor machine: (F) Equipment and utensils shall be Wash temperature ...... 160 °F flushed or scraped and, when necessary, Final rinse temperature ...... 180 °F soaked to remove gross food particles (4) Multitank, conveyor machine: and soil prior to being washed in a dishwashing machine unless a Wash temperature ...... 150 °F prewashcycle is a part of the dishwash- Pumped rinse temperature ...... 160 °F ing machine operation. Equipment and Final rinse temperature ...... 180 °F utensils shall be placed in racks, trays, (5) Single-tank, pot, pan, and utensil or baskets, or on conveyors, in a way washer (either stationary or moving- that food-contact surfaces are exposed rack): to the unobstructed application of detergent wash and clean rinse waters Wash temperature ...... 140 °F ° and that permits free draining. Final rinse temperature ...... 180 F (G) Machines (single-tank, station- (I) All dishwashing machines shall be ary-rack, door-type machines and thoroughly cleaned at least once a day spray-type glass washers) using chemi- or more often when necessary to main- cals for sanitization may be used: Pro- tain them in a satisfactory operating vided, That, condition.

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(iii) Steam. Steam used in contact when the Administrator determines with food or food-contact surfaces shall that an imminent threat to food safety be free from any materials or additives or public health exists, and that such other than those specified in 21 CFR action is, therefore, necessary to pro- 173.310. tect the public health, interest or safe- (4) For purposes of this paragraph, ty. Such withdrawal or modification the term ‘‘private nonprofit institu- shall be effective upon oral or written tion’’ means ‘‘a corporation, and any notification, whichever is earlier, to community chest, fund, or foundation, the owner or operator of the particular organized and operated exclusively for establishment as promptly as cir- religious, charitable, scientific, testing cumstances permit. In the event of oral for public safety, literary, or edu- notification, written confirmation cational purposes, or to foster national shall be given to the owner or operator or international amateur sports com- of the establishment as promptly as petition (but only if no part of its ac- circumstances permit. This withdrawal tivities involve the provision of ath- or modification shall continue in effect letic facilities or equipment), or for the pending the completion of the proceed- prevention of cruelty to children or ing and any judicial review thereof, un- animals, no part of the net earnings of less otherwise ordered by the Adminis- which inures to the benefit of any pri- trator. vate shareholder or individual, no sub- (6) The adulteration and misbranding stantial part of the activities of which provisions of the Act and the regula- is carrying on propaganda, or other- tions apply to articles which are ex- wise attempting, to influence legisla- empted from inspection under tion, and which does not participate in, § 381.10(e). or intervene in (including the publish- [37 FR 9706, May 16, 1972, as amended at 38 ing or distribution of statements), any FR 16991, June 28, 1973; 45 FR 27922, Apr. 25, political campaign on behalf of (or in 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, opposition to) any candidate for public Jan. 24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR office.’’ 24679, June 30, 1988; 57 FR 34184, Aug. 3, 1992] (5) The Administrator may withdraw or modify the exemption set forth in § 381.11 Exemptions based on religious § 381.10(e)(1) for a particular establish- dietary laws. ment when he or she determines that (a) Any person who slaughters, proc- such action is necessary to ensure food esses, or otherwise handles poultry or safety and public health. Before such poultry products which have been or action is taken, the owner or operator are to be processed as required by rec- of the particular establishment shall be ognized religious dietary laws may notified, in writing, of the reasons for apply for exemption from specific pro- the proposed action and shall be given visions of the Act or regulations which an opportunity to respond, in writing, are in conflict with such religious die- to the Administrator within 20 days tary laws. Any person desiring such an after notification of the proposed ac- exemption shall apply in writing to the tion. The written notification shall be Meat and Poultry Inspection Program, served on the owner or operator of the Food Safety and Inspection Service, establishment in the manner pre- Department of Agriculture, Washing- scribed in section 1.147(b) of the De- ton, DC 20250, setting forth the specific partment’s Uniform Rules of Practice provisions of the Act and the regula- (7 CFR 1.147(b)). In those instances tions from which exemption is sought where there is conflict of any material and setting forth the provisions of the fact, the owner or operator of the es- religious dietary laws in support of the tablishment, upon request, shall be af- requested exemption. In addition, the forded an opportunity for a hearing applicant for such an exemption shall with respect to the disputed fact, in ac- submit a statement from the clerical cordance with rules of practice which official having jurisdiction over the en- shall be adopted for the proceeding. forcement of the religious dietary laws However, such withdrawal or modifica- with respect to the poultry or poultry tion shall become effective pending products involved, which identifies the final determination in the proceeding requirements of such laws pertaining

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to the slaughter of the poultry and the such action will aid in effectuating the processing or other handling of the purposes of the Act. Failure to comply poultry products involved, and certifies with the conditions of the exemption, that such requirements are in conflict including, but not limited to, failure to with specific provisions of the Act and process poultry and poultry products regulations from which the exemption under clean and sanitary conditions is sought. may result in termination of an exemp- (b) The Administrator, upon a deter- tion, in addition to any other penalties mination that an exemption should be provided by law. granted, will grant such exemption to (b) Except as provided in § 381.10(c), the extent necessary to avoid conflict the Administrator may extend the re- with the religious requirements while quirements of the Act to any establish- still effectuating the purposes of the ment in any State or organized terri- Act. He may impose such conditions as tory at which poultry products are to sanitary standards, practices, and processed for distribution solely within procedures in granting such exemption such jurisdiction if he determines in as he deems necessary to effectuate the accordance with the provisions of sub- purposes of the Act. Any person who paragraph 5(c)(1) of the Act that the es- processes poultry or poultry products tablishment is producing adulterated under exemption from certain require- poultry products which would clearly ments as provided in this section shall endanger the public health. be subject to all of the other applicable provisions of the Act and the regula- § 381.14 Inspection concerning pur- tions. Processing plants shall meet the portedly exempted operations. sanitary requirements set forth in this Inspectors of the Inspection Service part and unless exempted from inspec- are authorized to make inspections in tion under the provisions of this sub- accordance with law to ascertain part, shall be required to qualify for in- whether any of the provisions of the spection and operate as official estab- Act or the regulations applying to pro- lishments. Slaughtered poultry which ducers, retailers, or other persons pur- is prepared under an exemption author- porting to be exempted from any re- izing the sale of noneviscerated poultry quirements under this subpart have in commerce shall be individually iden- been violated. tified with a label approved by the Ad- ministrator which identifies the cleri- § 381.15 Exemption from definition of cal official under whose supervision the ‘‘poultry product’’ of certain human poultry was slaughtered. food products containing poultry. The following articles contain poul- § 381.12 Effect of religious dietary laws try ingredients only in a relatively exemptions on other persons. small proportion or historically have Whenever a slaughterer or processor not been considered by consumers as is granted an exemption under § 381.11 products of the poultry food industry. with respect to the slaughtering or Therefore said articles are exempted processing of any poultry or poultry from the definition of ‘‘poultry prod- products under this part, under speci- uct’’ and the requirements of the Act fied conditions, the sale, offer for sale, and the regulations applicable to poul- transportation and other handling in try products, if they comply with the commerce by any person of such poul- conditions specified in this section. try and poultry products in accordance (a) Any human food product (in a with such conditions is hereby author- consumer package) not provided for in ized, except as restricted by the Act. paragraph (c) of this section, if: (1) It contains less than 2 percent § 381.13 Suspension or termination of cooked poultry meat (deboned white or exemptions. dark poultry meat, or both) and/or (a) The Administrator may, by order, ‘‘Mechanically Separated (Kind of in accordance with the applicable rules Poultry)’’ as defined in § 381.173; of practice suspend or terminate any (2) It contains less than 10 percent of exemption under § 381.10(a) with respect cooked poultry skins, giblets, or fat, to any person whenever he finds that separately, and less than 10 percent of

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cooked poultry skins, giblets, fat, and ply with the provisions of paragraphs meat (as meat is limited in paragraph (a)(3), (4), and (5) of this section in all (a)(1) of this section) or ‘‘Mechanically respects. Separated (Kind of Poultry)’’ as defined (e) Products of the types specified in in § 381.173, in any combination; this section except those specified in (3) The poultry ingredients used in paragraphs (c) and (d) of this section the product were prepared under in- will be deemed to be represented as spection as defined in § 381.1, or were poultry products if the kind name of inspected under a foreign inspection the poultry (chicken, turkey, etc.) is system approved under § 381.196(b) and used in the product name of the prod- imported in compliance with the Act uct without appropriate qualification. and the regulations; For example, a consumer-packaged (4) The immediate container of the noodle soup product containing less product bears a label which shows the than 2 percent chicken meat on a name of the product in accordance with ready-to-serve basis may not be labeled this section; and ‘‘Chicken Noodle Soup’’ but, when ap- (5) The product is not represented as propriate, could be labeled as ‘‘Chicken a poultry product. The aforesaid per- Flavored Noodle Soup.’’ Products ex- centages of ingredients shall be com- empted under this section are subject puted on the basis of the moist, to the requirements of the Federal deboned, cooked poultry in the ready- Food, Drug, and Cosmetic Act. to-serve product when prepared according to the serving directions on the [37 FR 9706, May 16, 1972, as amended at 60 consumer package. FR 55982, Nov. 3, 1995] (b) Any human food product (in an institutional pack), not provided for in Subpart D—Application for In- paragraph (c) of this section, if: spection; Grant or Refusal of (1) It is prepared for sale only to in- Inspection stitutional users, such as hotels, restaurants, and boardinghouses, for use § 381.16 How application shall be as a soup base or flavoring; made. (2) It contains less than 15 percent The operator of each establishment cooked poultry meat (deboned white or of the kind required by § 381.6 to have dark poultry meat or both) and/or ‘‘Me- inspection shall make application to chanically Separated (Kind of Poul- the Administrator for inspection serv- try)’’ as defined in § 381.173, computed ice. In cases of change of name, owner- on the basis of the moist deboned, ship, or location, a new application cooked poultry meat and/or ‘‘Mechani- shall be made. cally Separated (Kind of Poultry)’’ in such product; and § 381.17 Filing of application. (3) It complies with the provisions of paragraphs (a)(3), (4), and (5) of this Every application for inspection at section in all respects. any establishment shall be made by the (c) Bouillon cubes, poultry broths, operator on a form furnished by the gravies, sauces, seasonings, and Meat and Poultry Inspection Program, flavorings if: Food Safety and Inspection Service, (1) They contain poultry meat and/or U.S. Department of Agriculture, Wash- ‘‘Mechanically Separated (Kind of ington, DC 20250, and shall include all Poultry)’’ as defined in § 381.173 or poul- information called for by that form, in- try fat only in condimental quantities; cluding the name of any subsidiary cor- (2) They comply with the provisions poration that will prepare any poultry of paragraphs (a)(3), (4), and (5) of this product or conduct any other operation section in all respects; and at the establishment for which inspec- (3) In the case of poultry broth, it tion is requested. The applicant for in- will not be used in the processing of spection will be held responsible for any poultry product in any official es- compliance by all its subsidiaries with tablishment. the requirements of the regulations at (d) Fat capsules and sandwiches con- such establishments if inspection is taining poultry products if they com- granted. Processing of poultry products

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and other operations at the establish- cate the scale used and shall also indi- ment for which inspection is granted cate the floor shown (e.g. basement, may be conducted only by the appli- first or second). cant, except that such a subsidiary of (b) Features required to be shown on the grantee, may conduct such oper- floor plan. The following features shall ations at such establishment. be shown on the floor plan: (1) The principal pieces of equipment § 381.18 Authority of applicant. drawn to scale in the proper locations; Any person applying for inspection (2) The name of the operator and ad- service may be required at the discre- dress of the establishment by street tion of the Administrator to dem- and street number, or by other means onstrate that the operator of the estab- properly identifying the location of the lishment authorized him to do so. establishment. (This information shall be shown on each drawing the same as § 381.19 Application for inspection; re- shown on the application for service quired facilities. (Form MP–401)); An application for inspection service (3) One point of the compass; under this part shall be made according (4) The doors and openings for pas- to the following procedure: sageways, designating those which are (a) Prints of drawings and specifica- self-closing or permanently closed; tions to be furnished. (1) Applicants for (5) All floor drain openings and gut- inspection service may obtain informa- ter drains, and for all buildings con- tion or assistance from the Inspection structed after September 1, 1959, the Service with respect to the require- approximate location of all underfloor ments before submitting prints of and underground piping; drawings and specifications. (6) Lavatories in toilet and process- (2) Two prints of drawings showing ing rooms (lavatories which are other the features specified in this section than hand operated shall be so des- shall be submitted to the Adminis- ignated on the blueprints); trator. Photostats of drawings are not (7) All steam and hot and cold water acceptable. The drawings and prints outlets for cleanup purposes; shall be legible, made with sharp, clear (8) Ice making and storage facilities; lines, and properly drawn to scale, and (9) The point at which live poultry is shall consist of complete floor plans hung on the conveyor line, the point and a plot plan. Submissions consisting where dressed poultry is removed, and of more than one sheet shall be bound the point of transfer to the eviscerat- together at the left margin in sets. ing line; (3) The plot plan shall show such features as the limits of the establishment (10) The routes of the edible and ined- premises, location in outline of build- ible products; ings on the premises, one point of the (11) The location of fresh air inlets, compass, and the location of roadways, exhaust fans and hoods. railroads, and water and sewer lines or (c) Specifications. Four sets of speci- sewage facilities serving the establish- fications covering the following shall ment. accompany the drawings: (4) The floor plan shall show all space (1) Height of ceilings; to be included in the official establish- (2) Type of ceilings—open or closed; ment. If rooms or compartments shown (3) Finish of ceilings; for example— on the drawings are not to be included cement plaster, metal, marine ply- as part of the official establishment, wood, cement, asbestos board, etc.; this shall be clearly indicated thereon. (4) Finish of walls; for example—ce- (5) The sheets of paper on which ment plaster, glazed tile, glazed brick, prints of drawings are made shall not glass blocks, etc.; exceed a size of 34′′ x 44′′. The drawings, (5) Screens—indicate whether all out- other than of the plot plan, shall be side openings are screened or provided made to a scale of one-eighth inch per with other suitable devices against en- foot. The plot plan may be drawn to a trance of flies or other insects; scale of not less than one thirty-second (6) Finish of floors—concrete, brick, inch per foot. The drawings shall indi- mastic material, etc.;

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(7) Drainage—indicate amount of (1) A completely revised sheet or slope of floors to the drains in process- sheets, showing proposed alterations or ing rooms, coolers, toilets, and refuse additions, or rooms, and give description of trapping (2) Pasters of minor changes which and venting of drainage lines, and of may be affixed to the affected areas on floor drain openings. Indicate size of the previously approved drawings in a drainage lines and whether house manner not obscuring essential data. drainage lines and toilet soil lines are Paster drawings shall be prepared to separate to a point outside of build- the same scale and presented on a ings; background similar to that of the (8) Heating—indicate type; originally approved drawing. (9) Water supply—indicate whether (f) Use of information on file for plants public or private water supply, or both, operating under voluntary inspection and specify in terms of gallons per service. Applicants whose plants have minute of water available for the proc- been surveyed and are operating under essing needs of the plant. Also indicate voluntary inspection service pursuant whether or not a nonpotable water sup- to regulations (Part 362 of this chapter) ply is used for any purpose in the plant in effect on the date service is made and, if so, specify such uses; available under the Act will be exempt (10) Hot water facilities—specify fa- from the requirements of this section cilities such as boilers, storage tanks, to the extent that the Administrator mixing valves, etc., and indicate the may determine that information and size; materials requried by the provisions of (11) Specify number of men and num- this section are already available in of- ber of women who will use each toilet ficial files of the Inspection Service. room; (g) Irradiation facilities. Applicants for (12) Sewage disposal—indicate wheth- inspection whose processing is limited er city sewer, cesspool, sedimentation to irradiation of packaged poultry tank, etc.; product while in the custody of the es- (13) Approximate rate of production— tablishment need not submit informa- for slaughtering and/or eviscerating es- tion required by this section, provided tablishments, indicate hourly rate of the applicant has submitted to the Ad- slaughter and/or evisceration for each ministrator a proposed quality control class of poultry, and for other types of system as specified in § 381.149 of this establishments, indicate pounds of part. All applicants for inspection each type of poultry products processed whose operations include irradiation per hour. and other processing would submit, to (d) Rooms and compartments which the Administrator, a proposed quality must be shown on the drawings. The control system as specified in § 381.149 drawings of the establishment shall of this part, in addition to information show employees’ toilet and dressing required in this section. rooms, office space for the inspectors, [37 FR 9706, May 16, 1972, as amended at 41 storerooms for supplies, refuse rooms, FR 4889, Feb. 3, 1976; 57 FR 43597, Sept. 21, and all rooms, compartments, or pas- 1992] sageways where poultry or poultry products, or any ingredients to be used § 381.20 Survey and grant of inspec- in the preparation of poultry products tion. will be handled or kept. The drawings Prior to granting of inspection serv- shall also show all other rooms or com- ice, a survey of the establishment shall partments located in the buildings that be made by a representative of the In- are to comprise the official establish- spection Service to determine if the es- ment. tablishment is constructed and facili- (e) Changes in drawings or blueprints. ties are installed in accordance with When changes are proposed in areas for the approved drawings, specifications, which drawings have been previously and the regulations. Inspection will be approved, one of the following types of granted by the Administrator when revised drawings shall be submitted for these requirements are met, subject to review and consideration: § 381.21.

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§ 381.21 Refusal of inspection. ministrator (as defined in § 381.1) is re- (a) The Administrator may refuse to quired by paragraph (2) of said sub- grant inspection at any establishment section to notify the Administrator of if he determines that it does not meet the Environmental Protection Agency any requirements as to premises, fa- for proceedings in accordance with that cilities, and equipment, and the oper- paragraph. No grant of inspection can ation thereof, prescribed in the regula- be made until the requirements of said tions under section 7 of the Act to pre- paragraph (2) have been met. vent the distribution under the Act of (2) However, certification under sub- adulterated poultry products, or that section 21(b) of the Federal Water Pol- the applicant has not received approval lution Control Act is not initially re- of labeling and containers to be used at quired in connection with an applica- the establishment as required by the tion for inspection granted after April regulations. When inspection is refused 3, 1970, for facilities existing or under for any such reason, the applicant shall construction on April 3, 1970, although be informed of the action and the rea- certification for such facilities is re- sons therefor and afforded an oppor- quired to be obtained within the 3–year tunity to present his views informally. period immediately following April 3, (b) If the refusal is based on a failure 1970. Failure to obtain such certifi- to comply with any requirements pre- cation or to meet the other require- scribed under section 7 of the Act, the ments of subsection 21(b) prior to April applicant shall, upon his request, be af- 3, 1973, will result in the termination of forded opportunity for a hearing in ac- inspection at such facilities on that cordance with applicable rules of prac- date. tice, with respect to the merits or va- (3) Further, any application for in- lidity of the action taken, but such re- spection pending on April 3, 1970, and fusal shall continue in effect unless granted within 1 year thereafter shall otherwise ordered by the Secretary. not require certification for 1 year fol- (c) Inspection may also be refused in lowing the grant of inspection but such accordance with section 18(a) of the grant of inspection shall terminate at Act and the applicable rules of prac- the end of 1 year after its issuance un- tice. less prior thereto such certification has (d)(1) Any applicant for inspection at been obtained and the other require- an establishment where the operations ments of subsection 21(b) are met. thereof may result in any discharge (4) In the case of any activity which into the navigable waters of the United will affect water quality but for which States is required by subsection 21(b) of there are no applicable water quality the Federal Water Pollution Control standards, no certification is required Act, as amended, to provide the Admin- prior to the grant of inspection but istrator with a certification as pre- such grant will be conditioned upon a scribed in said subsection that there is requirement of compliance with the reasonable assurance that such activ- purpose of the Federal Water Pollution ity will be conducted in a manner Control Act as provided in paragraph which will not violate the applicable 21(b)(9) of said Act. water quality standards. No grant of inspection can be issued after April 3, § 381.22 Conditions for receiving in- 1970 (the date of enactment of the spection. Water Quality Improvement Act), un- (a) Before being granted Federal in- less such certification has been ob- spection, an establishment shall have tained, or is waived because of failure developed written sanitation Standard or refusal of the State, interstate agen- Operating Procedures, in accordance cy, or the Administrator of the Envi- with Part 416 of this chapter. ronmental Protection Agency to act on (b) Before being granted Federal in- a request for certification within 1 year spection, an establishment shall have after receipt of such request. Further, conducted a hazard analysis and devel- upon receipt of an application for in- oped and validated a HACCP plan, in spection and a certification as required accordance with §§ 417.2 and 417.4 of this by subsection 21(b) of the Federal chapter. A conditional grant of inspec- Water Pollution Control Act, the Ad- tion shall be issued for a period not to

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exceed 90 days, during which period the lishment at the time service is inaugu- establishment must validate its rated contains any poultry product HACCP plan. which has not been inspected and (c) Before producing new product for marked in compliance with the regula- distribution in commerce, an establish- tions, its identity shall be maintained, ment shall have conducted a hazard and it shall not be represented or dealt analysis and developed a HACCP plan with as a product which has been inapplicable to that product in accord- spected. Such products may not be ance with § 417.2 of this chapter. During shipped in commerce unless such prod- a period not to exceed 90 days after the ucts are eligible for such shipment date the new product is produced for under an exemption from inspection distribution in commerce, the estab- under subpart C and comply with all lishment shall validate its HACCP requirements of said subpart. plan, in accordance with § 417.4 of this chapter. § 381.28 Report of violations. [61 FR 38866, July 25, 1996] Each inspector, agent, representative, or employee of the Inspection Service shall report, in the manner pre- Subpart E—Inauguration of In- scribed by the Administrator, all viola- spection; Official Establish- tions of the Act and noncompliance ment Numbers; Separation of with the regulations of which he has Establishments and Other Re- knowledge. quirements; Withdrawal of In- spection § 381.29 Suspension or other withdrawal of inspection service. § 381.25 Official establishment num- (a) Inspection service may be with- bers. drawn in accordance with section 18 of An official establishment number the Act and the applicable rules of shall be assigned to each establishment practice. granted inspection service. Such num- (b) During a period of withdrawal, no ber shall be used to identify all con- processing of poultry or poultry prod- tainers of inspected poultry products ucts subject to the inspection require- prepared in the establishment. An es- ments of the Act shall be carried on in tablishment shall not have more than the official establishment. However, one establishment number. any product which was inspected and passed prior to the withdrawal may be § 381.26 Separation of establishments. shipped from the official establish- Each official establishment shall be ment, provided its identity was main- separate and distinct from any other tained, and it has not become adulter- official establishment and from any ated or misbranded. unofficial establishment except an es- (c) Inspection may be suspended, re- tablishment preparing meat products voked, or terminated as provided in under the Federal Meat Inspection Act subsection 21(b) of the Federal Water or under State meat inspection. Fur- Pollution Control Act, as amended. ther, doorways, or other openings, may (d) The assignment of inspectors may be permitted between establishments be termporarily suspended, in whole or at the discretion of the Administrator in part, by the Administrator, to the and under such conditions as he may extent he determines necessary to prescribe. avoid impairment of the effective conduct of the inspection service when the § 381.27 Inauguration of service; notifi- operator of any official establishment cation concerning regulations; sta- or any subsidiary therein, or any offi- tus of uninspected poultry prod- cer, employee, or agent of any such op- ucts. erator or any subsidiary therein, act- The inspector in charge or his super- ing within the scope of his office, em- visor shall, upon or prior to the inau- ployment, or agency, threatens to forc- guration of service, inform the opera- ibly assault or fircibly assaults, intimi- tor of the establishment of the require- dates, or interferes with any inspection ments of the regulations. If the estab- service employee in or on account of

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the performance of his official duties cer, director, trustee, partner, or em- under the Act, unless promptly upon ployee, or any person with whom he is the incident being brought by an au- negotiating or has any arrangement thorized supervisor of the Inspection concerning prospective employment, is Service employee to the attention of financially interested. the operator of the establishment the (b) All inspectors are subject to stat- operator (1) Satisfactorily justifies the utory restrictions with respect to po- incident, (2) Takes effective steps to litical activities; e.g., 5 U.S.C. 7324 and prevent a recurrence, or (3) Provides 1502. acceptable assurance that there will (c) Violation of the provisions of not be any recurrences. The suspension paragraph (a) of this section or the pro- shall remain in effect until one of such visions of applicable statutes ref- actions is taken by the operator: Pro- erenced in paragraph (b) of this section vided, That upon request of the opera- will constitute grounds for dismissal in tor he shall be afforded an opportunity the case of appointees and for revoca- for an expedited hearing to show cause tion of licenses in the case of licensees. why the suspension should be termi- (d) Inspectors are subject to all appli- nated. cable provisions of law and regulations and instructions of the Department [42 FR 12416, Mar. 4, 1977] and the Food Safety and Inspection Service and other authority concerning Subpart F—Assignment and Au- employee responsibilities and conduct. thorities of Program Employ- The setting forth of certain prohibi- ees; Appeals tions in this part in no way limits the applicability of such general or other §§ 381.30–381.31 [Reserved] regulations or instructions.

§ 381.32 Access to establishments. § 381.35 Appeal inspections; how made. Any duly authorized representative Any person receiving inspection serv- of the Secretary shall have access at ice may, if dissatisfied with any deci- all reasonable times, by day or night, sion of an inspector relating to any in- whether the establishment is in oper- spection, file an appeal from such deci- ation or not, to the premises or any sion: Provided, That such appeal is filed part thereof of an establishment en- within 48 hours from the time the deci- gaged in processing poultry or poultry sion was made. Any such appeal from a products for commerce, upon presen- decision of an inspector shall be made tation of appropriate credentials. to his immediate superior having jurisdiction over the subject matter of the § 381.33 Identification. appeal, and such superior shall deter- Each inspector will be furnished with mine whether the inspector’s decision a numbered official inspection badge, was correct. Review of such appeal de- which shall remain in his or her posses- termination, when requested, shall be sion at all times, and which shall be made by the immediate superior of the worn in such manner and at such times employee of the Department making as the Administrator may prescribe. the appeal determination. The cost of This badge shall be sufficient identi- any such appeal shall be borne by the fication to entitle the inspector to ad- appellant if the Administrator deter- mittance at all regular entrances and mines that the appeal is frivolous. The to all parts of the establishment and charges for such frivolous appeal shall premises to which the inspector is as- be at the rate of $9.28 per hour for the signed. time required to make the appeal in- [59 FR 42156, Aug. 17, 1994] spection. The poultry or poultry products involved in any appeal shall be § 381.34 Financial interest of inspec- identified by U.S. retained tags and tors. segregated in a manner approved by (a) No inspector shall inspect any the inspector pending completion of an poultry or poultry product in which he, appeal inspection. his spouse, minor child, partner, orga- [48 FR 11419, Mar. 18, 1983, as amended at 60 nization in which he is serving as offi- FR 67456, Dec. 29, 1995]

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Subpart G—Facilities for Inspec- position shall not be less than 60 tion; Overtime and Holiday inches. Service; Billing Establishments (ii) Floor space shall consist of 4 feet along the conveyor line for the inspec- § 381.36 Facilities required. tor, and 4 feet for the establishment helper. A total of at least 8 feet along (a) Inspector’s Office. Office space, in- the conveyor line shall be supplied for cluding, but not being limited to fur- one inspection station and 16 feet for nishings, light, heat, and janitor serv- two-inspection stations. ice, shall be provided rent free in the (iii) Selectors or ‘‘kickouts’’ shall be official establishment, for the use of Government personnel for official pur- installed in establishments with two poses. The room or space set apart for inspection stations on a line so each in- this purpose must meet the approval of spector will receive birds on 12-inch the Inspection Service and be conven- centers with no intervening birds to iently located, properly ventilated, and impede inspection. The selector must provided with lockers or file cabinets move the bird to the edge of the trough suitable for the protection and storage for the inspector and establishment of supplies and with facilities suitable helper. The selectors must be smooth, for inspectors to change clothing. At steady, and consistent in moving the the discretion of the Administrator, birds parallel and through the inspec- small plants requiring the services of tion station. Birds shall be selected and less than one full-time inspector need released smoothly to avoid swinging not furnish facilities for Program em- when entering the inspection station. ployees as prescribed in this section, (iv) Each inspector’s station shall where adequate facilities exist in a meet the requirements specified in nearby convenient location. Each offi- § 381.53. The station shall have a plat- cial establishment shall provide com- form that is slip-resistant and can be mercial laundry service for inspectors’ safely accessed by the inspector. The outer work clothing, or disposable platform shall be designed so that it outer work garments designed for one- can be easily and rapidly adjusted for a time use, or uniform rental service gar- minimum of 14 inches vertically while ments which are laundered by the rent- standing on the platform. The platform al service. shall be a minimum length of 4 feet and (b) Facilities for ante mortem inspec- have a minimum width of 2 feet; the tion. Batteries, coops, or other facili- platform shall be designed with a 42- ties in which live poultry is presented inch high rail on the back side and for ante mortem inspection shall be of with 1⁄2-inch foot bumpers and both such arrangement and construction, sides and front to allow safe working and shall be so placed with sufficient conditions. The platform must have a light provided so that the inspector can safe lift mechanism and be large clearly see the birds to the extent enough for the inspector to sit on a needed to carry out an adequate in- stool and to change stations during spection. breaks or station rotation. (c) Facilities for the Streamlined In- (v) Conveyor line stop/start switches spection System (SIS). The following shall be located within easy reach of requirements for lines operating under each inspector. SIS are in addition to the normal re- (vi) A trough or other facilities com- quirements to obtain a grant of inspec- plying with § 381.53(g)(4) of this Part tion. The requirements for SIS in shall extend beneath the conveyor at § 381.76(b) also apply. all places where processing operations (1) The following provisions shall are conducted from the point where the apply to every inspection station: carcass is opened to the point where (i) The conveyor line shall be level the trimming has been performed. The for the entire length of the inspection trough must be of sufficient width to station. The vertical distance from the preclude trimmings, drippage, and de- bottom of the shackles to the top of bris from accumulating on the floor or the adjustable platform (paragraph platforms. The clearance between the (c)(1)(iv) of this section) in its lowest suspended carcasses and the trough

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must be sufficient to preclude contami- ing requirements for lines operating nation of carcasses by splash. under the NELS inspection system are (vii) A minimum of 200-footcandles of in addition to the normal requirements shadow-free lighting with minimum to obtain a grant of inspection and to color rendering index value of 85 1 the requirements for NELS in § 381.76 where the birds are inspected to facili- (b) and (c). tate inspection, notwithstanding the (1) The following provisions shall requirements of § 381.52(b). apply to every inspection station: (viii) ‘‘Online’’ handrinsing facilities (i) The conveyor line shall be level with a continuous flow of water con- for the entire length of the inspection forming to § 381.51(f) shall be provided station. The vertical distance from the for and within easy reach of each in- bottom of the shackles to the top of spector and each establishment helper. the adjustable platform (paragraph (ix) Hangback racks shall be provided (d)(1)(iv) of this section) in its lowest for and positioned within easy reach of position shall not be less than 60 the establishment helpers. inches. (x) Each inspection station shall be (ii) Floor space shall consist of 6 feet provided with receptacles for con- along the conveyor line for the estab- demned carcasses and parts. Such re- lishment employee presenting the ceptacles shall conform to the require- birds, 4 feet for the inspector, and 4 ments of § 381.53(m). feet for the establishment helper. A (2) The following provisions shall total of at least 42 feet along the con- apply only to prechill and postchill re- veyor line shall be supplied for three inspection stations: inspection stations. (i) Floor space shall consist of a min- (iii) Selectors or ‘‘kickouts’’ shall be imum of 3 feet along each conveyor installed so the three inspection sta- line and after each chiller to allow car- tions will receive birds on 18-inch cen- casses to be removed for evaluation. ters with no intervening birds to im- The space shall be level and protected pede inspection. The selector must from all traffic and overhead obstruc- move the bird to the end of the trough tions. for the presenter, inspector, and estab- (ii) The vertical distance from the lishment helper. The selectors must be bottom of the shackles to the floor smooth, steady, and consistent in mov- shall not be less than 48 inches. ing the birds parallel and through the (iii) A table, at least 2 feet wide, 2 inspection station. Birds shall be se- feet deep, and 3 feet high designed to be lected and released smoothly to avoid readily cleanable and drainable shall splashing the mirror (paragraph be provided for reinspecting the sam- (d)(1)(vii) of this section) and swinging pled birds. when entering the inspection station. (iv) A minimum of 200-footcandles of Guide bars shall not extend in front of shadow-free lighting with a minimum the inspection station mirror to avoid color rendering index of 85 on the table obstructing the inspector’s view. surface shall be provided. (iv) Each inspector’s station shall (v) A separate clip board holder shall have an easily and rapidly adjustable be provided for holding the recording platform, with a minimum of 14 inches sheets. of vertical adjustment, which covers (vi) Handwashing facilities shall be the entire length of the station (4 feet) provided for and shall be within easy and has a minimum width of 2 feet. The access of persons working at the sta- platform shall be designed with a 42- tions. inch high rail on the back side and (vii) Hangback racks designed to hold with 1⁄2-inch foot bumpers on both sides 10 carcasses shall be provided for and and front to allow safe working condi- positioned within easy reach of the per- tions. son at the station. (v) Conveyor line stop/start switches (d) Facilities for the New Line Speed shall be located within easy reach of (NELS) inspection system. The follow- each inspector. (vi) A trough complying with 1 This requirement may be met by deluxe § 381.53(g)(4) of this Part shall extend cool white type of fluorescent lighting. beneath the conveyor at all places

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where processing operations are con- (iii) A table, at least 3 feet wide and ducted from the point where the car- 2 feet deep, shall be provided for re- cass is opened to the point where the inspecting the sample birds. trimming has been performed. The (iv) A minimum of 200-footcandles of trough must be of sufficient width to shows free lighting with a minimum preclude trimmings, drippage, and de- color rendering index of 85 1 on the bris from accumulating on the floor or table surface. platforms. The clearance between the (v) A separate clip board holder shall suspended carcasses and the trough be provided for holding the recording must be sufficient to preclude contami- sheets. nation of carcasses by splash. (vi) Handwashing facilities shall be (vii) A distortion-free mirror, at least provided for and shall be within easy 3 feet wide and 2 feet high, shall be reach of persons working at the sta- mounted at each inspection station so tion. that it can be adjusted between 5 and (vii) Hangback racks designed to hold 15 inches behind the shackles, tilt up 10 carcasses shall be provided for and and down, tilt from side to side, and be positioned within easy reach of the per- raised and lowered. The mirror shall be son at the station. positioned in relation to the inspection (e) Facilities for the New Turkey In- platform so that the inspector can po- spection (NTI) System. The following sition himself/herself opposite it 8 to 12 requirements for lines operating under inches from the downstream edge. The the NTI System are in addition to the mirror must be maintained abrasion normal requirements to obtain a grant free. of inspection and to the requirements (viii) A minimum of 200-footcandles for the NTI System in § 381.76 (b) and of shadow-free lighting with minimum (c). color rendering index value of 85 1 (1) The following provisions apply to where the birds are inspected to facili- every inspection station: tate inspection, notwithstanding the (i) The conveyor line must be level requirement of § 381.52(b). A light shall for the entire length of the inspection also be positioned above and slightly in station. The vertical distance from the front of the mirror to facilitate the il- bottom of the shackles to the top of lumination of the bird and mirror sur- the adjustable platform (paragraph faces. (e)(1)(iii) of this section) in its lowest (ix) ‘‘One-line’’ handrinsing facilities position shall not be less than 60 with a continuous flow of water shall inches. be provided for and within easy reach (ii) Floor space shall consist of 8 feet of each inspector and each establish- along the conveyor line; at least 4 feet ment presenter and helper. for the inspector, and at least 4 feet for (x) Hangback racks shall be provided the establishment helper. for and positioned within easy reach of (iii) The inspector’s station shall the establishment helpers. have an easily and rapidly adjustable (xi) Each inspection station shall be platform with a minimum width of 2 provided with receptacles for con- feet which covers the entire length of demned carcasses and parts. Such re- the station (4 feet). The platform must ceptacles shall conform to the require- adjust vertically a minimum of 14 ments of § 381.53(m). inches, and must have a 42-inch rail on (2) The following provisions shall the back side and 1⁄2-inch foot bumpers apply only to the reinspection station: on the sides and the front to allow safe (i) Floor space shall consist of 6 feet working conditions. along the conveyor line. The space (iv) Conveyor line stop/start switches shall be level and protected from all shall be located within easy reach of traffic and overhead obstructions. each inspector. (ii) The vertical distance from the (v) A trough or other facilities com- bottom of the shackles to the floor plying with § 381.53(g)(4) shall extend shall not be less than 48 inches. beneath the conveyor at all places where processing operations are con- 1 This requirement may be met by deluxe ducted from the point where the car- cool white type of fluorescent lighting. cass is opened to the point where the

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trimming has been performed. The positioned within easy reach of the per- trough must be wide enough to prevent son at this station. trimmings, drippage, and debris from [37 FR 9706, May 16, 1972, as amended at 38 accumulation on the floor or plat- FR 9794, Apr. 20, 1973; 47 FR 23434, May 28, forms. The clearance between sus- 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, pended carcasses and the trough must Sept. 16, 1985; 52 FR 39209, Oct. 21, 1987] be sufficient to prevent contamination of carcasses by splash. § 381.37 Schedule of operations. (vi) A minimum of 200 foot-candles of (a) No operations requiring inspec- shadow-free lighting with a minimum tion shall be conducted except under color rendering index value of 85 1 the supervision of an Inspection Serv- where the birds are inspected to facili- ice employee. All eviscerating of poul- tate inspection is required. The mini- try and further processing shall be mum lighting requirement for inspec- done with reasonable speed, consider- tion stations in § 381.52(b) shall not ing the official establishment’s facili- apply. ties. (vii) On-line handrinsing facilities (b) A shift is a regularly scheduled with a continuous flow of water shall operating period, exclusive of meal- be provided for and within easy reach time. One lunch period is the only offi- of each inspector and each establish- cial authorized interruption in the in- ment helper. spector’s tour of duty once it begins. (viii) Hangback racks shall be pro- Lunch periods may be 30 minutes, 45 vided for and within easy reach of the minutes, or in any case may not exceed establishment helper. one hour in duration. Once established, (ix) Receptacles shall be provided for the lunch period must remain rel- condemned carcasses and parts con- atively constant as to time and dura- forming with the requirements of tion. Lunch periods for inspectors shall § 381.53(m). not, except as provided herein, occur (2) The following provisions shall prior to 4 hours after the beginning of apply only to the reinspection station: scheduled operations nor later than 5 (i) Floor space shall consist of a min- hours after operations begin. In plants imum of 3 feet along the conveyor line where a company rest break of not less so carcasses can be removed from each than 30 minutes is regularly observed, line for evaluation. The space shall be approximately midpoint between start level and protected from all traffic and of work and the lunch period, and the overhead obstructions. inspector is allowed this time to meet (ii) The vertical distance from the his personal needs, the lunch period bottom of the shackles to the floor may be scheduled as long as 51⁄2 hours must not be less than 48 inches. after the beginning of scheduled oper- (iii) A table at least 3 feet wide and 2 ations. feet deep designed to be readily clean- (c) Official establishments, import- able and drainable shall be provided for ers, and exporters shall be provided in- reinspecting the sampled birds. spection service, without charge, up to (iv) A minimum of 200 foot-candles of 8 hours per shift during the basic workweek subject to the provisions of shadow-free lighting with a minimum § 381.38: Provided, That any additional color rendering index of 85 1 at the shifts meet requirements as deter- table surface is required. mined by the Administrator or his des- (v) A clipboard holder shall be pro- ignee. The basic workweek shall con- vided for holding the recording sheets. sist of 5 consecutive 8-hour days within (vi) Handwashing facilities shall be the administrative workweek Sunday provided for and within easy reach of through Saturday, excluding the lunch persons working at the station. period; except that, when possible, the (vii) Hangback racks designed to hold Department shall schedule the basic 10 carcasses shall be provided for and workweek so as to consist of 5 consecutive 8-hour days Monday through Fri- 1 This requirement may be met by deluxe day, excluding lunch period. The De- cool white fluorescent lighting. partment may depart from the basic

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workweek in those cases where main- hours on any day, or more than 40 taining such a schedule would seriously hours in any administrative workweek handicap the Department in carrying Sunday through Saturday. out its functions. These provisions are (b) Holidays for Federal employees applicable to all official establishments shall be New Year’s Day, January 1; except in certain cases as provided in Birthday of Martin Luther King, Jr., § 381.145(h) of this subchapter. the third Monday in January; Washing- (d)(1) Each official establishment ton’s Birthday, the third Monday in shall submit a work schedule to the February; Memorial Day, the last Mon- area supervisor for approval. In consid- day in May; Independence Day, July 4; eration of whether the approval of an Labor Day, the first Monday in Sep- establishment work schedule shall be tember; Columbus Day, the second given, the area supervisor shall take in account the efficient and effective use Monday in October; Veterans’ Day, No- of inspection personnel. The work vember 11; Thanksgiving Day, the schedule must specify the workweek, fourth Thursday in November; Christ- daily clock hours of operation, and mas Day, December 25. When any of lunch periods for all departments of the above-listed holidays falls outside the establishment requiring inspection. the basic workweek, the nearest work- (2) Establishments shall maintain day within that week shall be the holi- consistent work schedules. Any request day. by an establishment for a change in its [40 FR 45801, Oct. 3, 1975, as amended at 43 FR work schedule involving changes in the 51754, Nov. 7, 1978; 50 FR 51513, Dec. 18, 1985; workweek or an addition or elimi- 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22, 1988; nation of shifts shall be submitted to 54 FR 6390, Feb. 10, 1989] the area supervisor at least 2 weeks in advance of the proposed change. Fre- § 381.39 Basis of billing for overtime quent requests for change shall not be and holiday services. approved: Provided, however, Minor de- (a) Each recipient of overtime or hol- viations from a daily operating sched- iday inspection service, or both, shall ule may be approved by the inspector in charge if such request is received on be billed as provided for in § 381.38(a) the day preceding the day of change. and at the rate specified in § 391.3, in (3) Requests for inspection service increments of quarter hours. For bill- outside an approved work schedule ing purposes, 8 or more minutes shall shall be made as early in the day as be considered a full quarter hour. Bill- possible for overtime work to be per- ing will be for each quarter hour of formed within that same workday; or service rendered by each Inspection made prior to the end of the day’s oper- Service employee. ation when such a request will result in (b) Official establishments, import- overtime service at the start of the fol- ers, or exporters requesting and receiv- lowing day: Provided, That an inspector ing the services of an Inspection Serv- may be recalled to his assignment after ice employee after he has completed the completion of his daily tour of duty his day’s assignment and left the prem- under the provisions of § 381.39(b). ises, or called back to duty during any [40 FR 45800, Oct. 3, 1975, as amended at 40 FR overtime or holiday period, shall be 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; billed for a minimum of 2 hours over- 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, time or holiday inspection service at 1986] the established rate. § 381.38 Overtime and holiday inspec- (c) Bills are payable upon receipt and tion service. become delinquent 30 days from the date of the bill. Overtime or holiday in- (a) The management of an official es- spection will not be performed for any- tablishment, an importer, or an exporter shall reimburse the Program, at one having a delinquent account. the rate specified in § 391.3, for the cost [40 FR 45801, Oct. 3, 1975, as amended at 54 FR of the inspection service furnished on 6390, Feb. 10, 1989] any holiday specified in paragraph (b) of this section; or for more than 8

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Subpart H—Sanitation (c) Rooms for holding carcasses for further inspection. Rooms or other accept- § 381.45 Minimum standards for sani- able facilities in which carcasses or tation, facilities, and operating pro- parts thereof are held for further in- cedures in official establishments. spection shall be in such numbers and The provisions of §§ 381.46 and 381.61, such locations as the needs of the in- inclusive, and part 416 of this chapter spection in the establishment may re- shall apply with respect to all official quire. These rooms or facilities shall be establishments. equipped with hasps for locking. (d) Coolers and freezers. Coolers and [61 FR 38866, July 25, 1996] freezers shall be of such size and capac- § 381.46 Buildings. ity as are required for compliance with the provisions set forth in § 381.66. (a) The buildings shall be of General. Freezing rooms, other than those for sound construction and kept in good plate freezers or liquid freezing, shall repair. have forced air circulation, and freez- (b) Outside openings. (1) The doors, ers and coolers shall be equipped with windows, skylights, and other outside floor racks, pallets or other means openings of the plant, except in receiv- which will assure that the poultry ing rooms and feeding rooms, shall be products will not be adulterated. protected by properly fitted screens or other suitable devices against the en- (e) Rooms for mechanical deboning of trance of flies and other insects. raw poultry. Rooms or compartments where mechanical equipment for (2) Outside doors, except in receiving deboning of raw poultry is operated rooms and feeding rooms, shall be so shall be maintained at 50 °F. or less. hung as to be close fitting when closed. Doors shall be provided with self-clos- (f) Storage and supply rooms. The storing devices where necessary to prevent age and supply rooms shall be kept in the entry of vermin into processing and good repair, dry, orderly, and sanitary. storage rooms. (g) Boiler room. The boiler room shall be a separate room where necessary to § 381.47 Rooms and compartments. prevent dirt and objectionable odors entering from it into any room where (a) General. Rooms or compartments used for edible poultry products shall dressed poultry or other poultry prod- be separate and distinct from inedible ucts are processed, otherwise handled, products departments and from rooms or stored. where live poultry is held or slaugh- (h) Toilet rooms. Toilet rooms, open- tered. Separate rooms shall be provided ing directly into rooms where poultry when required for conducting process- products are exposed shall have self- ing operations in a sanitary manner; closing doors and shall be ventilated to and all rooms shall be of sufficient size the outside of the building. to permit the installation of the nec- (i) Lunch rooms. Lunches and snacks essary equipment for processing oper- shall not be eaten in processing, pack- ations and the conduct of such oper- ing, or supply rooms. If needed, sepa- ations in a sanitary manner. rate rooms or areas shall be provided in (b) Refuse rooms. A separate refuse establishment where employees eat room, or other equally adequate facili- their lunches. ties, shall be provided in official establishments where accumulations of § 381.48 Floors, walls, ceilings, etc. refuse occur. Refuse rooms shall be en- (a) Floors. All floors in rooms where tirely separate from other rooms in the exposed poultry products are processed establishment, have tight-fitting doors, or handled shall be constructed of, or be properly ventilated, and have ade- finished with, materials impervious to quate drainage and cleanup facilities, moisture, so they can be readily and and the floors and walls to a height of thoroughly cleaned. The floors in kill- 6 feet above the floor shall be imper- ing, ice cooling, ice packing, eviscerat- vious to moisture, and walls above that ing, cooking, boning, and cannery height, and ceilings shall be moisture rooms shall be graded for complete resistant. runoff with no standing water.

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(b) Walls, posts, partitions, doors. All bottoms and be provided with suitable walls, posts, partitions, and doors in covers. rooms where exposed poultry products (3) Each floor drain shall be equipped are processed or otherwise handled with a deep seal trap, and the plumbing shall be smooth and constructed of ma- shall be installed so as to prevent sew- terials impervious to moisture to a age from backing up and flooding the height of 6 feet above the floor to en- floor, except that floor drains in areas able thorough cleaning. All surfaces not regularly washed down will be ac- above this height must be smooth and ceptable without deep seal traps: Pro- finished with moisture-resistant mate- vided, That such drains are connected rial. to secondary drainage systems dis- (c) Ceilings. Ceilings must be mois- charging into a safe sink or basin (air ture resistant in rooms where exposed gap) that is properly trapped and vent- poultry products are processed or oth- ed: And provided further, That such erwise handled, and finished and sealed drains accomplish the objectives and to prevent collection of dirt or dust intent of this paragraph. that might sift through from the floor (4) Toilet soil lines shall be separate above or fall from collecting surfaces from house drainage lines to a point on equipment or exposed poultry prod- outside the buildings unless an auto- uct. matic backwater check valve is installed to prevent backflow. Drainage § 381.49 Drainage and plumbing. from toilet bowls and urinals shall not be discharged into a grease catch basin, (a) General. There shall be an effi- nor shall such drainage be permitted to cient draining and plumbing system for enter the sewer lines at a point where the plant and premises. there might be a possibility of such (b) Outside premises. The drainage sys- drainage backing up and flooding the tem must permit the quick runoff of all floor of the building. water from buildings, and of surface water around the official establishment § 381.50 Water supply. and on the premises; and all such water (a) General: Except as provided in shall be disposed of in such a manner paragraph (e) of this section, the water as to avoid the development of insani- supply shall be ample, clean, and pota- tary conditions at the establishment. ble with adequate pressure and facili- (c) Drainage of sewage and plant ties for its distribution in the official wastes. (1) All drains and gutters shall establishment and its protection be properly installed with approved against contamination and pollution. A traps and vents. The sewer system water report, issued under the author- shall have adequate slope and capacity ity of the State health agency, certify- to remove readily all waste from the ing to the potability of the water sup- various processing operations and to ply, shall be obtained by the applicant minimize or, if possible, prevent stop- and furnished to the Administrator page and surcharging of the system. whenever such report is required by the When the sewage disposal system is a Administrator in specific cases. private system which is required to be (b) An adequate supply of hot water approved by a State or local health au- to enable proper cleaning shall be thority, the applicant shall furnish the available. Administrator a letter from the proper (c) Hose connections with steam and health authority indicating that the water mixing valves or hot water hose sewage disposal system is acceptable to connections shall be provided at con- such authority. venient locations throughout the plant (2) Interceptor traps which are con- for cleaning purposes. nected with the sewer system shall be (d) The refuse rooms shall be pro- suitably located, and not near any edi- vided with adequate facilities for wash- ble poultry products department or in ing refuse cans and other equipment in any area where edible poultry products the rooms. are unloaded from or loaded into any (e) Nonpotable water is permitted means of conveyance. To facilitate only in those parts of official establish- cleaning, such traps shall have inclined ments where no poultry product is

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processed or otherwise handled and wearing apparel, and for the storing then only for limited purposes such as and changing of clothing. Wearing ap- on condensers not connected with the parel shall not be stored in rooms potable water supply, in vapor lines where processing operations are con- serving inedible product rendering ducted. tanks, and in sewerlines for moving (d) Suitable containers shall be pro- heavy solids in the sewage. Nonpotable vided for the temporary storage of water is not permitted for washing soiled linen, coats, aprons, and other floors, areas, or equipment, nor is it items of employees’ uniforms or work permitted in boilers, scalders, chill clothing. vats, or icemaking machines. In all (e) Sufficient containers of metal or cases, nonpotable water lines shall be other acceptable impervious material clearly identified and shall not be cross shall be provided for used towels and connected with the potable water sup- other wastes. ply unless this is necessary for fire pro- (f) An adequate number of hand tection. Any such connection must washing facilities shall be provided in have an adequate break to assure areas where poultry products are pre- against accidental contamination, and pared. Hand washing facilities accepted must be approved by local authorities in accordance with the procedures set and by the Administrator. Any forth in § 381.53 may be used in such untested water supply in an official es- areas, provided that if hand-activated tablishment shall be treated as a non- facilities are used, the hand-contact potable supply. element must be rinsed automatically (f) The circuit supervisor may permit with a sufficient volume of water to re- the reuse of water in equipment where move all fat, tissue, debris, and other such water is used to thermally process extraneous material from the hand canned product packed in hermetically contact element after each use. Both sealed containers, provided: hot and cold running water shall be (1) The reuse is for the identical available at each inspection station on original purpose. the eviscerating line and shall be deliv- (2) All pipelines, reservoirs, tanks, ered through a suitable mixing device cooling towers, and like equipment em- controlled by the inspector. Alter- ployed in handling the reused water are natively, water for hand washing shall so constructed and installed so they be delivered to such inspection stations can be cleaned and drained, and are at a minimum temperature of 65 °F. kept clean. (g) Durable signs shall be posted con- [37 FR 9706, May 16, 1972, as amended at 51 spicuously in each toilet room and FR 45633, Dec. 19, 1986] locker room directing employees to wash their hands before returning to § 381.51 Lavatories, toilets, and other work. sanitary facilities. (h) Adequate toilet facilities shall be (a) Modern lavatory and toilet ac- provided and the following formula commodations and properly located fa- shall serve as a basis for determining cilities for cleaning utensils and hands the number of toilet bowls required: shall be provided. Minimum (b) Adequate lavatory and toilet ac- number commodations, including but not being Number of persons of same sex of facili- limited to, running hot and cold water, ties soap, or other acceptable agents (in 1 to 9 ...... 1 sanitary dispensers), toilet tissue, and 10 to 24 ...... 2 25 to 49 ...... 3 towels or other acceptable facilities for 50 to 74 ...... 4 drying hands, shall be provided. Lava- 75 to 100 ...... 5 tories shall be in or near toilet and Over 100 ...... (1) locker rooms and also at other places 1 1 for each additional 30 persons. in the plant as may be essential to the Where 10 or more are employed, urinals cleanliness of all personnel handling may be substituted for the toilet bowls speci- poultry products. fied in the foregoing formula, except that the (c) Adequate lockers or other facili- number of toilet bowls in such cases may not ties, shall be provided for employees’ be reduced to less than two-thirds of the

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number specified. Two feet of trough urinal tinctive marking to identify them as shall be considered as equivalent to one indi- only for such use and shall not be used vidual urinal. for handling any edible poultry prod- (i) Suitable sanitary drinking water ucts. facilities shall be provided. (2) When equipment or utensils for (j) All toilets, lavatories, and other use in preparing or handling product sanitary facilities shall be kept clean are proposed for use in an official es- and in good repair. tablishment, the operator of the establishment shall so notify the Adminis- [37 FR 9706, May 16, 1972, as amended at 41 FR 6752, Feb. 13, 1976] trator, and thereafter shall submit to the Administrator such information as § 381.52 Lighting and ventilation. the Administrator specifies in each (a) There shall be ample light, either case as necessary to determine whether natural or artificial or both, of good the equipment or utensils meet the cri- quality and well distributed, and suffi- teria specified in paragraph (a)(1) of cient ventilation for all rooms and this section. The required information compartments to insure sanitary con- shall include, but may not be limited ditions. to, assembly type drawings and a list (b) All rooms in which poultry is showing the materials of which parts killed, eviscerated, or otherwise proc- are made. The Administrator will essed shall have at least 30 foot-candles evaluate the model of equipment or of light intensity on all working sur- utensil and determine whether it is ac- faces, except that at the inspection sta- ceptable for its proposed use under the tions such light intensity shall be of 50 criteria set forth in paragraph (a)(1) of foot-candles. In all other rooms there this section. shall be provided at least 5 foot-candles (3) The Administrator will, from time of light intensity when measured at a to time, prepare a listing by name and distance of 30 inches from the floor. model number of equipment and uten- (c) All rooms shall be adequately sils that have been evaluated and found ventilated to eliminate objectionable to be acceptable for their proposed use odors and minimize moisture condensa- in accordance with this section. A copy tion. of such listing can be obtained from Technical Services, Meat and Poultry § 381.53 Equipment and utensils. Inspection Program, Food Safety and (a)(1) Equipment and utensils used Inspection Service, U.S. Department of for processing or otherwise handling Agriculture, Washington, DC 20250. any edible poultry product or ingredi- (4) The Administrator may dis- ent thereof, in any official establish- approve for use in official establishment shall comply with any applicable ments particular models of equipment provisions of paragraphs (c) through or utensils that he finds do not meet (m) of this section and otherwise shall the requirements of paragraph (a)(1) of be of such material and construction this section, or that he cannot evaluate as, in the judgment of the Adminis- because of lack of sufficient informa- trator, will facilitate their thorough tion. Further, he may prescribe such cleaning and insure cleanliness in the conditions for the use of particular preparation and handling of all edible models of equipment or utensils, either poultry products and avoid adultera- on a trial or permanent basis, as he tion and misbranding of such products. finds necessary to prevent adulteration In addition to these requirements, or misbranding of product. equipment and utensils shall not in (5) Nothing in this section shall af- any way interfere with or impede in- fect the authority of Inspection Service spection procedures. Receptacles used inspectors to reject specific equipment for handling inedible products shall be or utensils under § 381.99 of the regula- of such material and construction that, tions in this subchapter. in the judgment of the Administrator, (b) Before approval of any model or their use will not result in adulteration specific item of equipment or utensil is of any edible product or in unsanitary finally denied, or is granted only with conditions at the establishment, and conditions, the applicant shall be given they shall bear conspicuous and dis- notice and opportunity to present his

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views to the Administrator. If the ap- all parts thereof in a way that will per- plicant does not accept the Adminis- mit adequate and efficient inspection. trator’s determination, a hearing in ac- (2) Overhead conveyors shall be so cordance with the applicable rules of constructed and maintained that they practice will be held to resolve such will not allow grease, oil, or dirt to ac- dispute. This shall not preclude rejec- cumulate on the drop chain or shackle, tion of the equipment or utensils under which shall be of noncorrosive metal. § 381.99 or this section pending the out- (3) Nonmetallic belt-type conveyors come of the presentation of views or used in moving poultry products shall hearing. be of waterproof composition. (c) Refuse containers. Leakproof (4) When eviscerated on a conveyor, refuse containers with covers shall be each carcass shall be suspended and a provided, except that perforated con- trough or other acceptable facilities tainers may be used for the temporary for maintaining proper sanitation shall collection of feathers and such contain- be provided beneath the conveyor. ers need not be covered. Such troughs or other facilities shall (d) Scalding equipment. (1) Scalding be flushed or cleaned in an acceptable tanks shall be constructed and in- manner and shall extend beneath the stalled so as to prevent contamination conveyor at all places where processing of potable water lines and to permit operations are conducted from the water to enter continuously at a rate point where the carcass is opened to which will result in a sanitary scalding the point where the viscera have been operation. The rate of flow necessary completely removed. to maintain a sanitary scalding oper- (h) Chilling and thawing tanks. ation will be determined on such fac- Chilling and thawing tanks shall be tors as the class of poultry and the constructed of metal or other suitable number of birds per minute going into material impervious to moisture and the scalding tank. It shall be the re- shall be of sanitary construction with sponsibility of the inspector in charge edges rolled outward. Where mechani- to establish a minimum rate of flow for cal devices are not used for removing each scalding tank in each official es- carcasses from the chilling or thawing tablishment. tanks, the tanks shall be of a size that (2) The overflow outlets in scalding will enable employees to remove poul- equipment shall be of sufficient size to try without entering the tanks. permit feathers and water to be carried (i) Tables. Inspection, eviscerating, off. and cutting tables shall be made of (3) The overflow, drawoff valves, and metal or other acceptable material, sediment basin drain shall discharge have coved corners, and be constructed into a floor or valley drain, or onto the and placed so as to permit thorough floor in proximity to a floor or valley cleaning. drain. (j) Plants lacking conveyors. In (e) Wax finishing. When wax dipping plants where no conveyors are used, is used, metal troughs shall be provided each carcass shall be eviscerated in an to catch the wax removed from the individual metal tray of seamless con- dipped poultry. Acceptable facilities struction or in a tray of other accept- and methods shall be employed in re- able material and construction. claiming the wax. (k) Water spray washing equipment. (f) Ice shovels. Ice shovels shall be Water spray washing equipment with smooth surfaced and entirely con- sufficient water pressure to thoroughly structed of rustproof, impervious mate- and efficiently wash carcasses shall be rial. used for washing carcasses inside and (g) Conveyors. (1) Conveyors used in out. the preparation of ready-to-cook poul- (l) Offal receptacles. Watertight re- try shall be of metal or other accept- ceptacles constructed of metal or other able material and of such construction acceptable impervious material shall as to permit easy identification of the be used for entrails and other waste re- viscera with their carcass and so de- sulting from preparation of eviscerated signed as will present each carcass or poultry.

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(m) Receptacles for condemned car- nonfood processing equipment and ma- casses. Watertight receptacles for hold- chinery, and any replacement parts for ing or handling condemned carcasses or such equipment and machinery, totally parts of carcasses shall be so con- enclosed capacitors containing less structed as to be readily and thor- than 3 pounds of PCBs are exempted oughly cleaned; such receptacles shall from this prohibition. be marked in a conspicuous manner with the words ‘‘U.S. Condemned’’ in [37 FR 9706, May 16, 1972, as amended at 45 FR 68918, Oct. 17, 1980] letters not less than 2 inches high and when required by the inspector in § 381.57 Cleaning of rooms and com- charge, shall be equipped with facili- partments. ties for locking and sealing. Rooms, compartments, and other [40 FR 60053, Dec. 31, 1975] parts of the official establishment shall be kept clean and in sanitary condition § 381.54 Accessibility of equipment. and good repair. (a) General. All equipment shall be placed so as to be readily accessible for § 381.58 Cleaning of equipment and all processing and cleaning operations. utensils. (b) Mechanical pickers. When mechan- (a) Equipment and utensils used for ical pickers are used, they shall be in- processing or otherwise handling any stalled so as to be accessible for thor- poultry or poultry product shall be ough cleaning and removal of the accu- kept clean, sanitary, and in good re- mulation of feathers. pair. (b) Batteries and dropping pans shall § 381.55 Restrictions on use of equipment and utensils. be cleaned regularly and the manure removed from the official establish- Equipment and utensils used in the ment daily. official establishment shall not be used (c) Scalding tanks shall be com- outside the official establishment, ex- pletely emptied and thoroughly cept under conditions prescribed or ap- cleaned as often as may be necessary, proved by the Administrator in specific but not less frequently than once a day cases. Equipment used in the prepara- when in use. tion of any article (including, but not (d) All equipment and utensils used limited to, animal food), from inedible in the killing, roughing, and pinning material shall not be used outside of rooms shall be thoroughly washed and the inedible products department ex- cleaned at least once daily when in use. cept under such conditions as may be (e) The chilling and packing room prescribed or approved by the Adminis- and equipment and utensils used there- trator in specific cases. in shall be maintained in a clean and § 381.56 Maintenance of sanitary con- sanitary condition. ditions and precautions against (f) Chilling or thawing tanks shall be contamination of poultry products; emptied after each use. They shall be PCB–containing equipment. thoroughly cleaned at least once daily (a) The premises of the official estab- when in use, except that when the lishment shall be kept free from refuse, same poultry is held therein in excess waste materials, and all other sources of 24 hours, the tanks shall be thor- of odors and conditions that may result oughly cleaned after the poultry is rein adulteration of the poultry products moved therefrom and prior to reuse. handled at the establishment. (g) Conveyor trays or belts which (b) New or replacement equipment or come in contact with raw poultry prod- machinery (including any replacement ucts shall be completely washed and parts) brought onto the premises of sanitized after each use. any official establishment shall not (h) Tables, shelves, bins, trays, pans, contain liquid polychlorinated knives, and all other tools and equip- biphenyls (PCBs) in concentrations ment used in the processing of poultry above 50 parts per million by weight of products shall, after cleaning, be the liquid medium. This provision ap- drained on racks and trays and pans plies to both food processing and shall not be nested.

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§ 381.59 Vermin. (b) As a prerequisite for approval, any compound which is required to be Every practicable precaution shall be registered under the provisions of the taken to exclude flies, rats, mice, and Federal Insecticide, Fungicide, and other vermin from the official estab- Rodenticide Act shall be registered and lishment. Dogs, cats, and other pets comply with the provisions of that Act. shall be excluded from rooms where The applicant shall furnish the reg- dressed poultry or other poultry prod- istration number assigned under the ucts are processed, handled, or stored. aforesaid Act along with two copies of § 381.60 Use of compounds. the label being currently used on the product. Germicides, insecticides, rodenti- (c) A small sample of the compound cides, detergents, or wetting agents or (4 to 6 ounces) shall be submitted with other similar compounds may be used the request for approval of its use in in an official establishment only if poultry processing establishments. they will not deleteriously affect the (d) The Administrator will either ap- poultry or poultry products therein prove or disapprove the use of a par- and have been approved by the Admin- ticular compound after a careful eval- istrator. Such compounds shall be used uation of the data submitted pursuant only in a manner satisfactory to the to paragraph (a) of this section and Administrator. Such compounds shall consideration of any other information be approved, for the purpose of the Act that is available pertaining to the only upon application and in accord- compound under consideration. ance with the following procedure: (e) The Inspection Service is author- (a) The manufacturer or user of the ized to draw samples of any compound compound, or any other interested per- used in any official establishment and son, shall submit to the Administrator make analyses of such compound to de- the following data: termine if the compound conforms to (1) The formula of the compound, that originally approved and if it is listing each ingredient and the percent- satisfactory for use in official estab- age of each ingredient in terms of lishments under this section. Whenever weight or liquid measure, if the prod- the Administrator has reason to be- uct is a liquid, and in terms of weight, lieve that a compound may have a dele- if it is solid or semisolid, viscous, or a terious effect on poultry or poultry mixture of liquid and solids. The ingre- products, the approval of the particular dients must be stated in terms of the compound may be suspended, and in well-known common names of the in- such case the processor shall be given gredients or if an ingredient has no an opportunity to show that the common name, the correct chemical compound does not have such effect. name. However, in the case of any After such opportunity has been af- compound subject to the Federal Insec- forded to the processor, the Adminis- ticide, Fungicide, and Rodenticide Act, trator shall make a determination as a statement of the composition of the to the effect of the compound on poul- compound as required for registration try and poultry products and withdraw under that Act shall be submitted in or reinstate the approval of the lieu of the data otherwise required by compound accordingly. Use of the this subparagraph. compound shall not be permitted dur- (2) A certification by the applicant ing the period of suspension. that the compound as it is proposed to be used in the official establishment § 381.61 Cleanliness and hygiene of of- will not deleteriously affect the poul- ficial establishment personnel. try or poultry products therein. The (a) No official establishment shall certification shall include the condi- employ, in any department where any tions under which the particular poultry product is processed or other- compound is believed to be satisfactory wise handled, any person showing evi- for use and the precautions, if any, nec- dence of a communicable disease in a essary in the use of such compound for transmissible stage or known to be a the purpose intended in poultry proc- carrier of such disease, or while af- essing establishments. fected with boils, sores, infected

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wounds, or other abnormal sources of after the inspectors complete their microbiological contaminants. post-mortem inspection of the poultry (b) All persons coming in contact viscera, but before completion of the with exposed poultry products, or poul- eviscerating operations, and shall not try products handling equipment shall be used for human food. wear clean garments and suitable head (e)–(g) [Reserved] coverings to prevent hair from falling (h) Thawing poultry in water: into poultry products; and shall keep (1) Ready-to-cook poultry. When frozen their hands and fingernails clean at all ready-to-cook poultry is to be thawed times while thus engaged. in water, the thawing practices and (c) Every person shall wash his hands procedures shall be such as will prevent thoroughly after each use of toilet or the product from becoming adulterated change of garments before returning to by the absorption of moisture and such duties that require the handling of poultry shall be thawed by one of the dressed poultry or other poultry prod- following methods: ucts or containers thereof, or poultry (i) The poultry may be thawed in product handling equipment. continuous running tap water of suffi- (d) The use of tobacco in any form, cient volume and for such limited time the eating of food, or any other per- as is necessary to thaw such poultry. sonal habit which may result in adul- The thawing media shall not exceed 70 teration of any poultry product shall °F. in temperature. Complete thawing not be permitted in any room where ex- is necessary to permit thorough exam- posed dressed poultry or other poultry ination of ready-to-cook poultry prior products are being processed or other- to any further processing. wise handled. (ii) The practice of placing frozen ready-to-cook poultry into cooking Subpart I—Operating Procedures kettles, without prior thawing, is permitted only when a representative § 381.65 Operations and procedures, sample of the entire lot has been generally. thawed and found to be sound and un- (a) Operations and procedures involv- adulterated. Thawing may be accom- ing the processing, other handling, or plished in cookers where the water can storing of any poultry product shall be be heated to enable the cooking process strictly in accord with clean and sani- to begin immediately following com- tary practices and shall be conducted pletion of thawing. Thawing practices in such a manner as will result in sani- and procedures shall result in no net tary processing, proper inspection, and gain in weight over the frozen weight. the production of poultry and poultry When whole carcasses or parts are products that are not adulterated. thawed for repackaging as parts, it is (b) Materials which create any condi- not acceptable to recool the parts in tion that may result in adulteration of slush ice. However, they may be held in poultry products shall not be handled tanks of crushed ice with the drains or stored in rooms, compartments, or open, pending further processing or other places in any official establish- packaging. ment where any poultry product is (iii) The poultry may be thawed in processed, otherwise handled, or recirculated water, maintained at a stored. temperature not in excess of 50 °F., for (c) Poultry shall be slaughtered in such limited time as is necessary to accordance with good commercial prac- thaw such poultry. tices in a manner that will result in (2) [Reserved] thorough bleeding of the carcasses and (i) Cuts for the removal of the viscera assure that breathing has stopped prior shall be limited to those necessary for to scalding. Blood from the killing op- proper processing operations and in- eration shall be confined to a rel- spection. With respect to roaster-style atively small area. evisceration, opening cuts shall be (d) Kidneys of mature chickens and made in such a manner that the skin mature turkeys (poultry defined in between the thighs and rib cage will § 381.170(a) (1)(vi) and (vii) and (2)(iv)) not be cut or torn open during the shall be removed from their carcasses drawing operation. No additional cuts

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shall be made prior to chilling other products and of sufficient strength and than those necessary to perform the durability to protect the products ade- complete evisceration of the bird. The quately during normal distribution. ‘‘bar-cut’’ method of evisceration may (o) Paper and other material used for be used only when permitted by the in- lining barrels or other containers in spector in charge upon his determina- which poultry products are packed tion that this method can be used at shall be of such kinds as do not tear the official establishment without con- readily during use but remain intact taminating the poultry. With respect when moistened by the products. Wood- to poultry that is to be opened by the en containers to be used for packing ‘‘bar-cut’’ method, particular care shall poultry products shall be fully lined ex- be exercised in making transverse cuts cept when the poultry products to be so that the thigh areas will not be packed therein are fully wrapped. opened and the flesh at the posterior (p) Protective coverings shall be used end of the keel will not be exposed. An for poultry products while they are in occasional bird that is unintentionally any official establishment or are being opened in the aforesaid areas will be permitted. The type of opening cut is transported between official establish- part of the chilling procedure and any ments, which are adequate to protect change in such cut requires establish- the products against contamination by ing a new procedure under § 381.66. any foreign substances (including, but (j) The area at the junction of the not being limited to, dust, dirt, and in- neck with the body of the eviscerated sects) considering the means employed bird shall be positively opened prior to in transporting the products. final washing so that water will drain (q)(1) Detached ova may be collected freely from the body cavity and not be- for human food in the official estab- come trapped in the area between the lishment provided it is done in a sani- neck skin and the neck. tary manner: Provided, The identity of (k) Ready-to-cook poultry shall be such ova with the carcass shall be adequately drained after chilling, to maintained past the point of inspection remove ice and free water prior to and ova from condemned carcasses packaging or packing. shall likewise be condemned and treat- (l) Cut-up poultry shall be processed ed as required in § 381.95: And provided from chilled carcasses and the parts further, That ova for human food are shall not be rechilled in ice and water cooled, packaged, and otherwise han- or water, but may be temporarily held dled so as to be fit for human food. in containers of crushed ice which are (2) Detached ova harvested for human continuously drained pending further food may leave the official establish- processing and packaging. Upon ap- ment only for movement to an egg proval by the Administrator, and under products processing plant for process- such conditions as he may prescribe in ing as allowed in § 59.440 of the regula- specific cases, cut-up poultry may be tions (7 CFR 59.440) under the Egg processed from unchilled eviscerated Products Inspection Act and when poultry. Such poultry parts shall not moved from the official establishment be chilled in water and ice, but may be shall bear labeling which indicates that chilled either in ice in continuously the ova were harvested under sanitary drained containers or by immediate supervision of the Inspection Service. entry into a freezer. Such poultry parts shall be chilled as provided in [37 FR 9706, May 16, 1972, as amended at 40 § 381.66(b)(2). FR 42338, Sept. 12, 1975; 49 FR 3643, Jan. 30, (m) All offal resulting from the evis- 1984] ceration operation shall be removed from the official establishment as § 381.66 Temperatures and chilling and freezing procedures. often as necessary to prevent the development of an insanitary condition. (a) General. Temperatures and proce- (n) Containers to be used for packag- dures which are necessary for chilling ing poultry products shall be clean, and freezing ready-to-cook poultry, in- free from substances and odors that cluding all edible portions thereof, would result in adulteration of the shall be in accordance with operating

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procedures which insure the prompt re- uous chillers shall not be used unless a moval of the animal heat and will pre- recording thermometer, with a 24-hour serve the condition and wholesomeness recording cycle, is provided to measure of the poultry and assure that the prod- the temperature in the warmest part of ucts are not adulterated. A description the chilling system. The temperature of the chilling and freezing procedures recorder shall be readily accessible. used at the official establishment shall The completed temperature charts be filed with the inspector in charge at shall be furnished daily to the inspec- the establishment. tor. (b) General chilling requirements. (1) (ii) With respect to continuous All poultry that is slaughtered and chilling systems, the fresh water in- eviscerated in the official establish- take in the first section of the system, ment shall be chilled immediately after all sections of the system are after processing so that the internal filled with water, shall be not less than temperature is reduced to 40 °F. or less, one-half gallon per frying chicken and as provided in paragraph (b)(2) of this proportionately more for other classes section unless such poultry is to be fro- of poultry, including not less than 1 zen or cooked immediately at the offi- gallon per turkey. Sufficient water or cial establishment. Eviscerated poultry ice, or both, shall be added to sections to be shipped from the establishment in packaged form shall be maintained of the chilling system other than the at 40 °F. or less, except that during fur- first section, to keep the chilling ther processing and packaging oper- media clean and to provide a continu- ations, the internal temperature may ous overflow from each section. If there rise to a maximum of 55 °F.: Provided, is no loss of water between sections, That immediately after packaging, the multiple section chilling systems may poultry is placed under refrigeration at be connected so the overflow from sub- a temperature that will promptly lower sequent sections serves as water intake the internal temperature of the prod- for the first section. In this type of in- uct to 40 °F. or less, or the poultry is stallation, the required minimum fresh placed in a freezer. Poultry which is to water intake may be either in the first be held at the plant in packaged form or the last section of the chilling sys- in excess of 24 hours shall be held in a tem. Water used to fill chilling systems room at a temperature of 36 °F. or less. shall not be counted toward minimum (2) Poultry carcasses, and major por- requirements specified in this para- tions of carcasses as defined in paragraph (c)(2)(ii). Continuous chillers graph (c)(2)(iv) of this section shall be shall not be used unless the required chilled to 40 °F. or lower within the minimum fresh water intake is meas- times specified below: ured through a meter which gives cumulative readings, and the meter shall Time be readily accessible. Upon approval by Weight of carcass (hours) the Administrator in specific cases, Under 4 pounds ...... 4 when the official establishment em- 4 to 8 pounds ...... 6 ploys an acceptable method of deter- Over 8 pounds ...... 8 mining the amount of ice added to the (c) Ice and water chilling. (1) Only ice appropriate section of the chilling sys- produced from potable water may be tem, meltage from such ice may be used for ice and water chilling. The ice counted toward the required minimum shall be handled and stored in a sani- fresh water intake. tary manner. If of block type, the ice (iii) In continuous chillers, whenever shall be washed by spraying all sur- the elevators or conveyors removing faces with clean water before crushing. the poultry from the chilling units are (2)(i) The temperature of the chilling stopped, the agitation, either mechani- media in the warmest part of any poul- cal or by air, must also be stopped. In try chilling system shall not exceed 65 addition, unless the termperature of °F. or the maximum temperature speci- the chilling media is lowered to and fied in the current chilling procedure maintained at 40 °F. or below, poultry filed as required by paragraph (a) of shall not be left in such stopped this section, whichever is less. Contin- chillers in excess of 15 minutes.

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(iv) Partial trimming and salvage of suitable operation; point of exit from parts of poultry carcasses often result the chilling units of water to be recon- in parts of major size, either front or ditioned; point of entry into the rear portions, wherein the major por- chilling units of the reconditioned tion of the poultry carcass remains in- water; frequency of filter changes, tact. These portions may be chilled in back-flushing, or other system restora- water and ice, including chilling in tion; post-filter treatment; and any continuous chillers. Individual parts other condition the alteration of which from salvage operations, including but could affect the effectiveness of recon- not limited to drumsticks, thighs, split ditioning; and carcasses, and split breasts, shall not (B) Data demonstrating that recondi- be cooled in water and ice, but may be tioning results in achieving and main- cooled in the air, or ice, or under a spray of water with continuous drain- taining throughout the operating shift age. at least a 60 percent reduction in total (v) Previously chilled poultry car- micro-organisms, that such reduction casses and major portions shall not be relates within û10 percentage points to rechilled in ice and water, but may be a similar reduction in any coliforms,1 rechilled with ice in continuously Esherichia coli 2 and/or Salmonella spp. 3 drained containers. that may be present; and that light (vi) Any owner or operator of an offi- transmission of the treated water is cial establishment desiring to utilize a maintained throughout the operating chilling system which includes water shift at no less than 60 percent of that reconditioning may, by submitting the of the fresh water supply. information and data specified in para- (3) Previously chilled poultry car- graphs (c)(2)(vi) (A) and (B) of this sec- casses and major portions shall be tion, request the Administrator to maintained constantly at 40 °F. or evaluate the efficacy of the water re- below until removed from the vats or conditioning system to determine tanks for immediate packaging. Such whether a reduction in fresh water in- products may be removed from the vats take requirements will be permitted: or tanks prior to being cooled to 40 °F. Provided, That the equipment related or below, for freezing or cooling in the to the systems has been approved official establishment. Such products under § 381.53 of Subpart H of this sub- shall not be packed until after they chapter, that operation of the system ° results in full compliance with the Act have been chilled to 40 F. or below, ex- and this subchapter, and that the sys- cept when the packaging will be fol- tem permits effective and efficient lowed immediately by freezing at the monitoring. The Administrator shall official establishment. approve requests in accordance with the following standard: 1 Five tube most probable number (MPN) following procedures in Microbiology Lab- Gallons of Minimum recondi- oratory Guidebook, FSIS, USDA, January Percent 1974, Section 3.4 using 5 replicate tubes of Minimum Percent reduction of light trans- tioned water micro-organisms in treated to replace each dilution; and computed using standard water mission in one gallon treated of fresh MPN tables. water water 2 Five tube most probable number (MPN) using procedure in Microbiology Laboratory 60 ...... 60 1.75 Guidebook, FSIS, USDA, January 1974, Sec- 70 ...... 70 1.50 tion 3.5 using 5 replicate tubes of each dilu- 80 ...... 80 1.35 90 ...... 80 1.25 tion; and computed using standard MPN ta- 98 ...... 80 1.10 bles. 3 Most probable number (MPN) per 100 ml Requests for approval must include: by 3 tube MPN. To each of three 100, 10, 1, (A) Information specifying the equip- and 0.1 ml sample portions, an equal volume ment, as approved under § 381.53, mate- of double strength lactose broth containng 1.2% Tergitol 7 is added. Then determined by rials, and conditions of use incident to procedure in Microbiology Laboratory the system. Items which must be so Guidebook, FSIS, USDA, January 1974, Sec- specified include filters; rate of flow; tion 4.0; and computed using standard MPN pressures and/or vacuums required for tables.

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(4)(i) In order to facilitate continuous and draining practices and procedures processing operations, poultry car- shall be such as will minimize moisture casses and major parts may be held absorption and retention at time of overnight in chilling tanks containing packaging. water-saturated ice, refrigerated water, (2) With respect to ready-to-cook or other approved cooling media that poultry that is to be frozen, cooked, or will maintain all poultry in the tanks consumer packaged, as whole poultry, at a temperature of 40 °F., or lower. the maximum moisture absorption and Practices (such as reicing, recircula- retention during washing, chilling, and tion of the chilling medium, or holding draining processes shall not exceed, at product in refrigerated rooms, or use of the last readily accessible point at increased amounts of ice) shall be em- which the poultry carcasses can be se- ployed that will result in all of the lected for testing prior to packaging, poultry in the chilling tanks being the percentage limits set forth in the maintained at a temperature of 40 °F. following tables. or lower throughout the holding period. TABLE 1ÐMAXIMUM MOISTURE ABSORPTION (ii) Poultry which is to be held in AND RETENTION LIMITS FOR ALL CLASSES OF chilling tanks in excess of 24 hours POULTRY, OTHER THAN TURKEYS, TO BE shall at the end of the 24-hour chilling CONSUMER PACKAGED, FROZEN OR COOKED period be removed from the tanks and AS WHOLE POULTRY repacked in clean ice and in clean Average percent in- tanks which are continually drained, crease in weight or as an alternative, the tanks shall be over weight of car- Average ready-to-cook carcass cass prior to final drained and reiced and placed in a cool- weight prior to final washer (less washer (less necks er which will maintain all of the poul- necks and giblets) and giblets) try in the tanks at a temperature at 40 Zone A 1 Zone B 1 °F. or below. (5) Giblets shall be chilled to 40 °F. or Chickens 41¤4 lbs. and under ...... 8.0 8.7 lower within 2 hours from the time Chickens over 41¤4 lbs. and all other classes of poultry other than tur- they are removed from the inedible keys ...... 6.0 6.7 viscera, except that when they are 1 Product shall be retained if, out of five consecutive tests cooled with the carcass, the require- more than one test exceeds the Zone A limits or any test ex- ments of paragraph (b)(2) of this sec- ceeds the Zone B limits. These zone limits were based on a statistical analysis of variation between individual birds with tion shall apply. Any of the acceptable regard to moisture absorption. With these limits the chance of methods of chilling the poultry carcass passing a lot with average moisture at or above the Zone A limit is less than 15 percent. A lot with average moisture at or may be followed in cooling giblets. above the Zone B limit would have virtually no chance of When continuous chillers are used to passing. chill giblets or necks, the fresh water intake in the chiller shall be not less TABLE 2ÐMAXIMUM MOISTURE ABSORPTION than 1 gallon per 40 frying chickens AND RETENTION LIMITS FOR ALL TURKEYS TO processed, and shall be proportionately BE CONSUMER PACKAGED, FROZEN OR increased for other classes of poultry. COOKED AS WHOLE POULTRY When necks are chilled together with Average percent in- giblets, the minimum fresh water increase in weight take shall be not less than 1 gallon per Average ready-to-cook carcass over weight of car- weight prior to final washer (less cass prior to final 20 frying chickens processed and shall necks and giblets) washer (less necks be proportionately increased for other and giblets) classes of poultry. The required mini- Zone A 1 Zone B 1 mum fresh water intake in giblet and neck chillers shall be measured 8 lbs. 8 ozs. and under ...... 8.0 9.0 8 lbs. 9 ozs.±15 lbs. 15 ozs ...... 6.0 6.4 through a meter which gives cumu- 16 lbs.±16 lbs. 15 ozs ...... 5.8 6.05 lative readings, and the meter shall be 17 lbs.±17 lbs. 15 ozs ...... 5.5 5.75 readily accessible. In continuous giblet 18 lbs.±18 lbs. 15 ozs ...... 5.3 5.55 or neck chillers, the temperature of the 19 lbs.±19 lbs. 15 ozs ...... 5.1 5.35 chilling medium shall not exceed 36 °F. 20 lbs.±20 lbs. 15 ozs ...... 4.9 5.15 21 lbs.±21 lbs. 15 ozs ...... 4.8 5.05 in the warmest part of the system. 22 lbs.±22 lbs. 15 ozs ...... 4.6 4.85 (d) Moisture absorption and retention 23 lbs.±23 lbs. 15 ozs ...... 4.5 4.75 limits. (1) Poultry washing, chilling, 24 lbs.±26 lbs. 15 ozs ...... 4.4 4.65

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TABLE 2ÐMAXIMUM MOISTURE ABSORPTION moisture absorption and retention AND RETENTION LIMITS FOR ALL TURKEYS TO shall not exceed (when placed on the BE CONSUMER PACKAGED, FROZEN OR cutup line) the percentage limits set COOKED AS WHOLE POULTRYÐContinued forth in the following table:

Average percent in- AVERAGE PERCENT INCREASE IN WEIGHT OVER crease in weight WEIGHT OF CARCASS PRIOR TO FINAL WASHER over weight of car- Average ready-to-cook carcass (LESS NECKS AND GIBLETS) weight prior to final washer (less cass prior to final washer (less necks Zone A—10.0 1 necks and giblets) and giblets) Zone B—11.0 1 Zone A 1 Zone B 1 (ii) With respect to ready-to-cook 27 lbs. and over ...... 4.3 4.55 chicken carcasses, averaging 41⁄4 1 Product shall be retained if, out of five consecutive tests pounds or less, which are chilled in more than one test exceeds the Zone A limits or any test ex- continuous chillers only, prior to being ceeds the Zone B limits. These zone limits were based on a statistical analysis of variation between individual birds with cut up, the percentage limits set forth regard to moisture absorption. With these limits the chance of in paragraph (d)(5) of this section shall passing a lot with average moisture at or above the Zone A limit is less than 15 percent. A lot with average moisture at or apply. above the Zone B limit would have virtually no chance of (5) With respect to ready-to-cook passing. poultry other than that under para- (3) With respect to ready-to-cook tur- graph (d) (3) or (4)(i) of this section key carcasses that are to be cut up, the that is to be ice packed, the maximum maximum amount of moisture absorp- amount of moisture absorption shall tion and retention shall not exceed (at not exceed, at the last readily acces- the time the first cut is made) the per- sible point at which the poultry car- centage limits set forth in the follow- casses can be selected for testing on ing table: the drip line, the percentage limits set forth in the following table: TABLE 3ÐMAXIMUM MOISTURE ABSORPTION AND RETENTION LIMITS FOR ALL CLASSES OF MAXIMUM MOISTURE ABSORPTION AND RETENTION LIMITS FOR ICE PACK POULTRY TURKEYS TO BE CUT UP AVERAGE PERCENT INCREASE IN WEIGHT OVER Average percent increase in weight WEIGHT OF CARCASS PRIOR TO FINAL WASHER over weight of car- (LESS NECKS AND GIBLETS) Average ready-to-cook carcass cass prior to final weight prior to final washer (less Zone A—12.0 1 necks and giblets) washer (less necks and giblets) Zone B—13.0 1 Zone A 1 Zone B 1 (6) With respect to all ice pack poul- 8 lbs. 8 ozs. and under ...... 9.0 10.0 try, the loss of moisture during holding 8 lbs. 9 ozs.±15 lbs. 15 ozs ...... 7.0 7.4 and transportation to the first destina- 16 lbs.±16 lbs. 15 ozs ...... 6.8 7.05 tion shall result in moisture retention 17 lbs.±17 lbs. 15 ozs ...... 6.5 6.75 that is within the limits, applicable to 18 lbs.±18 lbs. 15 ozs ...... 6.3 6.55 19 lbs.±19 lbs. 15 ozs ...... 6.1 6.35 the class of poultry involved, set forth 20 lbs.±20 lbs. 15 ozs ...... 5.9 6.15 in Zone A of Tables 1 and 2 in para- 21 lbs.±21 lbs. 15 ozs ...... 5.8 6.05 graph (d)(2) of this section. 22 lbs.±22 lbs. 15 ozs ...... 5.6 5.85 23 lbs.±23 lbs. 15 ozs ...... 5.5 5.75 (7) Ten-bird tests shall be conducted 24 lbs.±26 lbs. 15 ozs ...... 5.4 5.65 at least daily by inspectors to assure 27 lbs. and over ...... 5.3 5.55 compliance with the requirements of 1 Product shall be retained if, out of five consecutive tests paragraphs (d) (1) through (5) of this more than one test exceeds the Zone A limits or any test exceeds the Zone B limits. These zone limits were based on a statistical analysis of variation between individual birds with 1 Product shall be retained if, out of five regard to moisture absorption. With these limits the chance of consecutive tests, more than one test ex- passing a lot with average moisture at or above the Zone A limit is less than 15 percent. A lot with average moisture at or ceeds the Zone A limits or any test exceeds above the Zone B limit would have virtually no chance of the Zone B limits. These zone limits were passing. based on a statistical analysis of variation (4)(i) With respect to ready-to-cook between individual birds with regard to moisture absorption. With these limits the chicken carcasses, averaging 41⁄4 chance of passing a lot with average mois- pounds or less, that are chilled in con- ture at or above the Zone A limit is less than tinuous chillers and further aged or 15 percent. A lot with average moisture at or chilled in slush ice and water, prior to above the Zone B limit would have virtually being cut up, the maximum amount of no chance of passing.

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section, using procedures set forth in holes to permit the water to drain out. the Poultry Inspectors’ Handbook. The However, the Administrator, upon inspectors’ 10-bird test will be used to written request and under such condi- determine such compliance, except as tions as he may prescribe in specific additional 50-bird tests are required cases, may approve the shipment of under paragraph (d)(8) of this section. poultry in operational type containers, (8) Each official establishment may such as chill tanks or lugs, from one of- make adjustments in its washing, ficial establishment to another official chilling, and draining methods pro- establishment for further processing. vided it submits to the inspector at the (11)(i) Giblets shall be handled in a establishment, written notice of the manner that will prevent free water proposed adjustments before any from being included in the giblet pack- changes are made, and provided fur- age. If giblet wrapping material is to be ther, that the operator of the establish- used, the average weight of giblet ment, immediately after the change, wrapping material shall be not more selects, prepares, identifies, and than 30 pounds per standard ream (24′′ x weighs, in accordance with procedures 36′′—500 sheets) when tested in accord- set forth in the Poultry Inspectors’ ance with the Technical Association of Handbook, 2 individually a random the Pulp and Paper Industry sample of 50 ready-to-cook poultry car- (T.A.P.P.I.) Standard T–410, except casses prior to the final washer and that the weight of such material may again when they are removed from the exceed 30 pounds per standard ream if, drip line or other draining device im- after absorption, as allowed by para- mediately before packing. If the aver- graph (d)(11)(ii) of this section, the ma- age weight of the 50 poultry carcasses terial does not weigh more than the taken before the final washer and their total of a 30-pound standard ream plus average weight after immediate re- the allowable absorption increase. moval from the drip line or draining (ii) Test samples shall be conditioned device show that the product is in com- in accordance with T.A.P.P.I. Standard pliance with the Zone A moisture ab- T–402. The sample to be tested shall sorption limits, applicable to the class consist of 10 sheets representative of of poultry involved, set forth in this the shipment or lot, and individual section, the adjusted methods will be- sheets within the sample may vary come the established washing, chilling, within normal tolerance from the pre- and draining system for the establish- scribed maximum weight, but the aver- ment. If the results of the weighing of age of the sample (10 sheets) shall not the sample of 50 carcasses show that weigh in excess of 30 pounds per stand- the product exceeds the Zone A limits ard ream (24′′ x 36′′—500 sheets) except set forth in this section, the poultry as specified above. The moisture ab- will be retained in accordance with sorption shall not exceed 200 percent of procedures set forth in the Poultry In- the dry weight of the sample (as condi- spectors’ Handbook. Retained poultry tions in accordance with T.A.P.P.I. shall not be released from the estab- Standard T–402) and giblet wrappers lishment until they meet the applica- (uncreped) shall not exceed the follow- ble requirements of paragraph (d) (2), ing sizes or equivalents: Chickens and (3), (4), or (5) of this section. Ducks, 9′′ x 12′′, Turkeys, 12′′ x 14′′. (9) The establishment shall provide (e) Air chilling. In air chilling ready- scales, weights, identification devices, to-cook poultry, the internal tempera- and other supplies necessary to con- ture of the carcasses shall be reduced duct all moisture tests. to 40 °F. or less within 16 hours. (10) When poultry is ice packed in (f) Freezing. (1) Ready-to-cook poul- barrels or other containers, the barrels try which is to be or is labeled with de- and containers shall be covered and scriptive terms such as ‘‘fresh frozen,’’ shall have an adequate number of drain ‘‘quick frozen’’ or ‘‘frozen fresh’’ or any other term implying a rapid change 2 The Poultry Inspectors’ Handbook is from a fresh state to a frozen state available upon request from the Food Safety shall be placed into a freezer within 48 and Inspection Service of the U.S. Depart- hours after initial chilling in accord- ment of Agriculture, Washington, DC 20250. ance with paragraph (b) of this section.

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During this period, if such poultry is traditional inspection procedure for not immediately placed into a freezer the different young chicken slaughter after chilling and packaging, it shall be line configurations are specified in the held at 36 °F. or lower. following table. These maximum rates (2) Ready-to-cook poultry shall be shall not be exceeded. The inspector in frozen in a manner so as to bring the charge shall be responsible for reducing internal temperature of the birds at production line rates where in the in- the center of the package to 0 °F. or spector’s judgment the prescribed in- below within 72 hours from the time of spection procedure cannot be ade- entering the freezer. Such procedures quately performed within the time shall not apply to raw poultry product available, either because the birds are described in § 381.129(b)(6)(i) of this sub- not presented by the official establish- chapter. ment in such a manner that the car- (3) Upon written request, and under casses, including both internal and ex- such conditions as may be prescribed ternal surfaces and all organs, are by the Administrator, in specific cases, readily accessible for inspection, or be- ready-to-cook poultry which is to be cause the health conditions of a par- frozen immediately may be moved ticular flock dictate a need for a more from the official establishment prior to extended inspection procedure. The freezing: Provided, That the plant and standards in § 381.170(a) of this part freezer are so located and such nec- specify which classes of birds con- essary arrangements are made that the stitute young chickens. Section Inspection Service will have access to 381.76(b) specifies when either the tra- the freezing room and adequate oppor- ditional inspection procedure or the tunity to determine compliance with modified traditional inspection proce- the time and temperature require- dure can or must be used. ments specified in paragraph (f)(2) of this section. MAXIMUM PRODUCTION LINE RATESÐYOUNG (4) Warm packaged ready-to-cook CHICKENSÐTRADITIONAL INSPECTION PROCE- poultry which is to be chilled by imme- DURES diate entry into a freezer within the of- Number Birds ficial establishment shall within 2 per in- Line configuration1 of inspector hours from time of slaughter be placed spection stations per in a plate freezer or a freezer with a minute functioning circulating air system 6±1 ...... 1 25 where a temperature of ¥10 °F. or 12±1 ...... 2 23 lower is maintained. 12±2 ...... 2 21 18±1 ...... 3 19 (5) Frozen poultry shall be held under 18±2 ...... 3 19 conditions which will maintain the 18±3 ...... 3 18 product in a solidly frozen state with 24±1 ...... 4 161¤2 temperature maintained as constant as 24±2 ...... 4 16 24±4 ...... 4 151¤2 possible under good commercial prac- 1 Birds are suspended on the slaughter line at 6– tice. inch intervals. The first number indicates the inter- (6) Immersion or spray freezing val in inches between the birds that each inspector examines. The second number indicates how many equipment shall be constructed of non- of the birds presented, the inspector is to inspect, corrosive metal or other acceptable i.e., ‘‘1’’ means inspect every bird. ‘‘4’’ means inspect every fourth bird, etc. material. Compounds used in immersion or spray freezing procedures shall [47 FR 23435, May 28, 1982] be approved by the Administrator. § 381.68 Maximum inspection rates— [37 FR 9706, May 16, 1972, as amended at 39 New turkey inspection system. FR 4568, 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412, (a) The maximum inspection rates Aug. 25, 1995] for one inspector New Turkey Inspec- tion (NTI–1) and two inspector New § 381.67 Young chicken slaughter in- Turkey Inspection (NTI–2) are listed in spection rate maximums under tra- the table below. These line speeds are ditional inspection procedure. for lines using standard 9-inch shackles The maximum birds to be inspected on 12-inch centers with birds hung on by each inspector per minute under the every shackle and opened with J-type

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or Bar-type opening cuts. Maximum less than 16 pounds. Heavy turkeys are rates for those establishments having all turkeys weighing 16 pounds or varying configurations will be estab- more. The weights refer to the bird at lished by the Administrator but will the point of post-mortem inspection, not exceed those in the table. Neither with blood, feathers and feet removed. the rates in the table nor those estab- (c) The inspector in charge may re- lished for establishments with varying duce inspection line rates when in his/ configurations shall be exceeded under her judgment the prescribed inspection any circumstances. procedure cannot be adequately per- (b) There are two categories of tur- formed within the time available be- keys for determining inspection rates, cause the health conditions of a par- ‘‘light turkeys’’ and ‘‘heavy turkeys’’. ticular flock dictate a need for a more Light turkeys are all turkeys weighing extended inspection.

MAXIMUM TURKEY INSPECTION RATES

Birds/Minute Line configu- Number of J-Type Bar-Type Inspection system ration inspectors 1 1 <16 (>16#) < (>16#) ) ( #) light heavy ( #) light heavy

NTI±1 ...... 12±1 1 32 30 25 21 NTI±2 ...... 2 24±2 2 51 41 45 35 1 This weight refers to the bird at the point of post-mortem inspection, without blood, feathers, or feet. 2 The turkeys are suspended on the slaughter line at 12-inch intervals, with two inspectors each looking at alternating birds at 24-inch intervals. [50 FR 37512, Sept. 16, 1985]

Subpart J—Ante Mortem spection Service, be disposed of as pro- Inspection vided in § 381.95.

§ 381.70 Ante mortem inspection; when § 381.72 Segregation of suspects on required; extent. ante mortem inspection. An ante mortem inspection of poul- All birds which on ante mortem in- try shall, where and to the extent con- spection do not plainly show, but are sidered necessary by the Administrator suspected of being affected with any disease or condition that under §§ 381.80 and under such instructions as he may to 381.93, inclusive, may cause con- issue from time to time, be made of demnation in whole or in part on post poultry on the day of slaughter in any mortem inspection, shall be segregated official establishment. from the other poultry and held for § 381.71 Condemnation on ante separate slaughter, evisceration, and mortem inspection. post mortem inspection. The inspector shall be notified when such segregated Birds plainly showing on ante lots are presented for post mortem in- mortem inspection any disease or con- spection and inspection of such birds dition, that under §§ 381.80 to 381.93, in- shall be conducted separately. Such clusive, would cause condemnation of procedure for the correlation of ante their carcasses on post mortem inspec- mortem and post mortem findings by tion, shall be condemned. Birds which the inspector, as may be prescribed or on ante mortem inspection are con- approved by the Administrator, shall demned shall not be dressed, nor shall be carried out. they be conveyed into any department of the official establishment where § 381.73 Quarantine of diseased poul- poultry products are prepared or held. try. Poultry which has been condemned on If live poultry, which is affected by ante mortem inspection and has been any contagious disease which is trans- killed or died otherwise shall under the missible to man, is brought into an of- supervision of an inspector of the In- ficial establishment, such poultry shall

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be segregated. The slaughtering of such antimicrobial residues in any species of poultry shall be deferred and the poul- poultry. try shall be dealt with in one of the fol- [47 FR 41336, Sept. 20, 1982] lowing ways: (a) If it is determined by a veterinary § 381.75 Poultry used for research. inspector that further handling of the (a) No poultry used in any research poultry will not create a health hazard, investigation involving an experi- the lot shall be slaughtered separately, mental biological product, drug, or subject to ante mortem and post chemical shall be eligible for slaughter mortem inspection pursuant to the reg- at an official establishment unless the ulations. operator of such establishment, the (b) If it is determined by a veterinary sponsor of the investigation, or the in- inspector that further handling of the vestigator has submitted to the Inspec- poultry will create a health hazard, tion Service, or the Veterinary Bio- such poultry may be released for treat- logics unit of Veterinary Services, Ani- ment under the control of an appro- mal and Plant Health Inspection Serv- priate State or Federal agency. If the ice of the Department or the Environ- circumstances are such that release for mental Protection Agency, or the Food treatment is impracticable, a careful and Drug Administration of the De- bird-by-bird ante mortem inspection partment of Health, Education, and shall be made, and all birds found to Welfare, data or a summary evaluation be, or which are suspected of being, af- of the data which demonstrates that fected with a contagious disease trans- the use of such biological product, missible to man shall be condemned. drug, or chemical will not result in the products of such poultry being adulter- § 381.74 Poultry suspected of having ated, and the Administrator has ap- biological residues. proved such slaughter. When any poultry at an official es- [37 FR 9706, May 16, 1972, as amended at 39 tablishment is suspected of having FR 4569, Feb. 5, 1974] been treated with or exposed to any substance that may impart a biological residue that would make their edible Subpart K—Post Mortem Inspec- tissues adulterated, they shall, at the tion; Disposition of Carcasses option of the operator of the establish- and Parts ment, be processed at the establishment and the carcasses and all parts § 381.76 Post-mortem inspection, when required; extent; traditional, thereof retained under U.S. Retained Streamlined Inspection System tags, pending final disposition in ac- (SIS), New Line Speed (NELS) In- cordance with § 381.80, of this part, and spection System and the New Tur- other provisions in subpart K; or they key Inspection (NTI) System; rate of shall be slaughtered at the establish- inspection. ment and buried or incinerated in a (a) A post-mortem inspection shall be manner satisfactory to the inspector. made on a bird-by-bird basis on all Alternatively, such poultry may be re- poultry eviscerated in an official estab- turned to the grower, if further holding lishment. No viscera or any part there- is likely to result in their not being of shall be removed from any poultry adulterated by reason of any residue. processed in any official establishment, The Inspection Service will notify the except at the time of post-mortem in- other Federal and State agencies con- spection, unless their identify with the cerned of such action. To aid in deter- rest of the carcass is maintained in a mining the amount of residue present manner satisfactory to the inspector in the poultry, officials of the Inspec- until such inspection is made. Each tion Service may permit the slaughter carcass to be eviscerated shall be of any such poultry for the purpose of opened so as to expose the organs and collecting tissues for analysis of the the body cavity for proper examination residue. Such analysis may include the by the inspector and shall be prepared use of inplant screening procedures de- immediately after inspection as ready- signed to detect the presence of to-cook poultry. If a carcass is frozen,

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it shall be thoroughly thawed before (3) The following requirements are being opened for examination by the applicable to SIS: inspector. Each carcass, or all parts (i) Definitions. For purposes of this comprising such carcass, shall be ex- paragraph, the following definitions amined by the inspector, except for shall apply: parts that are not needed for inspec- (a) Cumulative sum (CUSUM). A station purposes and are not intended for tistical concept used by the establish- human food and are condemned. ment and monitored by the inspector (b)(1) There are four systems of post- whereby compliance is determined mortem inspection: Streamlined In- based on sample results collected over spection System (SIS) and the New a period of time. For purposes of deter- Line Speed (NELS) Inspection System, mining compliance with the finished both of which shall be used only for product standards, the CUSUM is equal broilers and cornish game hens; the to the sum of prior test results plus the New Turkey Inspection (NTI) System, weighted result of the current test which shall be used only for turkeys; minus the tolerance, with the condi- and Traditional Inspection. tion that the resulting CUSUM cannot (i) The SIS shall be used only for go below zero. broilers and cornish game hens if: (b) Tolerance number. A weighted (a) The Administrator determines measure that equates to product being that SIS will increase inspector effi- produced at a national product quality ciency; or level. See Table 2. (b) The operator requests SIS and the (c) Action number. A level reached by Administrator determines that the sys- the CUSUM where the process is out of tem will result in no loss of inspection control and product action is required efficiency. by the establishment or the inspector. (ii) The NELS Inspection System See Table 2. shall be used only for broilers and cor- (d) ‘‘Start number’’. A value halfway nish game hens if: between zero and the action number. The start number is used to determine (a) The operator requests the NELS the starting CUSUM for the first sub- Inspection System, and group of a shift and to reset the (b) The Administrator determines CUSUM value if the CUSUM is equal to that the establishment has the intent or greater than the action number. See and capability to operate at line speeds Table 2. greater than 70 birds per minute, and (e) Subgroup. A 10-bird sample col- meets all the facility requirements in lected before product enters the chiller § 381.36(d) and receives approval of its and after product leaves the chiller. partial quality control program as (f) Subgroup absolute limit. The toler- specified in paragraph (c) of this sec- ance number plus 5. See Table 2. tion. (g) Prechill testing. Testing conducted (iii) The NTI System shall be used by the establishment to determine the only for turkeys if: CUSUM on consecutive 10-bird sub- (a) The operator requests it, and group samples collected prior to prod- (b) The Administrator determines uct entering the chilling system. that the establishment meets all the (h) Postchill testing. Testing con- facility requirements in § 381.36(e), and ducted by the establishment to deter- receives approval of its partial quality mine the CUSUM on consecutive 10- control program as specified in para- bird subgroup samples collected as the graph (c) of this section. product leaves the chilling system. (iv) Traditional inspection shall be (i) Rework. Reprocessing the product used for turkeys when the NTI System to correct the condition or conditions is not used. For other classes of poul- causing the nonconformances listed in try, Traditional Inspection shall be Table 1. used when neither the SIS nor the (ii) General. (a) Under SIS, one in- NELS Inspection System is used. spector inspects the outside, inside, (2) The requirements of paragraph (a) and viscera of each bird. There may be of this section are applicable to all four two inspectors on one processing line, inspection systems. each inspecting every other bird. For

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the establishment to run its processing addressed elsewhere in this subpart) line(s) at maximum speed, optimal con- under each. ditions must be maintained so that in- (iii) Post-mortem inspection. (a) Facili- spection may be conducted efficiently. ties: Each inspection station must The inspector in charge determines the comply with the facility requirements speed at which each processing line in § 381.36(c). may be operated to permit inspection. (b) Presentation: Each inspector shall A variety of conditions may affect this be flanked by an establishment em- determination including the health of ployee assigned to be the inspector’s each flock and the manner in which helper. The one inspector on the SIS–1 birds are being presented to the inspec- line shall be presented every bird. Each tor for inspection. inspector on the SIS–2 line shall be pre- (b) SIS may be performed by one in- sented every other bird on the line. An spector (SIS–1) or two inspectors (SIS– establishment employee shall present 2). SIS–1 requires that the establish- each bird to the inspector properly ment provide one inspection station for eviscerated with the back side toward each line and adequate reinspection fa- the inspector and the viscera uniformly cilities so carcasses can be removed trailing or leading. Each inspector from each line for evaluation. The shall inspect the inside, viscera, and maximum line speed for SIS–1 is 35 outside of all birds presented. birds per minute. SIS–2 requires that (c) Disposition: The inspector shall the establishment provide two inspec- determine which birds shall be tion stations for each line and ade- salvaged, reprocessed, condemned, re- quate reinspection facilities so car- tained for disposition by the veterinar- casses can be removed from each line ian, or allowed to proceed down the for evaluation. The maximum line line as a passed bird subject to trim speed for SIS–2 is 70 birds per minute. and reinspection. Carcasses with cer- (c) Under all inspection systems, in- tain defects not requiring condemna- cluding SIS, inspectors conduct post- tion of the entire carcass shall be mortem inspection and look for a num- passed by the inspector, but shall be ber of conditions, as specified else- subject to reinspection to ensure the where in this subpart, which may indi- physical removal of the defects. The cate adulteration. Adulterated product helper, under the supervision of the in- is condemned and destroyed, except spector, shall mark such carcasses for that carcasses and parts which may be trim when the defects are not readily made unadulterated by reprocessing observable. Trimming of birds passed (reworking) may be so reprocessed subject to reinspection shall be per- under the supervision of an inspector formed by: and reinspected. Under SIS, inspectors (1) The helper, time permitting, and also reinspect product by sampling fin- (2) One or more plant trimmers posi- ished birds (both before and after tioned after all giblets are harvested chilling) for nonconformances with fin- and prior to reinspection. ished product standards (see Table 1). If (iv) Reinspection. (a) Facilities: Rein- such nonconformances are present at spection stations are required at both certain statistical levels, it may indi- the prechill and postchill locations. cate process difficulties requiring cor- The Agency will determine the number rective action by the establishment. If of stations needed in those establish- the establishment does not take ade- ments having more than one processing quate corrective action, the inspector line or more than one chiller. One or shall initiate corrective actions such as more prechill reinspection stations conducting closer post-mortem inspec- shall be conveniently located at the tions and requiring reprocessing and end of the line or lines prior to reinspection of previously processed chilling. One or more postchill stations carcasses and parts. Thus, SIS is con- must be conveniently located at the ducted in two phases—a post-mortem end of the chiller or chillers. The inspection phase and a reinspection prechill and postchill reinspection sta- phase. The following paragraphs de- tions must meet the following provi- scribe the inspection requirements (not sions:

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(1) Floor space shall consist of 3 feet itor the production through the chill along each conveyor line. The space system to ensure that it meets the shall be level and protected from all postchill FPS. This test is independent traffic and overhead obstructions. of the prechill test. Compliance is (2) A table at least 2 feet wide and 2 measured by determining the CUSUM feet deep and 3 feet in height designed on consecutive 10-bird subgroup sam- to be readily cleanable and drainable ples as they exit the chilling system. shall be provided for reinspecting the When the system is operating within sampled birds. compliance, the establishment applies (3) A minimum of 200 foot-candles of the FPS to product samples at the shadow-free lighting with a minimum prechill reinspection station. Testing color rendering index of 85 on the table time and time between tests are such surface. that birds represented by the test are (4) A separate clip board holder shall still within the chiller. If an out-of- be provided for holding the recording compliance condition is found, the sheets. product leaving the chiller is seg- (5) Hangback racks designed to hold regated for rework and retested before 10 carcasses shall be provided for and it may proceed into commerce. A sec- positioned within easy reach of the per- ond 10 bird subgroup sample of the son at the station. birds is taken after they leave the (b) Disposition: An inspector shall chiller to ensure that the product monitor the establishment’s applica- meets the postchill FPS. Since the tion of the Finished Product Standards product is closer to the end of process- program and shall take corrective ac- ing, the controls on releasing reworked tion including retaining product to pre- product are stricter than controls vent adulterated product from leaving under prechill testing, again to ensure the establishment when the inspector that no adulterated product enters into determines that the establishment has commerce. failed to apply the program as pre- (d) Prechill testing. The prechill FPS scribed in paragraph (b)(3)(iv)(c) of this have been divided into processing and section). trim categories. The processing cat- (c) Finished Product Standards: Fin- egory is designed to monitor the out- ished Product Standards (FPS) are cri- put of the dressing and evisceration teria applied to processed birds before procedures. The trim category mon- and after chill to ensure that the prod- itors the establishment’s ability to re- uct being produced is consistently move unwholesome lesions and condi- wholesome and unadulterated. These tions from inspected and passed car- criteria consist of nonconformances casses. Each category is monitored (listed in Table 1), the incidence of independently of the other category which is determined from 10 bird sub- using a separate CUSUM for each cat- group samples, reduced to a CUSUM egory. number, and measured against the (1) Actions to be taken when the process standards (Table 2). The standards are is in control. If the CUSUM is less than applied to permit the Agency to esti- the action number and the subgroup mate when the production process is in absolute limit is not exceeded, the control and when it is out of control. process is judged to be in control. The establishment is responsible for (i) Establishment Actions. The estab- maintaining FPS which, in turn, is lishment shall: monitored by the inspector. FPS is ap- (A) Randomly select and record sub- plied in two separate parts. The first is group sampling times for each produc- called prechill testing. It is designed to tion unit of time before product ensure that the slaughter and eviscera- reaches the prechill reinspection station procedures are in control. Compli- tion on the production line. In no case ance is measured by determining the shall the time between tests exceed 1 CUSUM on consecutive 10-bird sub- hour of production time. group samples collected prior to prod- (B) Conduct a 10-bird subgroup test uct entering the chilling system. The at a random time on each poultry second part of the FPS is called slaughter line. These times are postchill testing. It is designed to mon- preselected by the establishment and

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available to the inspector prior to the actions as set forth in paragraph start of the shift/day’s operations. All (b)(3)(iv)(d)(4) of this section. 10 samples of the subgroup shall be col- (3) Actions to be taken when a lected at the random time. trimmable lesion/condition is found. If ei- (C) Obtain the weighted value of each ther inspection or plant monitoring nonconformance by multiplying the finds any trimmable lesion or condi- number recorded for each nonconform- tion as specified in item B(7) of Table 1 ance by the ‘‘factor’’ in Table 1, sum during a prechill subgroup test, the es- the total of all the nonconformances, tablishment shall immediately conduct and calculate the CUSUM value for an additional prechill subgroup test for that test. the same trimmable lesion/condition (ii) Inspector Actions. The inspector category. This is a requirement on the shall: subgroup testing for the prechill trim (A) Select random times for monitor- nonconformance that is in addition to ing subgroup tests for each half-shift the CUSUM test described in paragraph on the evisceration line. In establish- (b)(3)(iv)(d)(1) of this section. ments that have multiple evisceration (i) If no additional item in the same lines on a production shift, monitor all category is found on retest, the estab- lines of product at the random times. lishment shall resume random time sampling. (B) Collect the subgroup samples to (ii) If an additional item in the same be monitored at preselected times. All category is found on retest, the estab- 10 samples of the subgroup shall be col- lishment shall proceed as if CUSUM lected at the random time selected in reaches the action number and shall paragraph (b)(3)(iv)(d)(1)(ii)(A) of this initiate corrective action set forth in section. paragraph (b)(3)(iv)(d)(4) of this section (C) Conduct the 10-bird monitoring for this category only. subgroup test. (4) Actions to be taken when the (2) Actions to be taken when the sub- CUSUM reaches the action number. Once group absolute limit is exceeded. If either CUSUM reaches the action number, the an inspector or establishment subgroup process is judged to be not in control. test exceeds the subgroup absolute (i) Establishment Actions. The estab- limit of tolerance plus 5 (T+5), the es- lishment shall: tablishment shall determine if any of (A) Immediately notify the inspector the immediate past 5 plant prechill in charge and the production super- subgroups for that category (processing visor responsible for the affected evis- or trim) resulted in a CUSUM above ceration line. the start number. (B) Suspend random time prechill (i) If all of the past 5 plant prechill testing of the affected nonconformance subgroups are at or below the start category (processing or trim). Suspend number, the establishment shall imme- random time postchill subgroup testing diately conduct a retest subgroup on when the processing category is the af- that category of prechill to determine fected nonconformance category. sample validity. If retest subgroup (C) Conduct subgroup retests on car- total equals tolerance or less, the es- casses leaving the chill system. Apply tablishment resumes random time test- the prechill criteria in Table 1 (A) or ing. If the retest subgroup total ex- (B), depending upon which category ceeds tolerance, the establishment caused the action, and apply prechill shall proceed as if CUSUM reaches the Finished Product Standards as listed in action number and shall begin process Table 2 to determine product compli- actions as set forth in paragraph ance. In no case shall the time between (b)(3)(iv)(d)(4) of this section. In either retests exceed 30 minutes of production case, the prechill retest results will be time. Apply prechill standard criteria used to calculate CUSUM. at the postchill location after notifying (ii) If any of the past 5 plant prechill the establishment’s production super- subgroups resulted in a CUSUM above visor. If any of these subgroup retests the start number, the establishment on product leaving the chill system re- shall proceed as if CUSUM reaches the sult in a subgroup total exceeding tol- action number and shall begin process erance, identify for rework subsequent

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product at the postchill location. All against the postchill criteria. The sub- noncomplying product will be brought group nonconformance weights shall be into compliance prior to release into totaled and the CUSUM calculated by commerce. Product from the chiller subtracting the tolerance from the sum will continue accumulating for rework of the subgroup total and the starting until a subsequent subgroup test re- CUSUM. sults in a subgroup total equal to or (1) Actions to be taken when the process less than tolerance. is in control. If the CUSUM is less than (D) Conduct additional subgroup the action number and the subgroup tests at the prechill reinspection sta- absolute limit is not exceeded, the tion to determine the adequacy of pro- process is judged to be in control. duction corrective action. If the (i) Establishment Actions. The estab- prechill tests results in a subgroup lishment shall conduct a 10-bird sub- total exceeding the tolerance, notify group test for each chiller system at a the production supervisor. The number randomly selected time of production. of additional tests at the postchill rein- In no case shall the time between tests spection station using prechill stand- exceed 2 hours of production time. ards is increased as required to include (ii) Inspector Actions. The inspector the product in the chiller represented shall: by this additional prechill test. (A) Select random times for postchill (E) After two consecutive additional monitoring. prechill subgroup tests result in sub- (B) Monitor each chill system twice group totals equal to or less than toler- per shift. ance: — Resume random time prechill sub- (C) Conduct subgroup tests at group testing as set forth in actions to preselected random times. be taken when the process is in control (2) Actions to be taken when the sub- at paragraph (b)(3)(iv)(d)(1) of this sec- group absolute limit is exceeded. If either tion. an inspector or establishment subgroup — Identify product entering the chill test exceeds the subgroup absolute system that will mark the end of the limit of tolerance plus 5(T+5), the es- retest action upon arrival at the tablishment shall determine if any of postchill sampling location. Such iden- the last 5 postchill monitoring sub- tification may include tagging or groups resulted in a CUSUM above the empty space in chillers, depending start number. upon the establishment’s identification (i) If all of the past 5 postchill mon- method. itoring subgroups resulted in a CUSUM — Once all product identified as at or below the start number, the es- needing retesting has arrived at the tablishment shall immediately retest a postchill sampling location, random subgroup to determine sample validity. time postchill FPS testing resumes. If this retest subgroup total exceeds — If two consecutive additional tolerance, the establishment shall pro- prechill subgroup tests demonstrate ceed as if CUSUM reaches the action process control with subgroup totals number and shall begin process actions equal to or less than tolerance, but as set forth in paragraph (b)(3)(iv)(e)(3) they do not cause CUSUM to fall to the of this section. start line or below, reset CUSUM at (ii) If any of the past 5 postchill mon- the start number. itoring subgroups resulted in a CUSUM (ii) Inspector Actions. The inspector above the start number, the establish- shall monitor product and process ac- ment shall proceed as if CUSUM tions by making spot-check observa- reaches the action number and shall tions to ensure that all program re- begin process actions as set forth in quirements are met. paragraph (b)(3)(iv)(e)(3) of this section. (e) Postchill testing. Postchill sub- (3) Actions to be taken when the groups shall be collected after the CUSUM reaches the action number. Once product leaves the chiller but before CUSUM reaches the action number, the the product is divided into separate process is judged to be not in control. processes. Each bird sampled shall be (i) Establishment Actions. The estab- observed and its conformance measured lishment shall:

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(A) Notify the inspector in charge (a) Offline product. The establish- and the production supervisor respon- ment shall identify the affected prod- sible for product in the chiller. uct so that it may be segregated and (B) Suspend random time postchill accumulated offline for rework. The in- subgroup testing. spector shall spot check the establish- (C) Immediately conduct an addi- ment’s identification, segregation, and tional postchill subgroup test. If the control of reworked product to ensure retest subgroup total exceeds toler- that program requirements are met. ance, the establishment shall identify (b) Reworked product. Reworked subsequent product for rework. Prod- product must be tested by the estab- uct will continue accumulating for re- lishment with a randomly selected sub- work until a subsequent subgroup test group test of the accumulated re- results in a subgroup total equal to or worked lot. Before product is released, less than tolerance. the random subgroup test must result (D) After two consecutive additional in a subgroup total equal to or less postchill subgroup tests results in sub- than tolerance. If the subgroup test of group totals equal to or less than toler- a reworked lot results in a subgroup ance: total exceeding tolerance, the lot must — Resume random time postchill be reworked again before another sub- subgroup testing as set forth in actions group is selected. The following actions to be taken when the process is in con- are required. trol at paragraph (b)(3)(iv)(e)(1) of this (1) Establishment Actions. The estab- section. lishment shall: — If the two consecutive additional (i) Select the random subgroup from postchill subgroup totals equal to or throughout the lot only after the total less than tolerance do not cause lot has been reworked. CUSUM to fall to the start number or (ii) Conduct the subgroup test using below, reset CUSUM at the start num- the same criteria (prechill or postchill) ber. that resulted in the rework action. (ii) Inspector Actions. The inspector (iii) Release the lot if the reworked shall monitor product and process ac- subgroup test resulted in a subgroup tions to ensure that program require- total equal to or less than tolerance. ments are met. (iv) Identify and control the lot to be (v) When the prechill or postchill reworked if the reworked subgroup product has been identified as having total again exceeds tolerance. been produced when the process was (2) Inspector Actions: The inspector not in control, additional online sub- shall spot check the rework procedure group testing by the establishment is to ensure that plant monitoring and required to determine its conformance production meet the requirements of to the standard. If any of the addi- the program. tional plant subgroup testing results in (vi) After the 10 bird subgroup tests a subgroup total exceeding tolerance, are completed, the prechill and offline product corrective actions must postchill processing nonconformances take place. The responsibilities of the shall be corrected on all bird samples establishment and the inspector prior to returning the samples to the change depending on the CUSUM. product flow. Samples with trim All corrective actions such as identi- nonconformances shall be returned to fying affected product, segregating the trim station for correction prior to product, and maintaining control their return to the product flow. through rework actions are the establishment’s responsibility. Corrective TABLE 1—DEFINITIONS OF actions by the inspector depends upon NONCONFORMANCES the establishment’s ability to control A Processing Nonconformances rework of affected product. If the es- 1 Extraneous material ≤1⁄16″ tablishment fails in its responsibilities, —Include any specks, tiny the inspector will identify, segregate, smears, or stains of material that measure 1⁄16″ or and retain affected product to prevent less in the greatest dimen- adulterated product from reaching con- sion. sumers.

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TABLE 1—DEFINITIONS OF TABLE 1—DEFINITIONS OF NONCONFORMANCESÐContinued NONCONFORMANCESÐContinued Examples: Ingesta, feces, —A maximum of two inci- unattached feathers, dents per carcass. grease, bile remnants, 8 Feces ≥1⁄8″ and/or whole gall bladder —Any material determined or spleen, embryonic to be from the lower gas- yolk, etc. trointestinal tract, measur- —Factor is one. ing 1⁄8″ or more, equals one —1 to 5=1 defect: 6 to 10=2 de- incident. fects; 11 or more=3 defects. —Factor is five. A maximum of three inci- —A maximum of one incident dents per carcass. per carcass. 2 Extraneous material >1⁄16″ to 9 Intestine 1″ —Any identifiable portion of —The same material as line the terminal portion of the 1, but measuring >1⁄16″ to 1″ intestinal tract with a in the longest dimension. lumen (closed circle) —Factor is one. present, or split piece of in- —A maximum of three inci- testine large enough to be dents per carcass. closed to form a lumen. Note: Feces that is 1⁄8″ or —Factor is five. greater should be classi- —A maximum of one incident fied under number 8 per carcass. Feces. 10 Cloaca 3 Extraneous material >1″ —Any identifiable portion of —The same material as lines the terminal portion of the 1 to 2, but measuring great- intestinal tract with er than one inch. mucosal lining. —Factor is two. —Factor is five. —A maximum of two inci- —A maximum of one incident dents per carcass. per carcass. 4 Oil glands remnant—less than 11 Bursa of Fabricius two whole glands —A whole rosebud, or identi- —Recognizable fragment(s) of fiable portion with two or one or both oil glands more mucosal folds. equals one incident. —Factor is two. —Factor is one. —A maximum of one incident —Maximum of one incident per carcass. per carcass. 12 Esophagus 5 Oil glands—two whole glands —Any portion of the esopha- —Both whole oil glands with gus with identifiable no missing fragments mocosal lining. equals one incident. If the —Factor is two. oil glands are cut, but no —A maximum of one incident fragment is removed, con- per carcass. sider them to be whole. But 13 Crop—partial—with mucosa if even a small fragment is —Any portion of the crop removed, use line 4. that includes the mucosal —Factor is two. lining. —A maximum of one incident —Factor is two. per carcass. —A maximum of one incident 6 Lung ≥1⁄4″ whole per carcass. —Any portion less than a 14 Crop—whole whole lung, and equal to or —Any complete crop. greater than 1⁄4″ at the —Factor is five. greatest dimension, equals —A maximum of one incident one incident. per carcass. —Factor is one. 15 Trachea ≤1″ —A maximum of two inci- —Identifiable portion of tra- dents per carcass. chea less than or equal to 7 Lung—whole one inch long. —Each whole lung equals one —Factor is one. incident. —A maximum of one incident —Factor is two. per carcass.

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TABLE 1—DEFINITIONS OF TABLE 1—DEFINITIONS OF NONCONFORMANCESÐContinued NONCONFORMANCESÐContinued 16 Trachea >1″ —Factor is two. —Identifiable portion of tra- —A maximum of one incident chea greater than one inch. per carcass. —Factor is two. 3 Bruise 1⁄2″ to 1″ —A maximum of one incident —Blood clumps or clots in per carcass. the superficial layers of tis- 17 Hair ≥1⁄4″ 26 or more. sue, skin, muscle or loose —Hair which is one-fourth subcutaneous tissue may be inch long or longer meas- slit and the blood com- ured from the top of the pletely washed out. When follicle to the end of the the bruise extends into the hair. 26 or more hairs equal deeper layers of muscle, the one incident. affected tissue must be re- —Factor is one. moved. Very small bruises —A maximum of one incident less than 1⁄2″ (dime size) and per carcass. areas showing only slight 18 Feather and/or Pinfeathers reddening need not be ≤1″ —Attached feathers or pro- counted as defects. truding pinfeathers less —Factor is one. than or equal to one inch —A maximum of five inci- long. Scored 5 to 10 per car- dents per carcass. cass as one incident, 11 to 4 Bruise >1″ 15 per carcass as two inci- —Same criteria as in line dents, and 16 or more as three, but greater than one three incidents. inch in greatest dimension. —Factor is one. —Factor is two. —A maximum of three inci- —A maximum of three incidents per carcass. dents per carcass. 19 Feathers >1″ 5 Bruise black/green 1⁄4″ to 1″ —Attached feathers longer —Bruises 1⁄4″ to 1″ that have than one inch. Scored 1 to 3 changed from red to a per carcass as one incident black/blue or green color 4 to 6 per carcass as two in- due to age. cidents, and 7 or more as —Factor is two. three incidents. —Factor is one. —A maximum of three inci- —A maximum of three incidents per carcass. dents per carcass. 6 Bruise Black/green >1″ 20 Long Shank—both condyles —Same as line 5, but measur- covered ing greater that 1″ in great- —If the complete tibiotarsal est dimension. joint is covered, it equals —Factor is five. one incident. —A maximum of two inci- —Factor is two. dents per carcass. —A maximum of two inci- 7 Trimmable lesions/Condition dents per carcass. —A trimmable tumor or B Trim nonconformances identifiable portion of a 1 Breast blister tumor on any part of the —Inflammatory tissue, fluid, carcass. or pus between the skin and —Trimmable Synovitis/ keel must be trimmed if airsacculitis (saddle/frog) membrane ‘‘slips’’ or if lesions that have not been firm nodule is greater than removed. 1⁄2″ in diameter (dime size). —Lesion/condition subject to —Factor is two. —A maximum of one incident removal following an ap- per carcass. proved cleanout process. 2 Breast blister—partially Examples: airsacculitis, trimmed salpingitis, nephritis, —All inflammatory tissue, spleen, or liver conditions including that which ad- requiring removal of the heres tightly to the keel kidneys. bone, must be removed.

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TABLE 1—DEFINITIONS OF TABLE 1—DEFINITIONS OF NONCONFORMANCESÐContinued NONCONFORMANCESÐContinued Note: All establishments shall Note: Bruises not associ- develop and maintain a perma- ated with the fracture nent marking system that should be recorded in the identifies carcasses with re- appropriate lines. movable lesions/conditions on —Factor is one. the inside surfaces. When re- —A maximum of two inci- movable lesions/conditions are dents per carcass. identified inside the carcass by 11 Untrimmed short hock the inspector, the helper will —When no cartilage of the be notified to apply the perma- hock surface is present and nent mark. When removable in- no tendons are attached to side lesions/conditions are the bone. found on a subgroup sample —Factor is two. without the permanent mark, —A maximum of two inci- the error is not recorded in line dents per carcass. 7. The affected carcass(s) will 12 Sores, scabs, inflammatory be hungback for IIC disposition process, etc. ≤1⁄2″ and corrective action. —Any defects such as sores, —Factor is five. abscesses, scabs, wounds, dermatitis, inflammatory —A maximum of one incident process, that measure less per carcass. than or equal to 1⁄2″ in the 8 Failure to complete task as greatest dimension. indicated by marking system. —Factor is two. Example: Synovitis, —A maximum of two inci- airsacculitis, inflammatory dents per carcass. process, contamination, 13 Sores, scabs, inflammatory etc. process, etc. >1⁄2″ —The helper, under the in- —Same as line 12, but great- spector’s direction, will est dimension is greater apply a mark to the car- than 1⁄2″, or a cluster of cass, indicating to the smaller lesions in close trimmer(s) that specific ac- proximity >1⁄2″, this cat- tion must be taken on that egory also includes turkey carcass. When airsac and leg edema. kidney cleanout, or syno- —Factor is five. vitis part removal, or car- —A maximum of one incident cass removal from the line per carcass. is not completed, or only 14 External mutilation partially completed, this —Mutilation to the skin and/ occurrence is recorded as or muscle that is caused by one defect. the slaughter, dressing or —Factor is five. It will also eviscerating processes. be recorded as a line 7 de- Skinned elbows (bucked fect for a total factor of 10. wings) do not trim require —A maximum of one incident unless affected wing joint per carcass. capsule is also opened. 9 Compound fracture —Factor is one. —Any bone fracture (i.e., leg —A maximum of three inci- or wing) that has caused an dents per carcass. opening through the skin. C Postchill nonconformances— May be accompanied with a (Designed to monitor those bruise, but not always. Do nonconformances added to not count the bruise in line product during the chilling 3 or 4 if it is associated process) ≤1 ″ with the compound frac- 1 Extraneous material ⁄16 ture. —Include specks, grease, or unidentifiable foreign ma- —Factor is two. terial that measure 1⁄16″ or —A maximum of three inci- less in the greatest dimen- dents per carcass. sion. 10 Wingtip compound fracture —Example: Ingesta, grease, —Same criteria as line 9, but or unidentifiable foreign only for wingtips. material.

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TABLE 1—DEFINITIONS OF which birds shall be salvaged, reproc- NONCONFORMANCESÐContinued essed, condemned, retained for disposi- —Factor is one. tion by the veterinarian, or allowed to —3 to 7=1 defect; 8 to 12=2 defects; 13 or more=3 defects. proceed down the line as a passed bird A maximum of three inci- subject to reinspection. Poultry car- dents per carcass. casses with certain defects not requir- 2 Extraneous material >1⁄16″ to ing condemnation of the entire carcass 1″ and specified in the partial quality —This includes ingesta, control agreement as defects the estab- grease, or unidentifiable lishment shall remove, shall be passed foreign material by the inspector, but shall be subject measureing >1⁄16″ to 1″ longest dimension. to reinspection to ensure the physical —Factor is one. removal of the specified defects. The —A maximum of three inci- helper, under the supervision of the in- dents per carcass. spector, shall mark such carcasses for 3 Extraneous material >1″ trim when the defects are not readily —The same material as line observable. Trimming of birds passed 2, but measuring greater than one inch. subject to reinspection shall be per- —Factor is two. formed by: —A maximum of two inci- (1) The helper, time permitting, and dents per carcass. (2) One or more plant trimmers posi- TABLE 2—FINISHED PRODUCT STANDARDS tioned after giblet harvest and prior to reinspection. SIS (b) A reinspection station shall be lo- Prechill Processing Nonconformance cated at the end of each line. This sta- Tolerance number (T) ...... 25 tion shall comply with the facility re- Subgroup Absolute Limit (T+5) ...... 30 quirements in § 381.36(d)(2). The inspec- Action number ...... 22 tor shall ensure that the establishment Start number ...... 11 has performed the indicated trimming Prechill Trim Nonconformance of carcasses passed subject to reinspec- Tolerance number (T) ...... 12 Subgroup Absolute Limit (T+5) ...... 17 tion by visually monitoring, checking Action number ...... 15 data, and/or gather samples at the sta- Start number ...... 8 tion and at other critical points on the Postchill Nonconformance line. Specific reinspection activities Tolerance number (T) ...... 5 shall be based on the establishment’s Subgroup Absolute Limit (T+5) ...... 10 partial quality control system and its Action number ...... 10 Start number ...... 5 performance under that system as determined by the inspector. (4) The following requirements are (ii) The approved quality control pro- also applicable to NELS inspection: gram for the establishment shall in- (i) Inspection under NELS is con- clude critical control points on the ducted in two phases, as post-mortem line, which shall be monitored by the inspection phase and a reinspection inspector. Establishment quality con- phase. trol employees shall operate the poul- (a) Post-mortem inspection. The es- try carcass on-line quality control pro- tablishment shall provide three inspec- gram and shall make immediately tion stations on each eviscerating line available to inspection personnel any in compliance with the facility require- and all data collected and maintained ments § 381.36(d)(1). The three inspec- under the approved partial quality con- tors shall inspect the inside, viscera, trol program. and outside of all birds presented. Each inspector shall be flanked by two es- (iii) An inspector shall monitor the tablishment employees—the presenter establishment’s application of the and the helper. The presenter shall en- poultry carcass on-line quality control sure that the bird is properly evis- program and shall take corrective ac- cerated and presented for inspection tion when he/she determines that the and the viscera uniformly trailing or establishment has failed to maintain or leading. The inspector shall determine correct its process as described in the approved quality control program.

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(iv) The maximum inspection rate for (2) One or more plant trimmers posi- NELS shall be 91 birds per minute per tioned after the giblet harvest and eviscerating line. prior to reinspection. (5) The following requirements are (b) Reinspection. A reinspection sta- also applicable to the NTI System: tion shall be located at the end of the (i) Inspection under the NTI System lines. This station shall comply with is conducted in two phases, a post- the facility requirements in mortem inspection phase and a rein- § 381.36(e)(2). The inspector shall ensure spection phase. The NTI–1 Inspection that establishments have performed System requires that the establish- the indicated trimming of each carcass ment provide one inspection station for passed subject to reinspection by vis- each line and adequate reinspection ually monitoring, checking data, and/ facilitiates so carcasses can be re- or sampling product at the reinspec- moved from each line for evaluation. tion station and, if necessary, at other The NTI–2 Inspection System requires points, critical to the wholesomeness that the establishment provide two in- of product, on the eviscerating line. spection stations for each line and ade- Specific reinspection activities shall be quate reinspection facilities so car- based on the establishment’s partial casses can be removed from each line quality control program described in for evaluation. paragraph (d) of this section and its performance under that program as de- (a) Post-mortem inspection. Each in- termined by the inspector. spection station must comply with the (ii) The approved partial quality con- facility requirements in § 381.36(e)(1). trol program described in paragraph (c) Each inspector shall be flanked by an of this section for the establishment establishment employee assigned to be shall include critical control points on the inspector’s helper. The one inspec- the eviscerating line, which shall be tor on an NTI–1 Inspection System monitored by the inspector. Establish- shall be presented every bird. Each in- ment quality control employees shall spector on an NTI–2 Inspection System operate the quality control program, line shall be presented every other bird and shall make immediately available on the line. An establishment employee to inspection personnel any and all shall present each bird to the inspector data collected and maintained under properly eviscerated with the back side the partial quality control program. toward the inspector and the viscera (iii) An inspector shall monitor the uniformly trailing or leading. Each in- establishment’s application of the spector shall inspect the inside, quality control program described in viscera, and outside of all birds pre- paragraph (c) of this section and shall sented. The inspector shall determine take corrective action when he/she de- which bird shall be salvaged, reproc- termines that the establishment has essed, condemned, retained for disposi- failed to maintain or correct its proc- tion by a veterinarian, or allowed to ess as described in the approved partial proceed down the line as a passed bird quality control program. subject to trim and reinspection. Tur- (c) Applying for and terminating the key carcasses with certain defects not Partial Quality Control Agreements for requiring condemnation of the entire the NELS Inspection System and the carcass and specified in the partial NTI System. quality control program described in (1) Any owner or operator of an offi- paragraph (d) of this section as defects cial establishment preparing poultry the establishment shall remove, shall products who wishes to apply for the be passed by the inspector, but shall be NELS Inpsection System or NTI Sys- subject to reinspection to ensure the tem must submit to the Administrator physical removal of the specified de- a partial quality control program defects. The helper, under the supervision signed to assure that poultry is whole- of the inspector, shall mark such car- some and properly prepared and shall casses for trim when the defects of request a determination as to whether birds passed subject to reinspection or not that program is adequate to re- shall be performed by: sult in product being in compliance (1) The helper, time permitting, and with the requirements of the Act and,

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therefore, qualify for the NELS Inspec- corrective action—ranging from the tion System or NTI System. Such a re- least to the most severe. quest shall, as a minimum, include: (2)(i) The Administrator shall evalu- (i) A letter to the Administrator ate the submitted partial quality con- from the establishment owner or opera- trol program in accordance with the tor stating the objective of the pro- provisions of this paragraph. If it is de- gram and willingness to adhere to the termined by the Administrator that requirements of the program as ap- the partial quality control program proved by the Department; that all will result in finished products being in data and information generated under full compliance with the requirements the program will be maintained and be of the Act and regulations thereunder, available to departmental personnel to the partial quality control program enable the Department to monitor will be approved and implemented, compliance; that establishment quality under departmental supervision, as control personnel will have authority soon thereafter as practicable. to halt production or shipping of prod- (ii) In any situation where the pro- uct in cases where the submitted qual- gram is found by the Administrator to ity control program requires it; and be unacceptable, written notification that the owner or operator (or his/her shall be given to the applicant of the designee) will be available for consulta- basis for the denial. The applicant will tion at any time departmental person- be afforded a reasonable opportunity to nel consider it necessary. modify the program in accordance with (ii) Identification of establishment the notification. The applicant shall partial quality control personnel re- also be afforded a reasonable oppor- sponsible for the partial control pro- tunity to submit a written statement gram. In the case of an establishment in response to this notification of de- having one or more full-time persons nial and/or to request a hearing on the whose primary duties are related to the denial. If the applicant requests a hear- partial quality control program, the re- ing and the Administrator, after review quest shall also include agreement that of the applicant’s answer to the notice, such people shall ultimately report to finds the initial determination to be an establishment official whose partial correct, the applicant must file with quality control responsibilities are the Hearing Clerk of the Food Safety independent of or not predominantly and Inspection Service the notifica- production responsibilities. In the case tion, answer, and the request for hear- of an establishment which does not ing, which shall constitute the com- have full-time quality control person- plaint and answer in the proceeding, nel, detailed information indicating which shall thereafter be conducted in the nature of the duties and respon- accordance with Rules of Practice sibilities of the person who will be which shall be adopted for this proceed- responbile for the quality control pro- ing. gram shall be included. (iii) The approved partial quality (iii) Detailed information concerning control program constitutes an operat- the manner in which the program will ing agreement between the establish- function. Such information shall in- ment and the Department. The estab- clude, but not be limited to, the criti- lishment owner or operator shall be re- cal check or control points on each sponsible for the effective operation of eviscerating line from the unloading the approved partial quality control area to the finished product, the nature program, and for obtaining approval of and frequency of tests to be made at any changes required in that program, each check or critical point, the nature to assure continuing compliance with of charts and other records that will be the requirements of the Act and regu- maintained by the official establish- lations thereunder. The Secretary shall ment, the type of deficiencies the pro- provide the Federal inspection nec- gram is designed to identify and con- essary, as determined by the operating trol, the defect criteria which will be conditions at the establishment, to used and the points at which corrective carry out his responsibilities under the action will occur and the nature of the Act.

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(3) The approval of the partial qual- under (i) Traditional Inspection or ity control program under the NELS Streamlined Inspection System if pre- Inspection System or the NTI System viously operating under the NELS In- may be terminated at any time by the spection System, or (ii) Traditional In- owner or operator of the official estab- spection if previously operating under lishment upon written notice to the the NTI System, provided all require- Administrator. Establishments which ments of the Act and regulations there- operated under the NELS Inspection under are met. System will be provided inspection under either Traditional Inspection or (Recordkeeping requirements approved by Streamlined Inspection System, as ap- the Office of Management and Budget under propriate. Establishments which oper- control number 0583–0008) ated under the NTI System will be pro- [47 FR 23435, May 28, 1982, as amended at 49 vided inspection under the Traditional FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, Inspection procedure. 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, (4) The approval of the partial qual- Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988] ity control programs under the NELS Inspection System or the NTI System § 381.77 Carcasses held for further ex- will terminate upon receipt by the es- amination. tablishment of written notice from the Each carcass, including all parts Administrator (or his designee). Such thereof, in which there is any lesion of notice will specify the deficiency and disease, or other condition which will be issued: might render such carcass or any part (i) If unwholesome or otherwise adul- thereof adulterated and with respect to terated poultry products are found by which a final decision cannot be made the Administrator to have been pre- on first examination by the inspector, pared for or distributed in commerce shall be held for further examination. by the subject establishment, or The identity of each such carcass, in- (ii) If the establishment fails to com- cluding all parts thereof, shall be main- ply with the partial quality control tained until a final examination has program to which it has agreed. been completed. (5) The establishment owner or operator receiving notice that approval has § 381.78 Condemnation of carcasses terminated may respond to the notice, and parts: separation of poultry in writing, to the Administrator within suspected of containing biological 30 days or receipt of such notice. In residues. those instances where there are issues (a) At the time of any inspection of fact, a hearing under applicable under this subpart each carcass, or any Rules of Practice will be provided to the establishment owner or operator to part thereof, which is found to be adul- resolve the conflict. The Administra- terated shall be condemned, except tor’s termination of approval shall re- that any such articles which may be main in effect pending the final deter- made not adulterated by reprocessing, mination of the proceeding. need not be so condemned if so reproc- (6) If approval of the partial quality essed under the supervision of an in- control program under the NELS In- spector and thereafter found to be not spection System or the NTI System adulterated. has been terminated in accordance (b) When a lot of poultry suspected of with the provisions of this section, an containing biological residues is in- application and request for approval of spected in an official establishment, all the same or modified quality control carcasses and any parts of carcasses in program will not be evaluated by the such lot which are condemned shall be Administrator for at least 2 months kept separate from all other con- from the termination date. In order for demned carcasses or parts. the Department to provide the Federal inspection required under the Act, an [37 FR 9706, May 16, 1972, as amended at 48 establishment whose partial quality FR 22899, May 23, 1983; 48 FR 23807, May 27, control program has been terminated 1983] will be allowed to continue operating

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§ 381.79 Passing of carcasses and § 381.84 Airsacculitis. parts. Carcasses of poultry with evidence of Each carcass and all organs and extensive involvement of the air sacs other parts of carcasses which are with airsacculitis or those showing found to be not adulterated shall be airsacculitis along with systemic passed for human food. changes shall be condemned. Less affected carcasses may be passed for food § 381.80 General; biological residues. after complete removal and condemna- (a) The carcasses or parts of car- tion of all affected tissues including casses of all poultry inspected at an of- the exudate. ficial establishment and found at the time of post mortem inspection, or at [40 FR 14297, Mar. 31, 1975] any subsequent inspection, to be af- § 381.85 Special diseases. fected with any of the diseases or conditions named in other sections in this Carcasses of poultry showing evi- subpart, shall be disposed of in accord- dence of any disease which is charac- ance with the section pertaining to the terized by the presence, in the meat or disease or condition. Owing to the fact other edible parts of the carcass, or or- that it is impracticable to formulate ganisms or toxins dangerous to the rules for each specific disease or condi- consumer, shall be condemned. tions and to designate at just what stage a disease process results in an § 381.86 Inflammatory processes. adulterated article, the decision as to Any organ or other part of a carcass the disposal of all carcasses, organs or which is affected by an inflammatory other parts not specifically covered by process shall be condemned and, if the regulations, or by instructions of there is evidence of general systemic the Administrator issued pursuant disturbance, the whole carcass shall be thereto, shall be left to the inspector in condemned. charge, and if the inspector in charge is in doubt concerning the disposition to § 381.87 Tumors. be made, specimens from such carcasses shall be forwarded to the Inspec- Any organ or other part of a carcass tion Service laboratory for diagnosis. which is affected by a tumor shall be (b) All carcasses, organs, or other condemned and when there is evidence parts of carcasses of poultry shall be of metastasis or that the general condi- condemned if it is determined on the tion of the bird has been affected by basis of a sound statistical sample that the size, position, or nature of the they are adulterated because of the tumor, the whole carcass shall be con- presence of any biological residues. demned.

§ 381.81 Tuberculosis. § 381.88 Parasites. Carcasses of poultry affected with tu- Organs or other parts of carcasses berculosis shall be condemned. which are found to be infested with parasites, or which show lesions of § 381.82 Diseases of the leukosis com- such infestation shall be condemned plex. and, if the whole carcass is affected, Carcasses of poultry affected with the whole carcass shall be condemned. any one or more of the several forms of the avian leukosis complex shall be § 381.89 Bruises. condemned. Any part of a carcass which is badly bruised shall be condemned and, if the § 381.83 Septicemia or toxemia. whole carcass is affected as a result of Carcasses of poultry showing evi- the bruise, the whole carcass shall be dence of any septicemic or toxemic dis- condemned. Parts of a carcass which ease, or showing evidence of an abnor- show only slight reddening from a mal physiologic state, shall be con- bruise may be passed for food. demned.

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§ 381.90 Cadavers. pable of removing all visible specks of Carcasses of poultry showing evi- contamination on the inner surface of dence of having died from causes other a carcass, he may withdraw approval of than slaughter shall be condemned. such area, effective upon oral or written notification, whichever is earlier, § 381.91 Contamination. to the operator of the establishment. In the event of oral notification, a (a) Carcasses of poultry contami- written confirmation thereof shall be nated by volatile oils, paints, poisons, given to the operator as promptly as gases, scald vat water in the air sac circumstances permit. The notification system, or other substances which shall specify the reasons for such with- render the carcasses adulterated shall drawal and shall afford the operator of be condemned. Any organ or other part the establishment an opportunity to of a carcass which has been acciden- present his views. In any instance tally multilated in the course of processing shall be condemned, and if the where there is a conflict as to the whole carcass is affected, the whole facts, a hearing shall be held to resolve carcass shall be condemned. such conflict. (b)(1) Any carcass of poultry acciden- [37 FR 9706, May 16, 1972, as amended at 43 tally contaminated during slaughter FR 12847, Mar. 28, 1978] with digestive tract contents shall not be condemned if promptly reprocessed § 381.92 Overscald. under the supervision of an inspector Carcasses of poultry which have been and thereafter found not to be adulter- overscalded, resulting in a cooked ap- ated. Contaminated surfaces that are pearance of the flesh, shall be con- cut shall be removed only by trimming. demned. Contaminated inner surfaces that are not cut may be cleaned by trimming § 381.93 Decomposition. alone, or at an approved reprocessing Carcasses of poultry deleteriously af- station away from the main processing fected by post mortem changes shall be line, by any method that will remove disposed of as follows: the contamination, such as vacuuming, (a) Carcasses which have reached a washing, and trimming, singly or in state of putrefaction or stinking fer- combination. All visible specks of con- mentation shall be condemned. tamination must be removed, and if (b) Any part of a carcass which is the inner surfaces are reprocessed green struck shall be condemned and, if other than soley by trimming, all sur- the carcass is so extensively affected faces of the carcass shall be treated that removal of affected parts is im- with chlorinated water containing 20 practicable, the whole carcass shall be ppm available chlorine. condemned. (2) An area will be designated as an (c) Carcasses affected by types of post approved reprocessing station only if mortem change which are superficial the Administrator determines that rein nature may be passed for human processing operations can be conducted food after removal and condemnation in that area in accordance with all of of the affected parts. the requirements of this part, and that the reprocessing methods to be utilized § 381.94 Contamination with Micro- are capable of removing all visible organisms; process control verifica- specks of contamination on the inner tion criteria and testing; pathogen surface of a carcass. Requests for such reduction standards. approval shall be submitted to the in- (a) Criteria for verifying process con- spector in charge and shall describe the trol; E. coli testing. proposed area, proposed methods of re- (1) Each official establishment that processing, and proposed equipment to slaughters poultry shall test for be utilized. Whenever the Adminis- Escherichia coli Biotype I (E. coli) and trator finds that reprocessing oper- shall: ations cannot be conducted in such (i) Collect samples in accordance area in accordance with all of the re- with the sampling techniques, meth- quirements of this part or that the re- odology, and frequency requirements in processing methods utilized are not ca- paragraph (a)(2) of this section;

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(ii) Obtain analytic results in accord- ceeding 60,000 turkeys and 440,000 birds ance with paragraph (a)(3) of this sec- total, shall collect one sample per tion; and week starting the first full week of (iii) Maintain records of such ana- June through August of each year. An lytic results in accordance with para- establishment slaughtering both chick- graph (a)(4) of this section. ens and turkeys shall collect samples (2) Sampling requirements. from the species it slaughters in larger (i) Written procedures. Each establish- numbers. Weekly samples shall be col- ment shall prepare written specimen lected and tested until the establish- collection procedures which shall iden- ment has completed and recorded one tify employees designated to collect series of 13 tests that meets the cri- samples, and shall address location(s) teria shown in Table 1 of paragraph of sampling, how sampling randomness (a)(5) of this section. is achieved, and handling of the sample (B) Upon the establishment’s meeting to ensure sample integrity. The writ- the requirements of paragraph ten procedure shall be made available (a)(2)(v)(A) of this section, weekly sam- to FSIS upon request. pling and testing is optional, unless (ii) Sample collection. The establish- changes are made in establishment fa- ment shall collect random samples cilities, equipment, personnel or proce- from carcasses. Carcasses to be sam- dures that may affect the adequacy of pled will be selected randomly. Sam- existing process control measures, as ples shall be collected by taking a determined by the establishment or by whole bird from the end of the chilling FSIS. FSIS determinations that process, after the drip line, and rinsing changes have been made requiring re- it in an amount of buffer appropriate sumption of weekly testing shall be for the type of bird being tested. 1 provided to the establishment in writ- (iii) Sampling frequency. Samples will ing. be taken at a frequency proportional to (3) Analysis of samples. Laboratories a slaughter establishment’s volume of may use any quantitative method for production, at the following rates: analysis of E. coli that is sensitive to 5 Chickens: 1 sample per 22,000 carcasses or fewer cfu/ml of rinse fluid and is ap- Turkeys: 1 sample per 3,000 carcasses proved by the Association of Official (iv) Sampling frequency alternatives. Analytic Chemists International 2 or An establishment operating under a approved by a scientific body in col- validated HACCP plan in accordance laborative trials against the three tube with § 417.2(b) of this chapter may sub- Most Probable Number (MPN) method stitute an alternative frequency for the and agreeing with the 95 percent upper frequency of sampling required under and lower confidence limit of the ap- paragraph (a)(2)(iii) of this section if, propriate MPN index. (A) The alternative is an integral (4) Recording of test results. The estab- part of the establishment’s verification lishment shall maintain accurate procedures for its HACCP plan and, records of all test results, in terms of (B) FSIS does not determine, and no- cfu/ml of rinse fluid. Results shall be tify the establishment in writing, that recorded onto a process control chart the alternative frequency is inadequate or table showing at least the most re- to verify the effectiveness of the estab- cent 13 test results, by kind of poultry lishment’s processing controls. slaughtered, permitting evaluation of (v) Sampling in very low volume estab- the laboratory results in accordance lishments. with the criteria set forth in paragraph (A) An establishment annually (a)(5) of this section. Records shall be slaughtering no more than 440,000 chickens, 60,000 turkeys, or a combina- 2 A copy of the ‘‘Official Methods of Analy- tion of chickens and turkeys not ex- sis of the Association of Official Analytical Chemists International,’’ 16th edition, 1995, 1 A copy of FSIS’s guideline, ‘‘Sampling is on file with the Director, Office of the Fed- Technique for E. coli in Raw Meat and Poul- eral Register, and may be purchased from try for Process Control Verification,’’ is the Association of Official Analytical Chem- available in the FSIS Docket Room for in- ists International, Inc., 481 North Frederick spection. Ave., Suite 500, Gaithersburg, MD 20877–2417.

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retained at the establishment for a pecent E. coli test result does not exceed riod of 12 months and shall be made the upper limit (M), and the number of available to FSIS upon request. samples, if any, testing positive at lev- (5) Criteria for Evaluation of test re- els above (m) is three or fewer out of sults. An establishment is operating the most recent 13 samples (n) taken, within the criteria when the most re- as follows:

TABLE 1.ÐEVALUATION OF E. COLI TEST RESULTS

Maximum number Lower limit of Upper limit of Number of sample permitted in mar- Slaughter class marginal range marginal range tested ginal range (m) (M) (n) (c)

Broilers ...... 100 cfu/ml 1,000 cfu/ml 13 3 Turkeys ...... a N.A. N.A. N.A. N.A. a Not available; values for turkeys will be added upon completion of data collection program for turkeys.

(6) Failure to meet criteria. Test results visions of paragraphs (a) (1)–(4) of this that do not meet the criteria described section have not been complied with in paragraph (a)(5) of this section are and written notice of same has been an indication that the establishment provided to the establishment. may not be maintaining process con- (b) Pathogen reduction performance trols sufficient to prevent fecal con- standards; Salmonella. tamination. FSIS shall take further ac- (1) Raw poultry product performance tion as appropriate to ensure that all standards for Salmonella. (i) An estab- applicable provisions of the law are lishment’s raw poultry products, when being met. sampled and tested by FSIS for Sal- (7) Failure to test and record. Inspec- monella as set forth in this section, tion will be suspended in accordance may not test positive for Salmonella at with rules of practice that will be a rate exceeding the applicable na- adopted for such proceeding, upon a tional pathogen reduction performance finding by FSIS that one or more pro- standard, as provided in Table 2:

TABLE 2.ÐSALMONELLA PERFORMANCE STANDARDS

Performance Number of sam- Maximum number Class of product Standard (percent ples tested of positives to positive for Sal- (n) achieve Standard monella) a (c)

Broilers ...... b 20.0% 51 12 Ground chicken ...... 44.6 53 26 Ground turkey ...... 49.9 53 29 Turkeys ...... b N.A. N.A. N.A. a Performance Standards are FSIS's calculation of the national prevalence of Salmonella on the indicated raw products based on data developed by FSIS in its nationwide microbiological baseline data collection programs and surveys. (Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are avialable in the FSIS Docket Room.) b Standard is based on partial analysis of baseline survey data; subject to confirmation upon publication of baseline survey report. d Not available; baseline targets for turkeys will be added upon completion of the data collection programs for that product.

(2) Enforcement. FSIS will sample and ducing more than one class of product test raw poultry products in an individ- subject to the pathogen reduction ual establishment on an unannounced standard, FSIS may sample any or all basis to determine prevalence of Sal- such classes of products.3 monella in such products to determine compliance with the standard. The frequency and timing of such testing will 3 A copy of FSIS’s ‘‘Sample Collection be based on the establishment’s pre- Guidelines and Procedure for Isolation and vious test results and other informa- Identification of Salmonella from Raw Meat tion concerning the establishment’s and Poultry Products’’ is available for in- performance. In an establishment pro- spection in the FSIS Docket Room.

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(3) Noncompliance and establishment food purposes and preclude dissemina- response. When FSIS determines that tion of disease through consumption by an establishment has not met the per- animals. (Tanks and equipment used formance standard: for this purpose or for rendering or pre- (i) The establishment shall take im- paring inedible products shall be in mediate action to meet the standard. rooms or compartments separate from (ii) If the establishment fails to meet those used for the preparation of edible the standard on the next series of com- products. There shall be no direct con- pliance tests for that product, the es- nection by means of pipes, or other- tablishment shall reassess its HACCP wise, between tanks containing ined- plan for that product. ible products and those containing edi- (iii) Failure by the establishment to ble products.) act in accordance with paragraph (b) Incineration or complete destruc- (b)(3)(ii) of this section, or failure to tion by burning. meet the standard on the third con- (c) Chemical denaturing, which shall secutive series of FSIS-conducted tests be accomplished by the liberal applica- for that product, constitutes failure to tion to all carcasses and parts thereof, maintain sanitary conditions and fail- of: ure to maintain an adequate HACCP (1) Crude carbolic acid, plan, in accordance with part 417 of (2) Kerosene, fuel oil, or used crank- this chapter, for that product, and will case oil, or cause FSIS to suspend inspection serv- (3) Any phenolic disinfectant con- ices. Such suspension will remain in ef- forming to commercial standards CS fect until the establishment submits to 70–41 or CS 71–41 which shall be used in the FSIS Administrator or his/her des- at least 2 percent emulsion or solution. ignee satisfactory written assurances (d) Any other substance or method detailing the action taken to correct that the Administrator approves in the HACCP system and, as appropriate, specific cases, which will denature the other measures taken by the establish- poultry product to the extent nec- ment to reduce the prevalence of essary to accomplish the purposes of pathogens. this section. (e) Carcasses and parts of carcasses [61 FR 38866, July 25, 1996] condemned for biological residue shall be disposed of in accordance with para- Subpart L—Handling and Disposal graph (b) of this section or by burying of Condemned or Other Ined- under the supervision of an inspector. ible Products at Official Estab- lishments Subpart M—Official Marks, De- vices, and Certificates; Export § 381.95 Disposal of condemned poul- Certificates; Certification Pro- try products. cedures All condemned carcasses, or condemned parts of carcasses, or other § 381.96 Wording and form of the offi- condemned poultry products, except cial inspection legend. those condemned for biological resi- Except as otherwise provided in this dues shall be disposed of by one of the subpart, the official inspection legend following methods, under the super- required to be used with respect to in- vision of an inspector of the Inspection spected and passed poultry products Service. (Facilities and materials for shall include wording as follows: ‘‘In- carrying out the requirements in this spected for wholesomeness by U.S. De- section shall be furnished by the offi- partment of Agriculture.’’ This word- cial establishment.) ing shall be contained within a circle. (a) Steam treatment (which shall be The form and arrangement of such accomplished by processing the con- wording shall be exactly as indicated in demned product in a pressure tank the example in Figure 1, except that under at least 40 pounds of steam pres- the appropriate official establishment sure) or thorough cooking in a kettle number shall be shown, and if the es- or vat, for a sufficient time to effec- tablishment number appears elsewhere tively destroy the product for human on the labeling material in the manner

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prescribed in § 381.123(b), it may be omitted from the inspection mark. The administrator may approve the use of abbreviations of such inspection mark; and such approved abbreviations shall have the same force and effect as the inspection mark. The official inspection legend, or the approved abbreviation thereof, shall be printed on consumer packages and other immediate containers of inspected and passed poultry products, or on labels to be securely affixed to such containers. Further, such legend or approved abbreviation thereof, shall be applied to shipping containers of such products and may be printed or stenciled thereon, but shall not be applied by rubber stamping. When applied by a stencil, the legend shall be not less than 4 inches in diameter. § 381.97 [Reserved] § 381.98 Official seal. The official mark for use in sealing means of conveyance used in transporting poultry products under any requirement in this part shall be the inscription and a serial number as shown below, and any seals approved by the Administrator for applying such mark shall be an official device.

§ 381.99 Official retention and rejec- made acceptable. The Administrator tion tags. has approved a paper tag (a portion of An inspector may use such tags or Form MP–35) bearing the legend, ‘‘U.S. other devices and methods at an offi- Retained’’ for use on poultry or poultry cial establishment as may be approved products under this section, and has by the Administrator for the identi- approved a paper tag (another portion fication and control of (a) poultry and of Form C&MS 510) bearing the legend poultry products which appear to be ‘‘U.S. Rejected’’ for use on equipment, not in compliance with the regulations utensils, rooms and compartments or which are held for further examina- under this section. Such tags are offi- tion and (b) any equipment, utensils, cial devices and shall not be removed rooms, or compartments at such estab- by anyone other than an inspector. lishments which are found to be un- [39 FR 9706, May 16, 1972, as amended at 39 clean or otherwise in violation of any FR 36000, Oct. 7, 1974] of the regulations. No poultry, poultry product, or other article, or equipment, § 381.100 Official detention tag. utensil, room, or compartment so iden- The detention tag prescribed in tified shall be used until it has been § 381.211 is an official device.

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§ 381.101 Official U.S. Condemned the Department to apply such a mark mark. are official devices. The term ‘‘U.S. Condemned’’ as shown below is an official mark and the devices used by the Department for applying such mark are official devices.

§ 381.102 [Reserved] [47 FR 29823, July 9, 1982]

§ 381.103 Official poultry condemna- § 381.105 Export certification; marking tion certificates; issuance and form. of containers. Upon request by the operator of the (a) Upon request or application by establishment, the inspector in charge any person intending to export any shall issue a poultry condemnation cer- poultry product, any inspector is au- tificate (Form MP–514–1), showing the thorized to issue an official export cer- total number of poultry in the lot and tificate as prescribed in § 381.107 with the numbers condemned and the rea- respect to the shipment to any foreign sons for such condemnations. country of any inspected and passed The official poultry condemnation poultry product, after adequate inspec- certificate authorized by this subpart tion of the product has been made by is a paper certificate (Form MP–514–1), the inspector to determine its identity for signature by an inspector, bearing as inspected and passed and eligible for the legend export: Provided, that the product is offered for inspection at an official estab- U.S. DEPARTMENT OF AGRICULTURE ANIMAL lishment. Each shipping container cov- AND PLANT HEALTH INSPECTION SERVICE ered by the export certificate, except ship stores, small quantities exclu- POULTRY CONDEMNATION CERTIFICATE sively for the personal use of the con- and the seal of the United States De- signee and not for sale or distribution, partment of Agriculture, with a certifi- and shipments by and for the U.S. cation that the poultry enumerated on Armed Forces, shall be marked with an the form were inspected and con- official export stamp as shown in demned for the listed causes in compli- § 381.104 bearing the number of the ex- ance with the regulations of the De- port certificate. Official export certifi- partment. A statement to the effect cates will be issued only upon condi- that certain figures on the certificate tion that the products covered thereby were derived from information supplied shall be subject to reinspection at any by plant management, and a signature place and at any time prior to expor- line for an authorized plant official is tation to determine the identity of the also shown. products and their eligibility for certification, and such certificates shall § 381.104 Official export certificates, become invalid if such reinspection is marks and devices. refused or discloses that the products The form of certificate described in are not eligible for certification. If re- § 381.106 is an official export certificate, inspection discloses that any poultry and the mark shown below is the offi- products covered by an export certifi- cial mark used on outside containers to cate are not eligible for such certifi- identify inspected and passed poultry cation, a superseding certificate set- products for export. Devices used by ting forth such findings shall be issued

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and copies shall be furnished to inter- trator may prescribe or approve in spe- ested persons. cific cases. (b) The original and a duplicate of [47 FR 29823, July 9, 1982] each official export certificate shall be delivered to the person who requested § 381.107 Special procedures as to cer- such certificate or his agent. Such per- tification of poultry products for ex- son may duplicate such numbers of port to certain countries. exact copies of the original as he re- When export certificates are required quires in connection with the expor- by any foreign country for poultry tation of the poultry products. Addi- products exported to such country, the tional official file copies of the export Administrator shall in specific cases certificates shall be prepared and dis- prescribe or approve the form of export tributed by the inspector in accordance certificate to be used and the methods with the instructions of the Adminis- and procedures he deems appropriate trator. with respect to the processing of such (c) Only one certificate shall be is- products, in order to comply with requirements specified by the foreign sued for each consignment, except in country regarding the export products. case of error in the certificate or loss Inspectors shall satisfy themselves of the certificate originally issued. A that all such requirements are met be- request for a new certificate, except in fore issuing such an export certificate. the case of a lost certificate, shall be It shall be the responsibility of the ex- accompanied by the original and all porter to provide any unofficial docu- copies of the first certificate. The new mentation needed to meet the foreign certificate shall carry the following requirements, before the export certifi- statement: ‘‘This certificate supersedes cate will be issued. Such certificates certificate No. ——— Dated —————. may also cover articles exempted from The outside container of the poultry definition as a poultry product under product covered by this certificate is § 381.15 if they have been inspected and stamped with United States Depart- are certified under the regulations in ment of Agriculture Certificate No. part 362 of this chapter. ———.’’ [37 FR 9706, May 16, 1972, as amended at 39 [37 FR 9706, May 16, 1972, as amended at 50 FR 4569, Feb. 5, 1974; 41 FR 23702, June 11, FR 25204, June 18, 1985] 1976]

§ 381.106 Form of official export cer- § 381.108 Official poultry inspection tificate. certificates; issuance and disposition. The official export certificate au- (a) Upon the request of an interested thorized by this subpart is a paper cer- party, any veterinary inspector is au- tificate form for signature by an in- thorized to issue an official poultry inspector, bearing a letterhead and the spection certificate with respect to any seal of the U.S. Department of Agri- lot of slaughtered poultry inspected by culture, with a certification that the him. At any official establishment slaughtered poultry and other poultry each such certificate shall be signed by products described on the form came the inspector who made the inspection from birds that were officially given an covered by the certificate, and if more ante-mortem and post-mortem inspec- than one inspector participated in the tion and passed in accordance with the inspection of the lot of poultry, each regulations of the Department and that such inspector shall sign the certificate such products are wholesome and fit with respect to such lot. If the inspec- for human consumption. The certifi- tion of a lot covered by a certificate cate also bears a serial number, such as was made by a food inspector, such cer- ‘‘MPA 002805’’, and shows the respec- tificate shall also be signed by the in- tive names of the exporter and con- spector in charge when such inspection signee, the destination, the shipping was made. Any inspector is authorized marks, the names of such products, the to issue a poultry inspection certificate total net weight thereof, and such with respect to any other poultry prod- other information as the Adminis- uct inspected by him.

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(b) The original and one copy of each forwarded to the appropriate program poultry inspection certificate shall be supervisor. issued to the applicant who requested such certificate, and one copy shall be § 381.111 Data to be entered in proper retained by the inspector for filing. spaces. The inspector who issues any inspec- All certificates shall be so executed tion certificate is authorized to furnish that the data entered thereon will ap- an additional copy of such certificate pear in the proper spaces on each copy upon the request of an interested of the certificate. party. The person who sold the live poultry involved to the official estab- § 381.112 Official mark for maintaining lishment is an interested party for pur- the identity and integrity of sam- poses of this section. ples. [37 FR 9706, May 16, 1972, as amended at 39 The official mark for use in sealing FR 36000, Oct. 7, 1974] containers of samples submitted under any requirements in this part and sec- § 381.109 Form of official poultry in- tion 11(b) of the Poultry Products In- spection certificate. spection Act shall bear the designation (a) The official poultry inspection ‘‘Sample Seal’’ accompanied by the of- certificate authorized by this subpart ficial USDA logo as shown below. Any is a paper certificate (Form MP–505) for seal approved by the Administrator for signature by an inspector, bearing the applying such mark shall be deemed an legend official device for purposes of the Act. Such device shall be supplied to inspec- U.S. DEPARTMENT OF AGRICULTURE ANIMAL tors, compliance officers, and other AND PLANT HEALTH INSPECTION SERVICE MEAT AND POULTRY INSPECTION PROGRAM designated Agency officials by the United States Department of Agri- POULTRY INSPECTION CERTIFICATE culture. and the seal of the U.S. Department of Agriculture, with a certification that the poultry described therein had been inspected in compliance with the Regu- lations of the Secretary of Agriculture Governing the Inspection of Poultry and Poultry Products. (b) The certificate also bears a serial number such as ‘‘B 3208’’ and shows the respective name and address of the applicant, the shipper or seller and the [52 FR 41958, Nov. 2, 1987] receiver or buyer and the net weight in pounds of amount passed, amount rejected or condemned, type of poultry, Subpart N—Labeling and lot number and class, and such other Containers information as the Administrator may prescribe or approve in specific cases. § 381.115 Containers of inspected and passed poultry products required to § 381.110 Erasures or alterations made be labeled. on certificates. Except as may be authorized in spe- Erasures or alterations not initialed cific cases by the Administrator with by the issuing inspector shall not be respect to shipment of poultry prod- permitted on any official certificate or ucts between official establishments, any copy thereof. All certificates ren- each shipping container and each im- dered useless through clerical error or mediate container of any inspected and otherwise and all certificates canceled passed poultry product shall at the for whatever cause shall be voided and time it leaves the official establish- initialed, and one copy shall be re- ment bear a label which contains infor- tained in the inspector’s file; and the mation, and has been approved, in ac- original and all other copies shall be cordance with this subpart.

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§ 381.116 Wording on labels of imme- §§ 381.118, 381.122, and 381.123. Such diate containers. panel shall be known as the ‘‘20 percent (a) Each label for use on immediate panel’’ and such information may be containers for inspected and passed shown on that panel in lieu of showing poultry products shall bear on the prin- it on the principal display panel as pro- cipal display panel (except as otherwise vided in this § 381.116. permitted in the regulations), the (3) In the case of a container of any items of information required by this other shape, 40 percent of the total sur- subpart. Such items of information face of the container. shall be in distinctly legible form. Ex- In determining the area of the prin- cept as provided in § 381.128, all words, cipal display panel, exclude tops, bot- statements and other information re- toms, flanges at tops and bottoms of quired by or under authority of the Act cans, and shoulders and necks of bot- to appear on the label or labeling shall tles or jars. appear thereon in the English lan- (c) (1) The information panel is that guage: Provided, however, That in the part of a label that is the first surface case of products distributed solely in to the right of the principal display Puerto Rico, Spanish may be substituted for English for all printed panel as observed by an individual fac- matter except the USDA inspection ing the principal display panel, with legend. the following exceptions: (b) The principal display panel shall (i) If the first surface to the right of be the part of a label that is most like- the principal display panel is too small ly to be displayed, presented, shown, or to accommodate the required informa- examined under customary conditions tion or is otherwise unusable label of display for sale. The principal dis- space, e.g., folded flaps, tear strips, play panel shall be large enough to ac- opening flaps, heat-sealed flaps, the commodate all the mandatory label in- next panel to the right of this part of formation required to be placed there- the label may be used. on by the regulations with clarity and (ii) If the package has one or more al- conspicuousness and without being ob- ternate principal display panels, the in- scured by design or vignettes, or formation panel is to the right of any crowding. Where packages bear alter- principal display panel. nate principal display panels, informa- (iii) If the top of the container is the tion required to be placed on the prin- principal display panel and the pack- cipal display panel shall be duplicated age has no alternate principal display on each principal display panel. The panel, the information panel is any area that is to bear the principal dis- panel adjacent to the principal display play panel shall be: panel. (1) In the case of a rectangular pack- (2) (i) Except as otherwise permitted age, one entire side, the area of which in this part, all information required to is the product of the height times the appear on the principal display panel width of that side. or permitted to appear on the informa- (2) In the case of a cylindrical or tion panel shall appear on the same nearly cylindrical container: panel unless there is insufficient space. (i) An area on the side of the con- In determining the sufficiency of the tainer that is 40 percent of the product available space, except as otherwise of the height of the container times the prescribed in this part, any vignettes, circumference, or designs, and any other nonmandatory (ii) A panel, the width of which is information shall not be considered. If one-third of the circumference and the there is insufficient space for all re- height of which is as high as the con- quired information to appear on a sin- tainer: Provided, however, That there is, gle panel, it may be divided between immediately to the right or left of such the principal display panel and the in- principal display panel, a panel which formation panel, provided that the in- has a width not greater than 20 percent formation required by any given provi- of the circumference and a height as sion of this part, such as the ingredi- high as the container, and which is re- ents statement, is not divided and ap- served for information prescribed in pears on the same panel.

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(ii) All information appearing on the or the qualifying term ‘‘mature.’’ The information panel pursuant to this sec- name of the product for cooked or heat tion shall appear in one place without processed poultry products shall in- intervening material, such as designs clude the kind name of the poultry or vignettes. from which the product was prepared [37 FR 9706, May 16, 1972, as amended at 40 but need not include the class name or FR 11347, Mar. 11, 1975; 59 FR 40214, Aug. 8, the qualifying term ‘‘mature.’’ 1994] (c) Poultry products containing light and dark chicken or turkey meat in § 381.117 Name of product and other quantities other than the natural pro- labeling. portions, as indicated in Table 1 in this (a) The label shall show the name of paragraph, must have a qualifying the product, which, in the case of a statement in conjunction with the poultry product which purports to be name of the product indicating, as or is represented as a product for which shown in Table 1, the types of meat ac- a definition and standard of identity or tually used, except that when the prod- composition is prescribed in subpart P, uct contains less than 10 percent shall be the name of the food specified cooked deboned poultry meat or is in the standard, and in the case of any processed in such a manner that the other poultry product shall be the com- character of the light and dark meat is mon or usual name of the food, if any not distinguishable, the qualifying there be, and if there is none, a truth- statement will not be required, unless ful descriptive designation. the product bears a label referring to (b) The name of the product required the light or dark meat content. In the to be shown on labels for fresh or fro- latter case, the qualifying statement is zen raw whole carcasses of poultry required if the light and dark meat are shall be in either of the following not present in natural proportions. The forms: The name of the kind (such as qualifying statement must be in type chicken, turkey, or duck) preceded by at least one-half the size and of equal the qualifying term ‘‘young’’ or ‘‘ma- boldness as the name of the product; ture’’ or ‘‘old’’, whichever is appro- e.g., Boned Turkey (Dark Meat). priate; or the appropriate class name as described in § 381.170(a). The name of TABLE 1 the kind may be used in addition to the Percent Percent class name, but the name of the kind Label terminology light meat dark meat alone without the qualifying age or Natural proportions ...... 50±65 50±35 class term is not acceptable as the Light or white meat ...... 100 0 name of the product, except that the Dark meat ...... 0 100 name ‘‘chicken’’ may be used without Light and dark meat ...... 51±65 49±35 Dark and light meat ...... 35±49 65±51 such qualification with respect to a Mostly white meat ...... 66 or more 34 or less ready-to-cook pack of fresh or frozen Mostly dark meat ...... 34 or less 66 or more cut-up young chickens, or a half of a young chicken, and the name (d) Boneless poultry products shall be ‘‘duckling’’ may be used without such labeled in a manner that accurately de- qualification with respect to a ready- scribes their actual form and composi- to-cook pack of fresh or frozen young tion. The product name shall specify ducks. The class name may be appro- the form of the product (e.g., priately modified by changing the word emulsified, finely chopped, etc.), and form, such as using the term ‘‘roasting the kind name of the poultry, and if chicken’’, rather than ‘‘roaster.’’ The the product does not consist of natural appropriate names for cut-up parts are proportions of skin and fat, as they set forth in § 381.170(b). When naming occur in the whole carcass, shall also parts cut from young poultry, the iden- include terminology that describes the tity of both the kind of poultry and the actual composition. If the product is name of the part shall be included in cooked, it shall be so labeled. For the the product name. The product name purpose of this paragraph, natural pro- for parts or portions cut from mature portions of skin, as found on a whole poultry shall include, along with the chicken or turkey carcass, will be con- part or portion name, the class name sidered to be as follows:

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Percent present in an amount greater than the stated threshold. Such a quantifying Raw Cooked statement may also be utilized when Chicken ...... 20 25 an ingredients statement contains a Turkey ...... 15 20 listing of ingredients by individual components. Each component listing Boneless poultry product shall not may utilize the required quantifying have a bone solids content of more statement at the end of each compo- than 1 percent, calculated on a weight nent ingredients listing. basis. (ii) Such ingredients may be adjusted (e) On the label of any ‘‘Mechanically in the product formulation without a Separated (Kind of Poultry) ‘‘ described change being made in the ingredients in § 381.173, the name of such product statement on the labeling, provided shall be followed immediately by the that the adjusted amount complies phrase: ‘‘with excess skin’’ unless such with § 381.147(f)(4) and subpart P of this product is made from poultry product part, and does not exceed the amount that does not include skin in excess of shown in the quantifying statement. the natural proportion of skin present Any such adjustments to the formula- on the whole carcass, as specified in tion shall be provided to the inspector- paragraph (d) of this section. Appro- in-charge. priate terminology on the label shall (b) For the purpose of this paragraph, indicate if heat treatment has been the term ‘‘chicken meat,’’ unless modi- used in the preparation of the product. fied by an appropriate adjective, is con- The labeling information described in strued to mean deboned white and dark this paragraph shall be identified on meat; whereas the term ‘‘chicken’’ may the label before the product leaves the include other edible parts such as skin establishment at which it is manufac- and fat not in excess of their natural tured. proportions, in addition to the chicken [37 FR 9706, May 16, 1972, as amended at 60 meat. If the term ‘‘chicken meat’’ is FR 55983, Nov. 3, 1995] listed and the product also contains skin, giblets, or fat, it is necessary to § 381.118 Ingredients statement. list each such ingredient. Similar prin- (a)(1) The label shall show a state- ciples shall be followed in listing ingre- ment of the ingredients in the poultry dients of poultry products processed product if the product is fabricated from other kinds of poultry. from two or more ingredients. Such in- (c) The terms spice, natural flavor, gredients shall be listed by their com- natural flavoring, flavor or flavoring mon or usual names in the order of may be used in the following manner: their descending proportions, except as (1) The term ‘‘spice’’ means any aro- prescribed in paragraph (a)(2) of this matic vegetable substance in the section. whole, broken, or ground form, with (2)(i) Product ingredients which are the exceptions of onions, garlic and present in individual amounts of 2 per- celery, whose primary function in food cent or less by weight may be listed in is seasoning rather than nutritional the ingredients statement in other and from which no portion of any vola- than descending order of predomi- tile oil or other flavoring principle has nance: Provided, That such ingredients been removed. Spices include the spices are listed by their common or usual listed in 21 CFR 182.10, and 184. names at the end of the ingredients (2) The term ‘‘natural flavor,’’ ‘‘natu- statement and preceded by a quantify- ral flavoring,’’ ‘‘flavor’’ or ‘‘flavoring’’ ing statement, such as ‘‘Contains means the essential oil, oleoresin, es- lllll percent or less of lllll ,’’ sence or extractive, protein hydroly- or ‘‘Less than lllllpercent of sate, distillate, or any product of roast- lllll .’’ The percentage of the in- ing, heating or enzymolysis, which con- gredient(s) shall be filled in with a tains the flavoring constituents de- threshold level of 2 percent, 1.5 percent, rived from a spice, fruit or fruit juice, 1.0 percent, or 0.5 percent, as appro- vegetable or vegetable juice, edible priate. No ingredient to which the yeast, herb, bark, bud, root, leaf or any quantifying statement applies may be other edible portions of a plant, meat,

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seafood, poultry, eggs, dairy products, label, in prominent letters and contig- or fermentation products thereof, uous to the name of the product, a whose primary function in food is fla- statement such as ‘‘Artificial Smoke voring rather than nutritional. Natural Flavoring Added’’ or ‘‘Smoke Flavor- flavors include the natural essence or ing Added,’’ as applicable, and the in- extractives obtained from plants listed gredient statement shall identify any in 21 CFR 182.10, 182.20, 182.40, 182.50 and artificial smoke flavoring or smoke fla- 184, and the substances listed in 21 CFR voring added as an ingredient in the 172.510. The term natural flavor, natu- formula of the poultry product. ral flavoring, flavor or flavoring may (b) Any poultry product which bears also be used to designate spices, pow- or contains any artificial flavoring dered onion, powdered garlic, and pow- other than an artificial smoke flavor- dered celery. ing or a smoke flavoring, or bears or (i) Natural flavor, natural flavoring, contains any artificial coloring shall flavor or flavoring as described in para- bear a statement stating that fact on graph (c)(1) and (2) of this section, the immediate container or, if there is which are also colors shall be des- none, on the product. ignated as ‘‘natural flavor and coloring,’’ ‘‘natural flavoring and coloring,’’ § 381.120 Antioxidants; chemical pre- ‘‘flavor and coloring’’ or ‘‘flavoring and servatives; and other additives. coloring’’ unless designated by their common or usual name. When an antioxidant is added to a (ii) Any ingredient not designated in poultry product, there shall appear on paragraphs (c) (1) and (2) of this section the label in prominent letters and con- whose function is flavoring, either in tiguous to the name of the product, a whole or in part, must be designated by statement showing the name of the its common or usual name. Those in- antioxidant and the purpose for which gredients which are of livestock or it is added, such as ‘‘BHA added to help poultry origin must be designated by protect the flavor.’’ Immediate con- names that include the species and tainers of poultry products packed in, livestock and poultry tissues from bearing, or containing any chemical which the ingredients are derived. preservative shall bear a label stating (d) On containers of frozen dinners, that fact and naming the additive and entrees, and pizzas, and similarly the purpose of its use. Immediate con- packaged products in cartons, the in- tainers of poultry products packed in, gredient statement may be placed on bearing or containing any other chemi- the front riser panel: Provided, That cal additive shall bear a label naming the words ‘‘see ingredients,’’ followed the additive and the purpose of its use immediately by an arrow pointing to when required by the Administrator in the front riser panel, are placed on the specific cases. When approved principal display panel immediately proteolytic enzymes as permitted in above the location of such statement, § 381.147 of this subchapter are used in without intervening printing or de- mature poultry muscle tissue, there signs. shall appear on the label, in a promi- (e) The ingredients statement may be nent manner, contiguous to the prod- placed on the information panel, ex- uct name, the statement ‘‘Tenderized cept as otherwise permitted in this with [approved enzyme],’’ to indicate subchapter. the use of such enzymes. Any other approved substance which may be used in [37 FR 9706, May 16, 1972, as amended at 55 FR 7294, Mar. 1, 1990; 55 FR 26422, June 28, the solution shall also be included in 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, the statement. When approved inor- Aug. 8, 1994] ganic chlorides as permitted in § 381.147 of this subchapter are used in mature § 381.119 Declaration of artificial fla- poultry muscle tissue, there shall ap- voring or coloring. pear on the label, in a prominent man- (a) When an artificial smoke flavor- ner, contiguous to the product name, ing or a smoke flavoring is added as an the statement, ‘‘Tenderized with (name ingredient in the formula of any poul- of approved inorganic chloride(s))’’ to try product, there shall appear on the indicate the use of such inorganic

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chlorides. Any other approved sub- (c)), on the principal display panel of stance which may be used in the solu- all containers to be sold at retail in- tion shall also be included in the state- tact, in conspicuous and easily legible ment. boldface print or type, in distinct con- [37 FR 9706, May 16, 1972, as amended at 45 trast to other matter on the container, FR 58820, Sept. 5, 1980; 49 FR 18999, May 4, and shall be declared in accordance 1984] with the provisions of this paragraph (c). An unused tare weight, as defined § 381.121 Quantity of contents. in section 381.121b of this subchapter, (a) The label shall bear a statement may be printed adjacent to the state- of the quantity of contents in terms of ment of net quantity of contents when weight or measures as provided in the product is packaged totally with paragraph (c)(5) of this section. How- impervious packaging material and is ever, the Administrator may approve packed with a usable medium. the use of labels for certain types of (2) The statement shall be placed on consumer packages which do not bear a the principal display panel within the statement of the net weight that would bottom 30 percent of the area of the otherwise be required under this sub- panel, in lines generally parallel to the paragraph: Provided, That the shipping base: Provided, That on packages hav- container bears a statement ‘‘Net ing a principal display panel of 5 square weight to be marked on consumer inches or less, the requirement for packages prior to display and sale’’: placement within the bottom 30 per- And provided further, That the total net cent of the area of the label panel shall weight of the contents of the shipping not apply when the statement meets container is marked on such container: the other requirements of this para- And provided further, That the shipping graph. The declaration may appear in container bears a statement ‘‘Tare more than one line. weight of consumer package’’ and in (3) The statement shall be in letters close proximity thereto, the actual and numerals in type size established tare weight (weight of packaging mate- in relationship to the area of the prin- rial), weighed to the nearest one-eighth cipal display panel of the package and ounce or less, of the individual shall be uniform for all packages of consumer package in the shipping con- substantially the same size by comply- tainer. The above-specified statements ing with the following type specifica- may be added to approved shipping tions: container labels upon approval by the inspector in charge. (i) Not less than one-sixteenth inch (b) When a poultry product and a in height on containers, the principal nonpoultry product are separately display panel of which has an area of 5 wrapped and are placed in a single im- square inches or less; mediate container bearing the same (ii) Not less than one-eighth inch in name of both products, the net weight height on containers, the principal dis- on such immediate container may be play panel of which has an area of more the total net weight of the products, or than 5 but not more than 25 square such immediate container may show inches; the net weights of the poultry product (iii) Not less than three-sixteenth and the nonpoultry product separately. inch in height on containers, the prin- Notwithstanding the other provisions cipal display panel of which has an of this paragraph, the label on area of more than 25 but not more than consumer size retail packages of 100 square inches; stuffed poultry and other stuffed poul- (iv) Not less than one-quarter inch in try products must show the total net height on containers, the principal dis- weight of the poultry product, and in play panel of which has an area of more close proximity thereto, a statement than 100 but not more than 400 square specifying the minimum weight of the inches; poultry in the product. (v) Not less than one-half inch in (c)(1) The statement of net quantity height on containers, the principal dis- of contents shall appear (except as oth- play panel of which has an area of more erwise permitted under this paragraph than 400 square inches.

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(vi) The ratio of height to width of fourths pound avoirdupois weight shall letters and numerals shall not exceed a be expressed as ‘‘Net Wt. 12 oz.’’; a dec- differential of 3 units to 1 unit (no laration of 11⁄2 pounds avoirdupois more than 3 times as high as it is weight shall be expressed as ‘‘Net Wt. wide). This height standard pertains to 24 oz. (1 lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 upper case or capital letters. When lb.),’’ or ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ How- upper and lower case or all lower case ever, on random weight packages the letters are used, it is the lower case statement shall be expressed in terms letter ‘‘o’’ or its equivalent that shall of pounds and decimal fractions of the meet the minimum standards. When pound, for packages over 1 pound, and fractions are used, each component nu- for packages which do not exceed 1 meral shall meet one-half the height pound the statement may be in decimal standards. fractions of the pound in lieu of ounces. (4) The statement shall appear as a The numbers may be written in pro- distinct item on the principal display vided the unit designation is printed. panel and shall be separated, from Paragraphs (c) (8) and (9) of this sec- other label information appearing to tion permit certain exceptions to this the left or right of the statement, by a paragraph for multi-unit packages, and space at least equal in width to twice random weight consumer size and the width of the letter ‘‘N’’ of the style small packages (less than 1⁄2 ounce), re- of type used in the quantity of con- spectively. tents statement and shall be separated (6) The statement as it is shown on a from other label information appearing label shall not be false or misleading above or below the statement by a and shall express an accurate state- space at least equal in height to the ment of the quantity of contents of the height of the lettering used in the container. Reasonable variations statement. caused by loss or gain of moisture dur- (5) The terms ‘‘net weight’’ or ‘‘net ing the course of good distribution wt.’’ shall be used when stating the net practices or by unavoidable deviations quantity of contents in terms of in good manufacturing practices will weight, and the term ‘‘net contents’’ or be recognized. Variations from stated ‘‘contents’’ when stating the net quan- quantity of contents shall be as pro- tity of contents in terms of fluid meas- vided in section 381.121b of this sub- ure. Except as provided in § 381.128, the chapter. The statement shall not in- statement shall be expressed in terms clude any term qualifying a unit of of avoirdupois weight or liquid meas- weight, measure, or count such as ure. Where no general consumer usage ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant to the contrary exists, the statement quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ shall be in terms of liquid measure, if or words of similar importance except the product is liquid, or in terms of as provided in paragraph (b) of this sec- weight if the product is solid, semi- tion. solid, viscous or a mixture of solid and (7) Labels for containers which bear liquid. On packages containing less any representation as to the number of than 1 pound or 1 pint, the statement servings contained therein shall bear, shall be expressed in ounces or frac- contiguous to such representation, and tions of a pint, respectively. On pack- in the same size type as is used for ages containing 1 pound or 1 pint or such representation, a statement of the more, and less than 4 pounds or 1 gal- net quantity of each such serving. lon, the statement shall be expressed (8) On a multiunit retail package, a as a dual declaration both in ounces statement of the quantity of contents and (immediately thereafter in paren- shall appear on the outside of the pack- thesis) in pounds, with any remainder age and shall include the number of in- in terms of ounces or common or deci- dividual units, the quantity of each in- mal fraction of the pound, or in the dividual unit, and, in parentheses, the case of liquid measure, in the largest total quantity of contents of the multi- whole units with any remainder in unit package in terms of avoirdupois or terms of fluid ounces or common or fluid ounces, except that such declara- decimal fraction of the pint or quart. tion of total quantity need not be fol- For example, a declaration of three- lowed by an additional parenthetical

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declaration in terms of the largest requirements of this paragraph if they whole units and subdivisions thereof, are in a shipping container and the as otherwise required by this para- statement of net quantity of contents graph (c). ‘‘A multiunit retail package’’ on the shipping container meets the re- is a package containing two or more quirements of paragraph (c)(6) of this individually packaged units of the section; identical commodity and in the same (iii) Individually wrapped and labeled quantity, with the individual packages packages of less than 1⁄2 ounce net intended to be sold as part of the mul- weight bearing labels declaring net tiunit retail package but capable of weight, price per pound, and total being sold individually. Open multiunit price, shall be exempt from the type retail packages that do not obscure the size, dual declaration, and placement number of units and the labeling there- requirements of this paragraph if an on are not subject to this paragraph (c) accurate statement of net weight is (8) if the labeling of each individual shown conspicuously on the principal unit complies with the requirements of display panel of the package. this paragraph (c). (10) As used in this section a ‘‘ran- (9) The following exemptions from dom weight consumer size package’’ is the requirements contained in this sec- one of a lot, shipment or delivery of tion are hereby established: packages of the same product, with (i) Individually wrapped, random varying weights and with no fixed weight consumer size packages of poul- weight pattern. try products (as specified in paragraph [37 FR 9706, May 16, 1972, as amended at 39 (c)(10) of this section) and poultry prod- FR 4569, Feb. 5, 1974; 53 FR 28635, July 29, ucts that are subject to shrinkage 1988; 55 FR 49835, Nov. 30, 1990] through moisture loss during good distribution practices and are designated § 381.121a Quantity of contents label- as gray area type of products as defined ing. in NBS handbook 133, section 3.18.2, Sections 381.121a through 381.121e of need not bear a net weight statement this part prescribe the procedures to be when shipped from an official estab- followed for determining net weight lishment provided a net weight ship- compliance and prescribe the reason- ping statement which meets the re- able variations from the declared net quirements of paragraph (c)(6) of this weight on the labels of immediate con- section is applied to the shipping containers of products in accordance with tainer prior to shipping it from the of- § 381.121 of this part. ficial establishment. Net weight state- [55 FR 49835, Nov. 30, 1990] ments so applied to the shipping container are exempt from the type size, § 381.121b Definitions and procedures dual declaration, and placement re- for determining net weight compli- quirements of this paragraph if an ac- ance. curate statement of net weight is (a) For the purpose of § 381.121b of shown conspicuously on the principal this part, the reasonable variations al- display panel of the shipping container. lowed, definitions, and procedures to be The net weight also shall be applied di- used in determining net weight and net rectly to random weight consumer size weight compliance are described in the packages prior to retail display and National Institute of Standards and sale. The net weight statement of ran- Technology (NIST) Handbook 133, dom weight consumer size packages for ‘‘Checking the Net Contents of retail sale shall be exempt from the Packaged Goods,’’ Third Edition, Sep- type size, dual declaration, and place- tember 1988, and Supplements 1, 2, 3, ment requirements of this paragraph if and 4 dated September 1990, October an accurate statement of net weight is 1991, October 1992, and October 1994, re- shown conspicuously on the principal spectively, which are incorporated by display panel of the package. reference, with the exception of the (ii) Individually wrapped and labeled NIST Handbook 133 and Supplements 1 packages of less than 1⁄2 ounce net and 3 requirements listed in paragraphs weight and random weight consumer (b) and (c) of this section. Those provi- size packages shall be exempt from the sions, incorporated by reference herein,

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are considered mandatory require- Supplement 4 dated October 1994, of ments. This incorporation was ap- NIST Handbook 133 are not incor- proved by the Director of the Federal porated by reference. Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. (These mate- Supplement 1 rials are incorporated as they exist on Chapter 2 General Considerations the date of approval.) Copies may be purchased from the Superintendent of 2.13.1. Polyethylene Sheeting and Film Documents, U.S. Government Printing 2.13.2. Textiles Office, Washington, DC 20402. It is also 2.13.3. Mulch available for inspection at the Office of Chapter 3 Methods of Test for Packages the Federal Register Information Cen- Labeled by Weight ter, 800 North Capitol Street NW., suite 3.11.4. Exhausting the Aerosol Container 700, Washington, DC 20408. (b) The following NBS Handbook 133 Chapter 4 Methods of Test for Packages requirements are not incorporated by Labeled by Volume reference. 4.6.4. Method D: Determining the Net Con- Chapter 2—General Considerations tents of Compressed Gas in Cylinders 4.7. Milk 2.13.1 Polyethylene Sheeting and Film 4.16. Fresh Oysters Labeled by Volume 2.13.2 Textiles 2.13.3 Mulch Chapter 5 Methods of Test for Packages La- beled by Count, Length, Area, Thickness, Chapter 3—Methods of Test for Packages or Combinations of Quantities Labeled by Weight 5.4. Polyethylene Sheeting 3.11. Aerosol Packages 3.14. Glazed Raw Seafood and Fish Supplement 3 3.15. Canned Coffee 3.16. Borax Chapter 3 Methods of Test for Packages 3.17. Flour Labeled by Weight Chapter 4—Methods of Test for Packages 3.17. Flour and Dry Pet Food Labeled by Volume Chapter 5 Methods of Test for Packages La- 4.7. Milk beled by Count, Length, Area, Thickness, 4.8. Mayonnaise and Salad Dressing or Combinations of Quantities 4.9. Paint, Varnish, and Lacquers—Nonaero- sol 5.4. Polyethylene Sheeting 4.11. Peat Moss 5.5. Paper Plates 4.12. Bark Mulch 65.8. Baler Twine 4.15. Ice Cream Novelties Appendix A. Forms and Worksheets Chapter 5—Methods of Test for Packages La- beled by Count, Length, Area, Thickness, Supplement 4 or Combinations of Quantities 3.11 Aerosol Packages 5.4. Polyethlene Sheeting 3.11.1 Equipment 5.5. Paper Plates 3.11.2 Preparation for Test 5.6. Sanitary Paper Products 3.11.3 The Determination of Net Contents: 5.7. Pressed and Blown Glass Tumblers and Part 1 Stemware 3.11.4 Exhausting the Aerosol Container Appendix D: Package Net Contents 3.11.5 The Determination of Net Contents: Regulations Part 2 D.1.1 U.S. Department of Health and Human [55 FR 49835, Nov. 30, 1990, as amended at 60 Servcies, Food and Drug Administration FR 12885, Mar. 9, 1995] D.1.2 U.S. Department of Agriculture, Food Safety and Inspection Servcie § 381.121c Scale requirements for accu- D.1.3 Federal Trade Commission rate weights, repairs, adjustments, D.1.4 Environmental Protection Agency and replacement after inspection. D.1.5 U.S. Department of the Treasury, Bu- (a) All scales used to weight poultry reau of Alcohol, Tobacco, and Firearms products sold or otherwise distributed (c) The following requirements of in commerce in federally inspected Supplement 1 dated September 1990, poultry plants shall be installed, main- Supplement 3 dated October 1992, and tained, and operated to insure accurate

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weights. Such scales shall meet the ap- tested for accuracy in accordance with plicable requirements contained in Na- the technical requirements of NIST tional Institute of Standards and Tech- Handbook 44, at least once during the nology (NIST) Handbook 44, ‘‘Speci- calendar year. In cases where the fications, Tolerances and Other Tech- scales are found not to maintain accu- nical Requirements for Weighing and racy between tests, more fequent tests Measuring Devices,’’ 1994 Edition, Oc- may be required and monitored by an tober 1993, which is incorporated by authorized USDA program official. reference. This incorporation was ap- (b) The operator of each official es- proved by the Director of the Federal tablishment shall display on or near Register in accordance with 5 U.S.C. each scale a valid certification of the 552(a) and 1 CFR part 51. (These mate- scale’s accuracy from a State or local rials are incorporated as they exist on government’s weights and measures the date of approval.) A notice of any authority or from a State registered or change in the Handbook cited herein licensed scale repair firm or person, or will be published in the FEDERAL REG- shall have an FSIS approval net weight ISTER. Copies may be purchased from program under a Total Quality Control the Superintendent of Documents, U.S. System or Partial Quality Control Pro- Government Printing Office, Washing- gram in accordance with § 381.145 of ton, DC 20402. It is also available for in- this subchapter. spection at the Office of the Federal Register Information Center, 800 North [55 FR 49836, Nov. 30, 1990] Capitol Street NW., suite 700, Washing- § 381.121e Handling of failed product. ton, DC 20408. (b) All scales used to weigh poultry Any lot of product which is found to products sold or otherwise distributed be out of compliance with net weight in commerce or in State designated requirements upon testing in accord- under section 5(c) of the Poultry Prod- ance with § 381.121b of this subchapter ucts Inspection Act, shall be of suffi- shall be handled as follows: cient capacity to weigh the entire unit (a) A lot tested in an official estab- and/or package. lishment and found not to comply with (c) No scale shall be used at a feder- net weight requirements may be re- ally inspected establishment to weigh processed and must be reweighed and poultry products unless it has been remarked to satisfy the net weight re- found upon test and inspection as spec- quirements of this section, and be rein- ified in NIST Handbook 44 to provide spected in accordance with the require- accurate weight. If a scale is inspected ments of this part. or tested and found to be inaccurate, or (b) A lot tested outside of an official if any repairs, adjustments or replace- establishment and found not to comply ments are made to a scale, it shall not with net weight requirements must be be used until it has been reinspected reweighed and remarked with a proper and retested by a USDA official, or a net weight statement, provided that State or local government weights and such reweighing and remarking shall measures official, or a State registered not deface, cover, or destroy any other or licensed scale repair firm or person, marking or labeling required under and it must meet all accuracy require- this subchapter and the net quantity of ments as specified in NIST Handbook contents is shown with the same prom- 44. If a USDA inspector has put a ‘‘Re- inence as the most conspicuous feature tain’’ tag on a scale it can only be re- of a label. moved by a USDA inspector. As long as [55 FR 49836, Nov. 30, 1990] the tag is on the scale, it shall not be used. § 381.122 Identification of manufac- [55 FR 49836, Nov. 30, 1990, as amended at 60 turer, packer or distributor. FR 12885, Mar. 9, 1995] The name and address, including zip code, of the manufacturer, packer, or § 381.121d Scales; testing of. distributor shall be shown on the label (a) The operator of each official es- and if only the name and address of the tablishment that weighs poultry food distributor is shown, it shall be quali- products shall cause such scales to be fied by such term as ‘‘packed for,’’

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‘‘distributed by,’’ or ‘‘distributors.’’ the claim for such use is based in whole The name and place of business of the or in part and shall be in conformity manufacturer, packer, or distributor with regulations (21 CFR part 125) es- may be shown on the principal display tablished pursuant to sections 403 and panel, on the 20-percent panel of the 701 of the Federal Food, Drug, and Cos- principal display panel reserved for re- metic Act (21 U.S.C. 343, 371). quired information, on the front riser panel of frozen food cartons, or on the § 381.125 Special handling label re- information panel. quirements. (a) Packaged products which require [37 FR 9706, May 16, 1972, as amended at 59 FR 40215, Aug. 8, 1994] special handling to maintain their wholesome condition shall have promi- § 381.123 Official inspection mark; offi- nently displayed on the principal dis- cial establishment number. play panel of the label the statement: The immediate container of every in- ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ spected and passed poultry product ‘‘Keep Refrigerated or Frozen,’’ ‘‘Per- shall bear: ishable—Keep Under Refrigeration,’’ or (a) The official inspection legend; and such similar statement as the Adminis- (b) The official establishment num- trator may approve in specific cases. ber of the official establishment in The immediate containers for products which the product was processed under that are frozen during distribution and inspection and placed as follows: intended to be thawed prior to or dur- (1) Within the official inspection leg- ing display for sale shall bear the end in the form required by Subpart M statement ‘‘Shipped/Stored and Han- of this part; or dled Frozen for Your Protection, Keep (2) Outside the official inspection leg- Refrigerated or Freeze.’’ For all canned end elsewhere on the exterior of the perishable products, the statement container or its labeling, e.g., the lid of shall be shown in upper case letters a can, if shown in a prominent and leg- one-fourth inch in height for contain- ible manner in a size sufficient to in- ers having a net weight of 3 pounds or sure easy visibility and recognition and less, and for containers having a net accompanied by the prefix ‘‘P’’; or weight over 3 pounds, the statement (3) Off the exterior of the container, shall be shown in letters one-half inch e.g., on a metal clip used to close cas- in height. ings or bags, or on the back of a paper (b) Safe handling instructions shall label of a canned product, or on other be provided for all poultry products not packaging or labeling in the container, heat processed in accordance with the e.g., on aluminum pans and trays provisions of § 381.150(b) or that have placed within containers, when a state- not undergone other further processing ment of its location is printed contig- that would render them ready-to-eat, uous to the official inspection legend, except as exempted under paragraph such as ‘‘Plant No. on Package Clo- (b)(4) of this section. sure’’ or ‘‘Plant No. on Pan’’, if shown (1) (i) Safe handling instructions in a prominent and legible manner in a shall accompany the poultry products, size sufficient to ensure easy visibility specified in this paragraph (b), destined and recognition; or for household consumers, hotels, res- (4) On an insert label placed under a taurants, or similar institutions and transparent covering if clearly visible shall appear on the label. The informa- and legible and accompanied by the tion shall be in lettering no smaller prefix ‘‘P’’. than one-sixteenth of an inch in size and shall be prominently placed with [47 FR 29515, July 7, 1982] such conspicuousness (as compared with other words, statements, designs § 381.124 Dietary food claims. or devices in the labeling) as to render If a product purports to be or is rep- it likely to be read and understood by resented for any special dietary use by the ordinary individual under cus- man, its label shall bear a statement tomary conditions of purchase and use. concerning its vitamin, mineral, and (ii) The safe handling information other dietary properties upon which shall be presented on the label under

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the heading ‘‘Safe Handling Instruc- shall be displayed next to the state- tions’’ which shall be set in type size ment.); larger than the print size of the ration- (iii) Cook thoroughly. (A graphic il- ale statement and handling statements lustration of a skillet shall be dis- as discussed in paragraphs (b)(2) and played next to the statement.); and (b)(3) of this section. The safe handling (iv) Keep hot foods hot. Refrigerate information shall be set off by a border leftovers immediately or discard. (A and shall be one color type printed on graphic illustration of a thermometer a single color contrasting background shall be displayed next to the state- whenever practical. ment.) (2) (i) The labels of the poultry prod- (4) Poultry products intended for fur- ucts, specified in this paragraph (b) and ther processing at another official es- prepared from inspected and passed tablishment are exempt from the re- poultry, shall include the following ra- quirements prescribed in paragraphs tionale statement as part of the safe (b)(1) through (b)(3) of this section. handling instructions, ‘‘This product [37 FR 9706, May 16, 1972, as amended at 39 was prepared from inspected and passed FR 4569, Feb. 5, 1974; 59 FR 14540, Mar. 28, meat and/or poultry. Some food prod- 1994] ucts may contain bacteria that could cause illness if the product is mis- § 381.126 Date of packing and date of handled or cooked improperly. For processing; contents of cans. your protection, follow these safe han- (a) Either the immediate container dling instructions.’’ This statement or the shipping container of all poultry shall be placed immediately after the food products shall be plainly and per- heading and before the safe handling manently marked by code or otherwise statements. with the date of packing. If calendar (ii) The labels of the poultry prod- dating is used, it must be accompanied ucts, specified in this paragraph (b) and by an explanatory statement, as pro- prepared pursuant to § 381.10(a) (2), (5), vided in § 381.129(c)(2). (6), and (7), shall include the following (b) The immediate container for rationale statement as part of the safe dressed poultry shall be marked with a handling instructions, ‘‘Some food lot number which shall be the number products may contain bacteria that of the day of the year on which the could cause illness if the product is poultry was slaughtered or a coded mishandled or cooked improperly. For number. your protection, follow these safe han- (c) All canned products shall be dling instructions.’’ This statement plainly and permanently marked, by shall be placed immediately after the code or otherwise, on the containers, heading and before the safe handling with the identity of the contents and statements. date of canning, except that canned (3) Poultry products, specified in this products packed in glass containers are paragraph (b), shall bear the labeling not required to be marked with the statements. date of canning if such information ap- (i) Keep refrigerated or frozen. Thaw pears on the shipping container. If cal- in refrigerator or microwave. (Any por- endar dating is used, it must be accom- tion of this statement that is in con- panied by an explanatory statement, as flict with the product’s specific han- provided in § 381.129(c)(2). dling instructions may be omitted, e.g., (d) If any marking is by code, the in- instructions to cook without thawing.) spector in charge shall be informed as (A graphic illustration of a refrigerator to its meaning. shall be displayed next to the state- [37 FR 9706, May 16, 1972, as amended at 39 ment.); FR 28516, Aug. 8, 1974; 39 FR 35784, Oct. 4, (ii) Keep raw meat and poultry sepa- 1974] rate from other foods. Wash working surfaces (including cutting boards), § 381.127 Wording on labels of ship- utensils, and hands after touching raw ping containers. meat or poultry. (A graphic illustra- (a) Each label for use on a shipping tion of soapy hands under a faucet container for inspected and passed

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poultry products shall bear, in dis- ity, shall appear on any label. For ex- tinctly legible form, the following in- ample: formation: (1) Official grade designations such as (1) The official inspection legend. the letter grades A, B, and C may be (2) The official establishment number used in labeling individual carcasses of of the official establishment in which poultry or containers of poultry prod- the poultry product was inspected, ei- ucts only if such articles have been ther within the official inspection graded by a licensed grader of the Fed- mark, or elsewhere on the container eral or Federal-State poultry grading clearly visible and in proximity to the service and found to qualify for the in- official inspection mark. dicated grade. (2) Terms having geographical sig- § 381.128 Labels in foreign languages. nificance with reference to a particular Any label to be affixed to a container locality may be used only when the of any dressed poultry or other poultry product was produced in that locality. product for foreign commerce may be (3) ‘‘Fresh frozen’’, ‘‘quick frozen’’, printed in a foreign language. However, ‘‘frozen fresh’’, and terms of similar the official inspection legend and es- import apply only to ready-to-cook tablishment number shall appear on poultry processed in accordance with the label in English, but in addition, § 381.66(f)(1). Ready-to-cook poultry may be literally translated into such handled in any other manner and foreign language. Each such label shall dressed poultry may be labeled ‘‘fro- be subject to the applicable provisions zen’’ only if it is frozen in accordance of §§ 381.115 to 381.141, inclusive. Devi- with § 381.66(f)(2) under Department su- ations from the form of labeling re- pervision and is in fact in a frozen quired under the regulations may be state. ‘‘Individually quick frozen approved by the Administrator in spe- (Kind)’’ and terms of similar import cific cases and such modified labeling are applicable only to poultry products may be used for poultry products to be that are frozen as stated on the label exported: Provided, (a) That the pro- and whose component parts can be eas- posed labeling accords to the specifica- ily separated at time of packing. tions of the foreign purchaser, (b) that (4) Poultry products labeled with a it is not in conflict with the Act or the term quoted in any paragraph of laws of the country to which it is in- § 381.170(b) shall comply with the speci- tended for export, and (c) that the out- fications in the applicable paragraph. side of the shipping container is la- However, parts of poultry may be cut beled to show that it is intended for ex- in any manner the processor desires as port; but if such product is sold or of- long as the labeling appropriately re- fered for sale in domestic commerce, flects the contents of the container of all the requirements of the regulations such poultry. shall apply. (5) The terms ‘‘All,’’ ‘‘Pure,’’ ‘‘100%,’’ and terms of similar connotation shall § 381.129 False or misleading labeling not be used on labels for products to or containers. identify ingredient content, unless the (a) No poultry product subject to the product is prepared solely from a single Act shall have any false or misleading ingredient. labeling or any container that is so (6)(i) Raw poultry product whose in- made, formed, or filled as to be mis- ternal temperature has ever been below leading. However, established trade 26 °F, but above 0 °F, may not bear a names and other labeling and contain- label declaration of ‘‘fresh’’ and must ers which are not false or misleading be labeled with the descriptive term and which are approved by the Admin- ‘‘hard chilled.’’ The word ‘‘previously’’ istrator in the regulations or in spe- may be used contiguous to the term cific cases are permitted. ‘‘hard chilled’’ on an optional basis. (b) No statement, word, picture, de- The descriptive term shall be promi- sign, or device which is false or mis- nently displayed on the principal dis- leading in any particular or conveys play panel of the label. If additional la- any false impression or gives any false beling containing the descriptive term indication of origin, identity, or qual- is affixed to the label, it shall be

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prominently affixed thereon with such individual under customary conditions conspicuousness (as compared with of purchase and use. other words, statements, designs or de- (iv) Handling and relabeling of prod- vices in the labeling) as to render it ucts. (A) Except as provided under likely to be read and understood by the paragraph (b)(6)(iii)(C) of this section, ordinary individual under customary when any inspected and passed product conditions of purchase and use. Prod- has become misbranded under this sub- uct as described in this paragraph is part after it has been transported from not subject to the freezing procedures an official establishment, such product required in § 381.66(f)(2) of this sub- may be transported in commerce to an chapter. official establishment after oral per- (ii) Raw poultry product whose inter- mission is obtained from the Area Su- nal temperature has ever been at or pervisor of the area in which that offi- ° below 0 F may not bear a label dec- cial establishment is located. The laration of ‘‘fresh’’ and must be labeled transportation of the product may be with the descriptive term ‘‘frozen’’ ex- to the official establishment from cept when such labeling duplicates or which it had been transported or to an- conflicts with the labeling require- other official establishment designated ments in § 381.125 of this subchapter. by the person desiring to handle the The word ‘‘previously’’ may be used product. The transportation shall be contiguous to the term ‘‘frozen’’ on an authorized only for the purpose of the optional basis. The descriptive term relabeling of the product. The Area Su- shall be prominently displayed on the pervisor shall record the authorization principal display panel of the label. If and other information necessary to additional labeling containing the de- identify the product and shall provide a scriptive term is affixed to the label, it copy of the record to the inspector at shall be prominently affixed thereon the establishment receiving the prod- with such conspicuousness (as com- uct. The shipper shall be furnished a pared with other words, statements, copy of the authorization record upon designs or devices in the labeling) as to request. render it likely to be read and understood by the ordinary individual under (B) Upon the arrival of the shipment customary conditions of purchase and at the official establishment, a careful use. Product as described in this para- inspection shall be made of the product graph is subject to the freezing proce- by the inspector, and if it is found that dures required in § 381.66(f)(2) of this the product is not adulterated, it may subchapter. be received into the establishment; but (iii) Raw poultry product whose in- if the product is found to be adulter- ternal temperature has ever been below ated, it shall at once be condemned and 26°F, but is above 0°F, is not required disposed of in accordance with § 381.95 to bear any specific descriptive term. of this subchapter. Wholesome product Raw poultry product whose internal will be relabeled in accordance with temperature has ever been below 26°F, paragraph (b)(6) (i) or (ii) of this sec- but is above 0°F, may bear labeling tion, as appropriate. with an optional, descriptive term, pro- (C) When any inspected and passed vided the optional, descriptive term product has become misbranded under does not cause the raw poultry product this subpart after it has been trans- to become misbranded. If used, an op- ported from an official establishment, tional, descriptive term must be promi- the owner may transport the product nently displayed on the principal dis- in commerce to a retail entity for re- play panel of the label. If additional la- labeling in accordance with paragraph beling containing the optional, descrip- (b)(6) (i) or (ii) of this section, as appro- tive term is affixed to the label, it priate, or to other end users, such as must be prominently affixed on the hotels, restaurants or similar institu- label. The additional labeling must be tions; or, relabel the product in accord- so conspicuous (as compared with other ance with paragraph (b)(6) (i) or (ii) of words, statements, designs, or devices this section, as appropriate if the prod- in the labeling) that it is likely to be uct is already at a retail entity. A read and understood by the ordinary hotel, restaurant or similar institution

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is not required to relabel product mis- EFFECTIVE DATE NOTE: At 61 FR 66200, Dec. branded under this subpart; Provided, 17, 1996, § 381.129 was amended by revising That the product is prepared in meals paragraphs (b)(6)(i) and (ii); by redesignating or as entrees only for sale or service di- paragraph (b)(6)(iii) as (b)(6)(iv); and by add- rectly to individual consumers at such ing a new paragraph (b)(6)(iii), effective Dec. 17, 1997. For the convenience of the user, the institutions, and that the mark of in- revised text is set forth as follows: spection is removed or obliterated. Oral permission shall be obtained from § 381.129 False or misleading labeling or the Area Officer-in-Charge of the Com- containers. pliance Program for the area in which the product is located prior to such * * * * * transportation or relabeling. The Area Officer-in-Charge shall record the au- (b) * * * thorization and other information nec- (6)(i) Raw poultry product whose internal ° essary to identify the product, and temperature has ever been below 26 F may not bear a label declaration of ‘‘fresh.’’ Raw shall furnish a copy of the authoriza- poultry product bearing a label declaration tion record upon request. Before being of ‘‘fresh’’ but whose internal temperature offered for sale at a retail entity, such has ever been below 26°F is mislabeled. The product shall be relabeled. ‘‘fresh’’ designation may be deleted from (c) A calendar date may be shown on such product in accordance with labeling when declared in accordance § 381.133(b)(9)(xxiv). The temperature of indi- with the provisions of this paragraph: vidual packages of raw poultry product with- (1) The calendar date shall express in an official establishment may deviate ° ° the month of the year and the day of below the 26 F standard by 1 (i.e., have a ° the month for all products and also the temperature of 25 F) and still be labeled ‘‘fresh.’’ The temperature of individual pack- year in the case of products hermeti- ages of raw poultry product outside an offi- cally sealed in metal or glass contain- cial establishment may deviate below the ers, dried or frozen products, or any 26°F standard by 2° (i.e., have a temperature other products that the Administrator of 24°F) and still be labeled ‘‘fresh.’’ The av- finds should be labeled with the year erage temperature of poultry product lots of because the distribution and marketing each specific product type must be 26°F. practices with respect to such products Product described in this paragraph is not may cause a label without a year iden- subject to the freezing procedures required in tification to be misleading. § 381.66(f)(2) of this subchapter. (2) Immediately adjacent to the cal- (ii) Raw poultry product whose internal ° endar date shall be a phrase explaining temperature has ever been at or below 0 F the meaning of such date in terms of must be labeled with the descriptive term ‘‘frozen,’’ except when such labeling dupli- ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use cates or conflicts with the labeling require- before’’ date, with or without a further ments in § 381.125 of this subchapter. The qualifying phrase, e.g., ‘‘For Maximum word ‘‘previously’’ may be placed next to the Freshness’’ or ‘‘For Best Quality’’, and term ‘‘frozen’’ on an optional basis. The de- such phrases shall be approved by the scriptive term must be prominently dis- Administrator as prescribed in § 381.132. played on the principal display panel of the (d) When sodium alginate, calcium label. If additional labeling containing the carbonate, lactic acid, and calcium lac- descriptive term is affixed to the label, it tate are used together in a dry binding must be prominently affixed to the label. matrix in ground and formed poultry The additional labeling must be so conspicu- products, as permitted in § 381.147 of ous (as compared with other words, statements, designs, or devices in the labeling) this subchapter, there shall appear on that it is likely to be read and understood by the label contiguous to the product the ordinary individual under customary name, a statement to indicate the use conditions of purchase and use. Product de- of sodium alginate, calcium carbonate, scribed in this paragraph is subject to the lactic acid, and calcium lactate. freezing procedures required in § 381.66(f)(2) of this subchapter. [37 FR 9706, May 16, 1972, as amended at 39 FR 28516, Aug. 8, 1974; 39 FR 42339, Dec. 5, 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, * * * * * Aug. 25, 1995; 61 FR 66200, Dec. 17, 1996; 61 FR 68821, Dec. 30, 1996]

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§ 381.130 False or misleading labeling chapter, without further approval by or containers; orders to withhold the Administrator. The provisions of from use. this paragraph do not apply to marking If the Administrator has reason to devices containing the official inspec- believe that any marking or other lation legend shown in Figure 5 of beling or the size or form of any con- § 381.102. tainer in use or proposed for use with (b) No brand manufacturer or other respect to any article subject to the person shall cast or otherwise make, Act is false or misleading in any par- without an official certificate issued in ticular, he may direct that the use of quadruplicate by a Program employee, the article be withheld unless it is a marking device containing the offi- modified in such manner as the Admin- cial inspection legend shown in Figure istrator may prescribe so that it will 5 of § 381.102 or any simulation of that not be false or misleading. If the person legend. using or proposing to use the labeling (1) The certificate is a Food Safety or container does not accept the deter- and Inspection Service form for signa- mination of the Administrator, he may ture by a Program employee and the request a hearing, but the use of the la- official establishment ordering the marking device, bearing a certificate beling or container shall, if the Admin- serial number and a letterhead and the istrator so directs, be withheld pending seal of the United States Department hearing and final determination by the of Agriculture. The certificate author- Secretary in accordance with applica- izes the making of only the devices of ble rules of practice. Any such deter- the type and quantity listed on the cer- mination with respect to the matter by tificate. the Secretary shall be conclusive un- (2) After signing the certificate, the less, within 30 days after the receipt of Program employee and the establish- notice of such final determination, the ment shall each keep a copy, and the person adversely affected thereby ap- remaining two copies shall be given to peals to the U.S. Court of Appeals for the marking device manufacturer. the Circuit in which he has his prin- (3) The manufacturer of the marking cipal place of business, or to the U.S. devices shall engrave or otherwise Court of Appeals for the District of Co- mark each marking device with a per- lumbia Circuit. The provisions of sec- manent identifying serial number tion 204 of the Packers and Stockyards unique to it. The manufacturer shall Act of 1921, as amended, shall be appli- list on each of the two copies of the cable to appeals taken under this sec- certificate given to the manufacturer tion. the number of each marking device au- § 381.131 Preparation of labeling or thorized by the certificate. The manu- other devices bearing official in- facturer shall retain one copy of the spection marks without advance ap- certificate for the manufacturer’s proval prohibited; exceptions. records and return the remaining copy (a) Except for the purposes of prepar- with the marking devices to the Pro- ing and submitting a sample or sam- gram employee whose name and ad- ples of the same to the Administrator dress are given on the certificate as the for approval, no brand manufacturer, recipient. printer, or other person shall cast, (4) In order that all such marking de- print, lithograph, or otherwise make vices bear identifying numbers, within any marking device containing any of- one year after June 24, 1985, an estab- ficial mark or simulation thereof, or lishment shall either replace each such any label bearing any such mark or marking device that does not bear an simulation, without the written au- identifying number, or, under the di- thority therefor of the Administrator. rection of the inspector-in-charge, However, when any such sample label, mark such marking device with a per- or other marking device, is approved manent identifying number. by the Administrator, additional sup- (Recordkeeping requirements approved by plies of the approved label, or marking the Office of Management and Budget under device, may be made for use in accord- control number 0583–0015) ance with the regulations in this sub- [50 FR 21423, May 24, 1985]

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§ 381.132 Labeling approval. (e) Inserts, tags, liners, pasters, and (a) No final labeling shall be used on like devices containing printed or any product unless the sketch labeling graphic matter and for use on, or to be of such final labeling has been submit- placed within, containers and coverings ted for approval to the Food Labeling of product shall be submitted for ap- Division, Regulatory Programs, Food proval in the same manner as provided Safety and Inspection Service, and ap- for labeling in § 381.132(a), except that proved by such division, accompanied such devices which contain no ref- by FSIS Form, Application for Ap- erence to product and bear no mislead- proval of Labels, Marking, and Devices, ing feature shall be used without sub- except for generically approved label- mission for approval as prescribed in ing authorized for use in § 381.133(b) (2)– § 381.133(b)(9). (9). The management of the official es- (f)(1) Consistent with the require- tablishment or establishment certified ments of this section, temporary ap- under a foreign inspection system, in proval for the use of a final label or accordance with subpart T of this part, other final labeling that may otherwise must maintain a copy of all labeling be deemed deficient in some particular used, along with the product formula- may be granted by the Food Labeling tion and processing procedure, in ac- Division. Temporary approvals may be cordance with subpart Q of this part. granted for a period not to exceed 180 Such records shall be made available to calendar days under the following con- any duly authorized representative of ditions: the Secretary upon request. (i) The proposed labeling would not (b) The Food Labeling Division shall misrepresent the product; permit submission for approval of only (ii) The use of the labeling would not sketch labeling, as defined in present any potential health, safety, or § 381.132(d), for all products, except as dietary problems to the consumer; provided in § 381.133(b) (2)–(9) and except (iii) Denial of the request would cre- for temporary use of final labeling as ate undue economic hardship; and prescribed in paragraph (f) of this sec- (iv) An unfair competitive advantage tion. would not result from the granting of (c) All labeling required to be sub- the temporary approval. mitted for approval as set forth in (2) Extensions of temporary approv- § 381.132(b) shall be submitted in dupli- als may also be granted by the Food cate to the Food Labeling Division, Labeling Division, provided that the Regulatory Programs, Food Safety and applicant demonstrates that new cir- Inspection Service, U.S. Department of cumstances, meeting the above cri- Agriculture, Washington, DC 20250. A teria, have developed since the original parent company for a corporation may temporary approval was granted. submit only one labeling application (in duplicate) for a product produced in [60 FR 67456, Dec. 29, 1995] other establishments that are owned by the corporation. § 381.133 Generically approved label- (d) ‘‘Sketch’’ labeling is a printer’s ing. proof or equivalent which clearly (a)(1) An official establishment or an shows all labeling features, size, loca- establishment certified under a foreign tion, and indication of final color, as inspection system, in accordance with specified in subpart N of this part. subpart T of this part, is authorized to FSIS will accept sketches that are use generically approved labeling, as hand drawn, computer generated or defined in paragraph (b) of this section, other reasonable facsimiles that clear- without such labeling being submitted ly reflect and project the final version for approval to the Food Safety and In- of the labeling. Indication of final color spection Service in Washington or the may be met by: submission of a color field, provided the labeling is in accord sketch, submission of a sketch which with this section and shows all manda- indicates by descriptive language the tory features in a prominent manner as final colors, or submission with the required in subpart N of this part, and sketch of previously approved final la- is not otherwise false or misleading in beling that indicates the final colors. any particular.

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(2) The Food Safety and Inspection placed within containers, and coverings Service shall select samples of generi- of products, provided such devices con- cally approved labeling from the tain no reference to product and bear records maintained by official estab- no misleading feature; lishments and establishments certified (8) Labeling for consumer test prod- under foreign inspection systems, in ucts not intended for sale; and accordance with subpart T of this part, (9) Labeling which was previously ap- as required in § 381.132, to determine proved by the Food Labeling Division compliance with labeling require- as sketch labeling, and the final label- ments. Any finding of false or misleading was prepared without modification ing labeling shall institute the pro- or with the following modifications: ceedings prescribed in § 381.233. (i) All features of the labeling are (b) Generically approved labeling is proportionately enlarged or reduced, labeling which complies with the fol- provided that all minimum size re- lowing: quirements specified in applicable reg- (1) Labeling for a product which has ulations are met and the labeling is a product standard as specified in sub- legible; part 381 of this subchapter or the (ii) The substitution of any unit of Standards and Labeling Policy Book measurement with its abbreviation or and which does not contain any special the substitution of any abbreviation claims, such as quality claims, nutri- with its unit of measurement, e.g., ent content claims, health claims, neg- ‘‘lb.’’ for ‘‘pound,’’ or ‘‘oz.’’ for ative claims, geographical origin ‘‘ounce,’’ or of the word ‘‘pound’’ for claims, or guarantees, or which is not a ‘‘lb.’’ or ‘‘ounce’’ for ‘‘oz.’’; domestic product labeled in a foreign language; (iii) A master or stock label has been (2) Labeling for single-ingredient approved from which the name and ad- products (such as chicken legs or tur- dress of the distributor are omitted and key breasts) which does not contain such name and address are applied be- any special claims, such as quality fore being used (in such case, the words claims, nutrient content claims, health ‘‘prepared for’’ or similar statement claims, negative claims, geographical must be shown together with the blank origin claims, or guarantees, or which space reserved for the insertion of the is not a domestic product labeled with name and address when such labels are a foreign language; offered for approval); (3) Labeling for containers of prod- (iv) Wrappers or other covers bearing ucts sold under contract specifications pictorial designs, emblematic designs to Federal Government agencies, when or illustrations, e.g., floral arrange- such product is not offered for sale to ments, illustrations of animals, fire- the general public, provided that the works, etc. are used with approved la- contract specifications include specific beling (the use of such designs will not requirements with respect to labeling, make necessary the application of la- and are made available to the inspec- beling not otherwise required); tor-in-charge; (v) A change in the language or the (4) Labeling for shipping containers arrangement of directions pertaining which contain fully labeled immediate to the opening of containers or the containers, provided such labeling serving of the product; complies with § 381.127; (vi) The addition, deletion, or amend- (5) Labeling for products not in- ment of a dated or undated coupon, a tended for human food, provided they cents-off statement, cooking instruc- comply with §§ 381.152(c) and 381.193, tions, packer product code informa- and labeling for poultry heads and feet tion, or UPC product code information; for export for processing as human food (vii) Any change in the name or ad- if they comply with § 381.190(b); dress of the packer, manufacturer or (6) Poultry inspection legends, which distributor that appears in the signa- comply with subpart M of this part; ture line; (7) Inserts, tags, liners, pasters, and (viii) Any change in the net weight, like devices containing printed or provided that the size of the net weight graphic matter and for use on, or to be statement complies with § 381.121;

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(ix) The addition, deletion, or amend- tion maintains its accuracy and con- ment of recipe suggestions for the sistency; product; (xxiv) Deletion of any claim, and the (x) Any change in punctuation; deletion of non-mandatory features or (xi) Newly assigned or revised estab- non-mandatory information; lishment numbers for a particular es- (xxv) The addition or deletion of a di- tablishment for which use of the label- rect translation of the English lan- ing has been approved by the Food La- guage into a foreign language for prod- beling Division, Regulatory Programs; ucts marked ‘‘for export only’’; and (xii) The addition or deletion of open (xxvi) The addition of a descriptive dating information; term as required by § 381.129(b)(6). (xiii) A change in the type of packag- (xxvii) The use of the descriptive ing material on which the label is Term frozen as required by printed; § 381.129(b)(6)(ii) of this subchapter. (xiv) Brand name changes, provided [60 FR 67457, Dec. 29, 1995, as amended at 61 that there are no design changes, the FR 66201, Dec. 17, 1996] brand name does not use a term that connotes quality or other product char- EFFECTIVE DATE NOTE: At 61 FR 66201, Dec. 17, 1996, § 381.133 was amended by revising acteristics, the brand name has no geo- paragraph (b)(9)(xxvi) and adding paragraph graphic significance, and the brand (b)(9)(xxvii), effective Dec. 17, 1997. For the name does not affect the name of the convenience of the user, the revised text is product; set forth as follows: (xv) The deletion of the word ‘‘new’’ on new product labeling; § 381.133 Generically approved labeling. (xvi) The addition, deletion, or amendment of special handling state- * * * * * ments, provided that the change is con- (b) * * * sistent with § 381.125(a); (9) * * * (xvii) The addition of safe handling (xxvi) The use of the descriptive term instructions as required by § 381.125(b); ‘‘fresh’’ in accordance with § 381.129(b)(6)(i) of (xviii) Changes reflecting a change in this subchapter. the quantity of an ingredient shown in the formula without a change in the § 381.134 Requirement of formulas. order of predominance shown on the Copies of each label submitted for ap- label, provided that the change in proval, shall when the Administrator quantity of ingredients complies with requires in any specific case, be accom- any minimum or maximum limits for panied by a statement showing, by the use of such ingredients prescribed their common or usual names, the in § 381.147 and subpart P of this part; kinds and percentages of the ingredi- (xix) Changes in the color of the la- ents comprising the poultry product beling, provided that sufficient con- and by a statement indicating the trast and legibility remain; method or preparation of the product (xx) A change in the product vi- with respect to which the label is to be gnette, provided that the change does used. Approximate percentages may be not affect mandatory labeling informa- given in cases where the percentages of tion or misrepresent the content of the ingredients may vary from time to package; time, if the limits of variation are stat- (xxi) The addition, deletion, or sub- ed. stitution of the official USDA poultry [37 FR 9706, May 16, 1972, as amended at 39 grade shield; (xxii) A change in the es- FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, tablishment number by a corporation 1994. Redesignated at 60 FR 67457, Dec. 29, or parent company for an establish- 1995] ment under its ownership; (xxiii) Changes in nutrition labeling § 381.135 Irradiated poultry product. that only involve quantitative adjust- (a) The labeling of packages of poul- ments to the nutrition labeling infor- try product irradiated in conformance mation, except for services sizes, pro- with § 381.147(f)(4) of this part must vided the nutrition labeling informa- bear the following logo along with a

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statement such as, ‘‘Treated with radi- any such legend shall be filled except ation’’ or ‘‘Treated by irradiation,’’ in under such supervision. addition to all other labeling require- (b) No official inspection legend shall ments of this subpart. The logo must be used on any poultry product or be placed prominently and conspicu- other article which does not qualify for ously in conjunction with the required such mark under the regulations. statement and be colored green. The statement must appear as a qualifier § 381.137 Evidence of labeling and devices approval. contiguous to the product name and in letters of the same style, color, and No inspector shall authorize the use type as the product name. Letters used of any device bearing any official infor the qualifying statement shall be spection legend unless he or she has on no less than one-third the size of the file evidence that such device has been approved in accordance with the provi- largest letter in the product name. Any sions of this subpart. labeling bearing the logo and any wording of explanation with respect to this [60 FR 67458, Dec. 29, 1995] logo must be approved as required by subparts M and N of this part. § 381.138 Unauthorized use or disposition of approved labeling or devices. (a) Labeling and devices approved for use pursuant to § 381.115 shall be used only for the purpose for which approved, and shall not be disposed of from the official establishment for which approved except with written approval of the Administrator. Any unauthorized use or disposition of approved labeling or devices bearing official inspection marks is prohibited and may result in cancellation of the approval. (b) Labeling and containers bearing any official inspection marks, with or without the official establishment (b) The product label must bear the number, may be transported from one handling statement ‘‘Keep Refrig- official establishment to any other of- erated’’ or ‘‘Keep Frozen,’’ as appro- ficial establishment, only if such ship- priate, in conformance with § 381.125 of ments are made with the prior author- this Subpart. ization of the inspector in charge at (c) Optional labeling statements point of origin, who will notify the in- about the purpose for radiation proc- spector in charge at destination con- essing may be included on the product cerning the date of shipment, quantity, label in addition to the above stated re- and type of labeling material involved. quirements. Such statements must not Approved labeling and containers may be false or misleading. be moved without restriction under this part between official establish- [57 FR 43597, Sept. 21, 1992] ments operated by the same person if such labeling and containers are ap- § 381.136 Affixing of official identifica- proved for use at all such establish- tion. ments. No such material shall be used (a) No official inspection legend or at the establishment to which it is any abbreviation or other simulation shipped unless such use conforms with thereof may be affixed to or placed on the requirements of this subpart. or caused to be affixed to or placed on any poultry product or container § 381.139 Removal of official identifica- thereof, except by an inspector or tions. under the supervision of an inspector (a) Every person who receives any or other person authorized by the Ad- poultry product in containers which ministrator, and no container bearing bear any official inspection legend

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shall remove or deface such legend or aging supplier under whose brand name destroy the containers upon removal of and firm name the material is mar- such articles from the containers. keted to the official establishment. (b) No person shall alter, detach, de- The guaranty shall state that the ma- face, or destroy any official identifica- terial’s intended use complies with the tions prescribed in Subpart M that FFDCA and all applicable food additive were applied pursuant to the regula- regulations. The guaranty must iden- tions, unless he is authorized to do so tify the material, e.g., by the distin- by an inspector or this section; and no guishing brand name or code designa- person shall fail to use any such offi- tion appearing on the packaging mate- cial identification when required by rial shipping container; must specify this part. the applicable conditions of use, including temperature limits and other § 381.140 Relabeling poultry products. pertinent limits specified under the When it is claimed by the operator of FFDCA and food additive regulations; an official establishment that some of and must be signed by an authorized its labeled poultry product, which has official of the supplying firm. The been transported to a location other guaranty may be limited to a specific than an official establishment, is in shipment of an article, in which case it need of relabeling because the labeling may be part of or attached to the in- has become mutilated or damaged, or voice covering such shipment, or it for some other reason needs relabeling, may be general and continuing, in the requests for relabeling the poultry which case, in its application to any product shall be sent to the Adminis- article or other shipment of an article, trator and accompanied with a state- it shall be considered to have been ment of the reasons therefor and the given at the date such article was quantity of labeling required. Labeling shipped by the person who gives the material intended for relabeling in- guaranty. Guaranties consistent with spected and passed product shall not be the Food and Drug Administration’s transported from an official establish- regulations regarding such guaranties ment until permission has been re- (21 CFR 7.12 and 7.13) will be accept- ceived from the Administrator. The re- able. The management of the establish- labeling of inspected and passed prod- ment must maintain a file containing uct with official labels shall be done guaranties for all food contact packag- under the supervision of an inspector ing materials in the establishment. pursuant to the regulations in Part 362 The file shall be made available to Pro- of this chapter. The establishment gram inspectors or other Department shall reimburse the Inspection Service officials upon request. While in the of- for any cost involved in supervising the ficial establishment, the identity of all relabeling of such product as provided packaging materials must be traceable in said regulations. to the applicable guaranty. (c) The guaranty by the packaging §§ 381.141–381.143 [Reserved] supplier will be accepted by Program inspectors to establish that the use of § 381.144 Packaging materials. material complies with the FFDCA and (a) Edible products may not be all applicable food additive regula- packaged in a container which is com- tions. posed in whole or in part of any poison- (d) The Department will monitor the ous or deleterious substances which use of packaging materials in official may render the contents adulterated or establishments to assure that the re- injurious to health. All packaging ma- quirements of paragraph (a) of this sec- terials must be safe for the intended tion are met, and may question the use within the meaning of section 409 basis for any guaranty described under of the Federal Food, Drug, and Cos- paragraph (b) of this section. Official metic Act, as amended (FFDCA). establishments and packaging suppli- (b) Packaging materials entering the ers providing written guaranties to official establishment must be accom- those official establishments will be panied or covered by a guaranty, or permitted an opportunity to provide statement of assurance, from the pack- information to designated Department

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officials as needed to verify the basis (g) Nothing in this section shall af- for any such guaranty. The required in- fect the authority of Program inspec- formation will include, but is not lim- tors to refuse a specific material if he/ ited to, manufacturing firm’s name, she determines the material may trade name or code designation for the render products adulterated or injuri- material, complete chemical composi- ous to health. tion, and use. Selection of a material [49 FR 2236, Jan. 19, 1984] for review does not in itself affect a material’s acceptability. Materials may continue to be used during the re- Subpart O—Entry of Articles Into view period. However, if information Official Establishments; Proc- requested from the supplier is not pro- essing Inspection and Other vided within the time indicated in the Reinspections; Processing Re- request—a minimum of 30 days—any quirements applicable guaranty shall cease to be effective and approval to continue § 381.145 Poultry products and other using the specified packaging material articles entering or at official establishments; examination and other in official establishments may be de- requirements. nied. The Administrator may extend this time where reasonable grounds for (a) No poultry product (including extension are shown, as, for example, poultry broth for use in any poultry product in any official establishment) where data must be obtained from sup- may be brought into any official estab- pliers. lishment unless it has been processed (e) The Administrator may dis- in the United States only in an official approve for use in official establish- establishment or imported from a for- ments packaging materials whose use eign country listed in § 381.196(b), and cannot be confirmed as complying with inspected and passed, in accordance the FFDCA and applicable food addi- with the regulations; and unless the tive regulations. Before approval to use container of such product is marked so a packaging material is finally denied as to identify the product as so in- by the Administrator, the affected offi- spected and passed, in accordance with cial establishment and the supplier of § 381.115 or § 381.205, except that poultry the material shall be given notice and products inspected and passed and the opportunity to present their views identified as such under the laws of an to the Administrator. If the official es- ‘‘at least equal’’ State or territory list- tablishment and the supplier do not ac- ed in § 381.187 may be brought into any cept the Administrator’s determina- official establishment solely for stor- tion, a hearing in accordance with ap- age and distribution therefrom without plicable rules of practice will be held to repackaging, relabeling, or processing resolve such dispute. Approval to use in such establishment. No carcass, part the materials pending the outcome of thereof, meat or meat food product of the presentation of views or hearing cattle, sheep, swine, goats, or equines shall be denied if the Administrator de- may be brought into an official estab- termines that such use may present an lishment unless it has been prepared in imminent hazard to public health. the United States only in an official (f) Periodically, the Administrator meat packing establishment, or im- will issue to inspectors a listing, by ported, and inspected and passed, in ac- distinguishing brand name or code des- cordance with the Federal Meat Inspec- ignation, of packaging materials that tion Act, and the regulations under have been reviewed and that fail to such Act (Subchapter A of this chap- meet the requirements of paragraph (a) ter) and is properly marked as so in- of this section. Listed materials will spected and passed; or has been in- not be permitted for use in official es- spected and passed and is identified as tablishments. If a subsequent review of such in accordance with the require- any material indicates that it meets ments of the law and regulations of a the requirements of paragraph (a), the State not designated in § 331.2 of this material will be deleted from the list- chapter; or is present in the official es- ing. tablishment by reason of an exemption

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allowed in the Federal Meat Inspection (c) Applying for Total Plant Quality Act and the regulations under such Act Control. Any owner or operator of an (Subchapter A of this chapter) or the official establishment preparing poul- law and regulations of a State not so try product who has a total plant qual- designated. However, such exempted ity control system or plan for control- articles may enter only under condi- ling such products, after ante-mortem tions approved by the Administrator in and post-mortem inspection, through specific cases, including but not lim- all stages of preparation, may request ited to, complete separation of in- the Administrator to evaluate it to de- spected poultry products and process- termine whether or not that system is ing and other operations with respect adequate to result in product being in thereto from the exempted articles and compliance with the requirements of operations with respect thereto, com- the Act and therefore qualify as a U.S. plete cleanup of facilities and equip- Department of Agriculture (USDA) ment between processing of inspected Total Plant Quality Control Establish- poultry products and the exempted ar- ment. Such a request shall, as a mini- ticles and no commingling of inspected mum, include: and exempted articles in receiving, (1) A letter to the Administrator holding or storage areas. from the establishment owner or opera- (b) All poultry products and all car- tor stating the company’s basis and casses, parts thereof, meat and meat purpose for seeking an approved qual- food products of cattle, sheep, swine, ity control system and willingness to goats, or equines which enter any offi- adhere to the requirements of the sys- cial establishment shall be identified tem as approved by the Department; by the operator of the official estab- that all the establishment’s data, anal- lishment at the time of receipt at the yses, and information generated by its official establishment. All poultry quality control system will be main- products, and all carcasses, parts tained to enable the Department to thereof, meat and meat food products monitor compliance and available to of such animals, which are processed or Department personnel; that plant qual- otherwise handled at any official estab- ity control personnel will have author- lishment shall be subject to examina- ity to halt production or shipping of tion by an inspector at the official es- product in cases where the submitted tablishment in such manner and at quality control systems require it; and such times as may be deemed necessary that the owner or operator (or his/her by the inspector in charge to assure designee) will be available for consulta- compliance with the regulations. Upon tion at any time Department personnel such examination, if any such article consider it necessary. or portion thereof is found to be adul- (2) In the case of an establishment terated, such article or portion shall, having one or more full-time persons in the case of poultry products, be con- whose primary duties are related to the demned and disposed of as prescribed in quality control system, an organiza- § 381.95, unless by reprocessing they tional chart showing that such people may be made not adulterated, and ultimately report to an establishment shall, in the case of such other articles official whose quality control respon- be disposed of according to applicable sibilities are independent of or not pre- law. dominantly production responsibil- Such examination may be accom- ities. In the case of a small establish- plished through use of statistically ment which does not have full-time sound sampling plans that assure a high level of confidence. The inspector products may be obtained from the Circuit in charge shall designate the type of Supervisor. These sampling plans are devel- plan and the program employee shall oped for individual products by the Washing- select the specific plan to be used in ton staff and will be distributed for field use accordance with instructions issued by as they are developed. The type of plan applicable depends on factors such as whether the 1 the Administrator. product is in containers, stage of preparation, and procedures followed by the estab- 1 Further information concerning sampling lishment operator. The specific plan applica- plans which have been adopted for specific ble depends on the kind of product involved.

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quality control personnel, information being in compliance with the require- indicating the nature of the duties and ments of the Act. Such a request shall, responsibilities of the person who will as a minimum, include: also be responsible for the quality con- (1) A letter from the establishment trol system. official responsible for quality control (3) A list identifying those Subparts stating the objective of the program, and sections of the poultry products in- and that all data and information gen- spection regulations which are applica- erated by the program will be main- ble to the operations of the establish- tained to enable the Department to ment applying for approval of a quality monitor compliance and available to control system. This list shall also Department personnel. identify which part of the system will (2) Detailed information concerning serve to maintain compliance with the raw material control, the critical applicable regulations. check or control points, the nature and (4) Detailed information concerning frequency of tests to be made, the the manner in which the system will charts and records that will be used, function. Such information should in- the length of time such charts and clude, but not necessarily be limited records will be maintained in the cus- to, questions of raw material control, tody of the official establishment, the the critical check or control points, limits which will be used and the the nature and frequency of tests to be points at which corrective action will made, the nature of charts and other occur; and the nature of the corrective records that will be used, the length of action—ranging from the least to the time such charts and records will be most severe. maintained in the custody of the offi- (e) Evaluation and Approval of Quality cial establishment, the nature of defi- Control Programs or Systems. (1) The Ad- ciencies the quality control system is ministrator shall evaluate the material designed to identify and control, the presented in accordance with the provi- parameters of limits which will be used sions of paragraph (c) or (d) of this sec- and the points at which corrective action or § 381.149 of this subpart. If it is tion will occur, and the nature of such determined by the Administrator, on corrective action—ranging from the the basis of the evaluation, that the least to most severe: Provided, That total quality control system, partial subsequent to approval of the total quality control program, or quality plant quality control system by the control system for irradiation facilities Administrator, the official establish- will result in finished products con- ment may produce a new product for trolled in this manner being in full test marketing provided labeling for compliance with the requirements of the product has been approved by the the Act and regulation thereunder, the Administrator, the inspector in charge total quality control system, partial has determined that the procedures for quality control program, or quality preparing the product will assure that control system for irradiation facilities all Federal requirements are met, and will be approved and plans will be made the production for test marketing does for implementation under depart- not exceed 6 months. Such new product mental supervision. shall not be produced at that establish- (2) In any situation where the system ment after the 6-month period unless or program is found by the Adminis- approval of the quality control system trator to be unacceptable, formal noti- for that product has been received from fication shall be given to the applicant the Administrator. of the basis for the denial. The appli- (d) Applying for Partial Quality Con- cant will be afforded an opportunity to trol. Any owner or operator of an offi- modify the system or program in ac- cial establishment preparing poultry cordance with this notification. The products who has a quality control pro- applicant shall also be afforded an op- gram for a product, operation, or a part portunity to submit a written state- of an operation, may submit it to the ment in response to this notification of Administrator and request a deter- denial and a right to request a hearing mination as to whether or not that pro- with respect to the merits or validity gram is adequate to result in product of the denial. If the applicant requests

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a hearing and the Administrator, after partial quality control program may be review of the answer, determines the terminated at any time by the owner initial determination to be correct, he or operator of the official establish- shall file with the Hearing Clerk of the ment upon written notice to the Ad- Department the notification, answer ministrator. and the request for hearing, which (2) The approval of a total plant qual- shall constitute the complaint and an- ity control system, partial quality con- swer in the proceeding, which shall trol program, or a quality control sys- thereafter be conducted in accordance tem for irradiation facilities may be with Rules of Practice which shall be terminated upon the establishment’s adopted for this proceeding. receipt of a written notice from the Ad- (3) The establishment owner or oper- ministrator under the following condi- ator shall be responsible for the effec- tions: tive operation of the approved total (i) If adulterated or misbranded poul- plant quality control system, partial try product is found by the quality control program, or quality Adminstrator to have been prepared for control system for irradiation facilities or distributed in commerce by the sub- to assure compliance with the require- ject establishment. In such case, oppor- ments of the Act and regulations there- tunity will be provided to the estab- under. With the exception of a quality lishment owner or operator to present control system for irradiation facili- views to the Administrator within 30 ties, as specified in § 381.149 of this Sub- days of the date of terminating the ap- part, the Secretary shall continue to proval. In those instances where there provide the Federal inspection nec- is a conflict of facts, a hearing, under essary to carry out the responsibilities applicable Rules of Practice, will be af- of the Act. forded to the establishment owner or (f) Labeling Logo. Owners and opera- operator, if requested, to resolve the tors of official establishments having a conflict, The Administrator’s termi- total plant quality control system ap- nation of approval shall remain in ef- proved under the provisions of para- fect pending the final determination of graph (c) of this section, may only use, the proceeding. as a part of any labeling, the following (ii) If the establishment fails to com- logo. Any labeling bearing the logo and ply with the quality control system or any wording of explanation with re- program to which it has agreed after spect to this logo shall be approved as being notified by letter from the Ad- required by subparts M and N of this ministrator or his designee. Prior to part. such termination, opportunity will be provided to the establishment owner or operator to present views to the Adminstrator within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total plant quality control system or partial quality control program has been terminated in accordance with the provisions of this section, an application and request (g) Termination of Quality Control Pro- for approval of the same or a modified grams or Systems. (1) The approval of a total plant quality control system will total plant quality control system or a not be evaluated by the Administrator

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for at least 6 months from the termi- shall, at all times, while they are in nation date, or for at least 2 months such establishment, bear labels show- from the termination date in the case ing the chemical names of the sub- of a partial quality control program. stances in such preparations. In the (4) If approval of a quality control case of preparations containing sub- system for irradiation facilities, as stances which may be used under specified in section 381.149 of this Sub- § 381.147(f)(3) only in limited amounts, part, has been terminated in accord- the container labels shall also show the ance with the provisions of this sec- percentage of each such substance in tion, a request for approval of the same the preparation and shall provide dilu- or a modified quality control system tion directions which prescribe the will be evaluated by the Administrator maximum allowable use concentration upon receipt. of the preparation. (h)(1) Operating Schedule Under Total Plant Quality Control. An official estab- (Recordkeeping requirements approved by lishment with an approved total plant the Office of Management and Budget under control number 0583–0015) quality control system may request approval for an operating schedule of up [37 FR 9706, May 16, 1972, as amended at 45 FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, to 12 consecutive hours per shift. Per- 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. missions will be granted provided that: 11, 1986; 57 FR 43598, Sept. 21, 1992] (i) The official establishment has satisfactorily operated under a total plant § 381.146 Sampling at official establish- quality control system for at least 1 ments. year. Inspectors may take, without cost to (ii) All products prepared and the Department, such samples as are packaged, or processed after the end of necessary of any poultry product, or 8 hours of inspection shall only be a other article for use as an ingredient of continuation of the processing mon- any poultry product, at any official es- itored by the inspector and being con- tablishment to determine whether it ducted during the last hour of inspec- complies with the requirements of the tion. regulations. (iii) All immediate containers of products prepared and packaged shall § 381.147 Restrictions on the use of bear code marks that are unique to any substances in poultry products. period of production beyond the 8 hours (a) All ingredients and other sub- of inspection. The form of such code stances used in the processing or han- marks will remain constant from day dling of poultry products at official es- to day, and a facsimile of the code tablishments shall be such as will not marks and their meaning shall be pro- result in adulteration or misbranding vided to the inspector. of the poultry products. (2) Application. Applications shall be (b) Poultry products and poultry submitted to the Regional Director and broth used in the processing of poultry shall specify how the conditions in products shall have been processed in § 381.145(h)(1) have been or will be met. the United States only in an official es- (3) Monitoring by Inspectors. In order tablishment, or imported from a for- to verify that an establishment is pre- eign country listed in § 381.196(b), and paring and shipping product in accord- inspected and passed, in accordance ance with the approved total plant with the regulations. Detached ova and quality control system and the Act and offal shall not be used in the processing regulations after the 8 hours of inspec- of any poultry products, except that tion, the official establishment may be poultry feet may be processed for use provided overtime inspectiom services as human food when handled in a man- at the discretion of the circuit super- ner approved by the Administrator in visor and charged for such services. specific cases, and detached ova may be (i) Containers with substances ap- used in the processing of poultry prod- proved for use in the processing of ucts if the processor demonstrates that products in § 381.147(f)(3) of this sub- such ova comply with the requirements chapter which enter any official estab- under the Federal Food, Drug, and Cos- lishment for use in poultry scald water metic Act.

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(c) Liquid, frozen, and dried egg prod- (f)(1) No substance may be used as an ucts used in the processing of any poul- ingredient or otherwise in the process- try product shall have been prepared ing of any raw or cooked poultry prod- under inspection and be so marked in uct unless its use is approved as shown accordance with the Egg Products In- in Table 1 of paragraph (f)(4) of this spection Act. section, or elsewhere in this part, or by (d)(1) Carcasses, parts thereof, meat the Administrator in specific cases. and meat food products of cattle, (2) Approval of new substances or sheep, swine, goats, or equines may be new uses or new levels of use of ap- used in the processing of poultry prod- proved substances may be granted if: ucts only if they were prepared in the (i) The substance has been previously United States only in an official meat approved by the Food and Drug Admin- packing establishment, or imported, istration (FDA) for use in poultry or and were inspected and passed, in ac- poultry products as a food additive, cordance with the Federal Meat Inspec- color additive or as a substance gen- tion Act, and the regulations under erally recognized as safe and is listed such Act (subchapter A of this chapter) in title 21 of the Code of Federal Regu- and are so marked. lations, parts 73, 74, 81, 172, 173, 182, or (2) Pork from carcasses or carcass 184. parts, used as an ingredient in poultry (ii) Its use is in compliance with ap- products, that has been found free of plicable FDA requirements; and trichinae, as described under § 318.10 (iii) The Administrator has deter- (a)(2), (e) and (f) of the Federal meat mined that: inspection regulations (9 CFR 318.10 (A) The use of the substance will not (a)(2), (e) and (f)), is not required to be render the product in which it is used treated for the destruction of adulterated or misbranded or otherwise trichinae. not in compliance with the Act; and (3) Poultry products containing pork (B) Its use is functional and suitable muscle tissue which the Administrator for the product and it is permitted for determines at the time the labeling for use at the lowest level necessary to ac- the product is submitted for approval complish the desired technical effect as in accordance with part 381 of the regu- determined in specific cases. lations in subchapter C, or upon subse- (3) Whenever the Administrator de- quent reevaluation of the product, termines that approval of a new sub- would be prepared in such a manner stance or a new use or new level of use that the product might be eaten rare or of an approved substance should be without thorough cooking because of granted in accordance with pararaph the appearance of the finished product (f)(1) of this section, the Administrator or otherwise, shall be effectively heat- shall issue a final rule amending Table ed, refrigerated, or cured to destroy 1 of paragraph (f)(4) of this section to any possible live trichinae, as pre- include the additional substance or scribed in § 318.10(c) of the Federal new use of the substance, and any tech- meat inspection regulations (9 CFR nical effect or change in the level of 318.10(c)), at the official establishment use of the substance. where such products are prepared. In (4) No poultry product shall bear or lieu of such treatment of poultry prod- contain any substance which would ucts containing pork, the pork ingredi- render it adulterated or misbranded, or ent may be so treated. which is not approved in Part 381 or by (e) [Reserved] the Administrator in specific cases.

TABLE I [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Acidifiers ...... Acetic acid ...... To adjust acidity ...... Various 3 ...... Sufficient for purpose.4 Citric acid ...... do ...... do ...... Do. Glucono delta-lactone ...... do ...... do ...... Do. Lactic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do.

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Tartaric acid ...... do ...... do ...... Do. Antifoaming Methyl polysilicone .... To retard foaming ...... Soups ...... 10 ppm. agent. Rendered fats ...... 10 ppm. Curing pickle ...... 50 ppm. Antimicrobial Trisodium phosphate To reduce microbial Raw, chilled poultry 8 to 12 percent; solution to be agents. levels. carcasses. maintained at 45 °F. to 55 °F. and applied by spraying or dipping carcasses for up to 15 seconds in accordance with 21 CFR 182.1778. Antioxidants and BHA (butylated To retard rancidity ..... Various ...... 0.01 percent based on fat content. oxygen inter- hydroxyanisole). (0.02 percent in combination with ceptors. any other antioxidant listed in this table based on fat content.) BHT (butylated ...... do ...... do ...... Do. hydroxytoluene). Propyl gallate ...... do ...... do ...... 0.01 percent based on fat content. (0.02 percent in combination with any other antioxidant listed in this table, except TBHQ, based on fat content.) TBHQ (tertiary ...... do ...... do ...... 0.01 percent based on fat content. butylhydroquinone). (0.02 percent in combination only with BHA and/or BHT based on fat content.) Tocopherols ...... do ...... do ...... 0.03 percent based on fat content. (0.02 percent in combination with any other antioxidant listed in this table, except TBHQ, based on fat content.)

Binders and ex- A mixture of sodium To bind poultry pieces Ground and formed Sodium alginate not more than tenders. alginate, calcium raw or cooked poul- 0.8%, calcium carbonate not carbonate, lactic try pieces. more than 0.15%, lactic acid and acid, and calcium calcium lactate, in combination, lactate. not more than 0.6% of product formulation. Added mixture may not exceed 1.55% of product at formulation. The mixture must be added in dry form. Algin ...... To extend and sta- Various ...... Sufficient for purpose. bilize product. Carrageenan ...... do ...... do ...... Do. Carboxymethyl cel- ...... do ...... do ...... Do. lulose (cellulose gum). Enzyme (rennet) To bind and extend Various ...... Sufficient for purpose. (Calcium treated calcium re- product. lactate required at rate of 10 per- duced dried skim cent of binder.) milk and calcium lactate. Enzyme (rennet) ...... do ...... do ...... Sufficient for purpose. (calcium lac- treated sodium ca- tate required at rate of 25 per- seinate and calcium cent of binder.) lactate. Gelatin ...... do ...... do ...... Sufficient for purpose in accordance with 21 CFR 172.5. Gums, vegetable ...... do ...... do ...... Do. Methyl cellulose ...... To extend and to sta- ...... do ...... 0.15 percent. bilize product (also carrier). Isolated soy protein ... To bind and extend ...... do ...... Sufficient for purpose. product. Sodium caseinate ...... do ...... do ...... 3 percent in cooked product, 2 percent in raw product; in accordance with 21 CFR 172.5 and 182.1748. Tapioca dextrin ...... do ...... do ...... Sufficient for purpose in accordance with 21 CFR 184.1277.

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Wheat gluten ...... do ...... do ...... Sufficient for purpose in accordance with 21 CFR 184.1322. Whey (dried) ...... do ...... do ...... Do. Xanthan gum ...... To maintain: Uniform Various, except Do. viscosity; suspen- uncooked products sion of particulate or sausages or matter; emulsion other products with stability; freeze- a moisture limitation thaw stability. established by Sub- part P of this Part. Chilling media ... Salt (NaCl) ...... To aid in chilling ...... Raw poultry products 700 lbs. to 10,000 gals. of water.1 Coloring agents Annatto, Carotene ..... To color products ...... Various ...... Sufficient for purpose. (natural). Coloring agents Coal tar dyes (FD&C To color products; to ...... do ...... Do. (artificial). certified), Titanium whiten products. Salads and spreads .. 0.05 percent. dioxide. Curing accelera- Ascorbic acid ...... To accelerate color Cured poultry; cured, 75 oz to 100 gal pickle at 10 per- tors; must be fixing. comminuted poultry cent pump level; 3¤4 oz to 100 lb used only in products. of poultry product; 10 percent so- combination lution to surfaces of the product with curing prior to packaging. (The use of agents. such solution shall not result in the addition of a significant amount of moisture to the product.) Erythorbic acid ...... do ...... do ...... Do. Fumaric acid ...... do ...... Cured, comminuted 0.065 percent (or 1 oz to 100 lb) of poultry or poultry the weight of the poultry or poul- products. try byproducts, before processing. Sodium ascorbate ...... do ...... do ...... 87.5 oz to 100 gal pickle at 10 percent pump level; 7¤8 oz to 100 lb of poultry product; 10 percent solution to surfaces of product prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.) Sodium erythorbate ...... do ...... do ...... Do. Citric acid or sodium ...... do ...... do ...... May be used in cured products to citrate. replace up to 50 percent of the ascorbic acid or sodium ascorbate that is used. Curing agents ... Sodium or potassium Source of nitrite ...... do ...... 7 lb to 100 gal pickle; 31¤2 oz. to nitrate. 100 lb or poultry product (dry cure); 23¤4 oz to 100 lb of chopped poultry meat. Sodium or potassium To fix color ...... Cured products ...... 2 lb to 100 gal pickle at 10 percent nitrite. (Supplies of pump level; 1 oz to 100 lb of sodium nitrite and poultry product (dry cure); 1¤4 oz potassium nitrite to 100 lb chopped poultry meat. and mixtures con- The use of nitrites, nitrates, or taining them must combination shall not result in be kept securely more than 200 ppm of nitrite, cal- under the care of a culated as sodium nitrite, in fin- responsible em- ished product. ployee of the establishment. The specific nitrite content of such supplies must be known and clearly marked accordingly.). Emulsifying Acetylated To emulsify product ... Various ...... Sufficient for purpose. agents. monoglycerides. Diacetyl tartaric acid ...... do ...... Rendered poultry fat Do. esters of mono- or a combination of and diglycerides. such fat with vegetable fat.

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Glycerol-lacto stea- ...... do ...... do ...... Do. rate, oleate or palmitate. Lecithin ...... To emulsify product Various ...... Do. (also as antioxidant). Mono- and To emulsify product ...... do ...... Do. diglycerides (glycerol palmitate, etc.). Polysorbate 80 To emulsify product ... Various ...... 1 percent when used alone. If used (polyoxyethylene with polysorbate 60, the com- (20) sorbitan bined total shall not exceed 1 monooleate). percent. Propylene glycol ...... do ...... Rendered poultry fat Sufficient for purpose. mono- and diesters or a combination of of fats and fatty such fat with vege- acids. table fat. Polysorbate 60 ...... do ...... do ...... 1 percent when used alone. If used (polyoxyethylene with polysorbate 80, the com- (20) sorbitan mono- bined total shall not exceed 1 stearate). percent. Flavoring Artificial smoke flavor- To flavor product ...... Various ...... Sufficient for purpose. agents; pro- ing.. tectors and developers. Smoke flavoring ...... do ...... do ...... Do. Autolyzed yeast ex- ...... do ...... do ...... Do. tract. Citric acid ...... To protect flavor ...... do ...... Do. Corn syrup solids; To flavor product ...... do ...... Do. corn syrup; glucose syrup. Disodium inosinate ...... do ...... do ...... Do. Disodium guanylate ...... do ...... do ...... Do. Hydrolyzed plant pro- ...... do ...... do ...... Do. tein. Malt syrup ...... do ...... do ...... Do. Milk protein hydroly- ...... do ...... do ...... Do. sate. Monosodium glu- ...... do ...... do ...... Do. tamate. Monoammonium glu- ...... do ...... do ...... Do. tamate. Sodium sulfoacetate ...... do ...... do ...... 0.5 percent. derivative of mono and diglycerides. Sugars approved ...... do ...... do ...... Sufficient for purpose. (surcose and dextrose). Potassium lactate ...... To flavor product ...... Various poultry and Not to exceed 2 percent of formula- poultry food prod- tion; in accordance with 21 CFR ucts, except infant 184.1639. formula and infant food. 3 Sodium lactate ...... do...... do...... Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1768. Gases ...... Carbon dioxide solid To cool product or fa- Various ...... Do. (dry ice). cilitate chopping or packaging. Carbon dioxide liquid Contact freezing ...... do ...... Do. Nitrogen ...... To exclude oxygen ...... do ...... Do. from sealed containers. Nitrogen liquid ...... Contact freezing ...... do ...... Do. Miscellaneous ... Sodium bicarbonate .. To neutralize excess Rendered fat, soups, Do. acidity; cleaning curing pickle. vegetables.

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Calcium propionate ... To retard mold growth Fresh pie dough ...... 0.3 percent of calcium propionate or sodium propionate alone, or in combination, based on weight of the flour used. Sodium hydroxide ..... To decrease the Poultry food products May be used only in combination amount of cooked containing phos- with phosphate in a ratio not to out juices. phates. exceed one part sodium hydroxide to four parts phosphate. Sodium propionate .... To retard mold growth Fresh pie dough ...... 0.3 percent of calcium propionate or sodium propionate alone, or in combination, based on weight of the flour used. Disodium phosphate To decrease the Poultry food products 0.5 percent of total product. amount of cooked except where other- out juices. wise prohibited by the poultry products inspection regulations. Monosodium phos- ...... do ...... do ...... Do. phate. Sodium ...... do ...... do ...... Do. metaphosphate, insoluble. Sodium ...... do ...... do ...... Do. polyphosphate, glassy. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sodium ...... do ...... do ...... Do. pyrophosphate. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Dipotassium phos- ...... do ...... do ...... Do. phate. Monopotassium phos- ...... do ...... do ...... Do. phate. Potassium ...... do ...... do ...... Do. tripolyphosphate. Potassium ...... do ...... do ...... Do. pyrophosphate. Tricalcium phosphate To preserve product Mechanically deboned Not to exceed 2 percent of the color during dehy- chicken to be dehy- weight of the mechanically dration process. drated. deboned chicken prior to dehy- dration, in accordance with 21 CFR 182.1217. Sodium citrate To inhibit the growth Cured and uncured, Not to exceed 1.3 percent of the buffered with citric of micro-organisms processed whole- formulation weight of the product acid to a pH of 5.6. and retain product muscle poultry food in accordance with 21 CFR flavor during stor- products, e.g., 184.1751. age. chicken breasts. Poultry scald Alpha-hydro-omega- To remove feathers ... Poultry carcasses ...... Not to exceed 0.05% by weight in agents; must hydroxy-poly scald water. be removed (oxyethylene) poly by subse- (oxypropylene) quent clean- (minimum 15 ing operations. moles) poly (oxyethylene) block copolymer (polyoxamer). Dimethylpolysiloxane ...... do ...... do ...... Sufficient for purpose. Dioctyl sodium ...... do ...... do ...... Do. sulfosuccinate. Dipotassium phos- ...... do ...... do ...... Do. phate. Ethylenediamine- ...... do ...... do ...... Do. tetraacetic acid (sodium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide).

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Polyoxyethylene (20) ...... do ...... do ...... Not to exceed 0.0175% in scald sorbitan water. monooleate. Potassium hydroxide ...... do ...... do ...... Sufficient for purposes. Propylene glycol ...... do ...... do ...... Do. Sodium acid phos- ...... do ...... do ...... Do. phate. Sodium bicarbonate ...... do ...... do ...... Do. Sodium carbonate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. dodecylbenzene- sulfonate. Sodium-2-ethylhexyl ...... do ...... do ...... Do. sulfate. Sodium ...... do ...... do ...... Do. hexametaphosphat- e. Sodium hydroxide ...... do ...... do ...... Do. Sodium lauryl sulfate ...... do ...... do ...... Do. Sodium phosphate ...... do ...... do ...... Do. (mono-, di-, tribasic). Sodium ...... do ...... do ...... Do. pyrophosphate. Sodium ...... do ...... do ...... Do. sesquicarbonate. Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Tetrasodium ...... do ...... do ...... Do. pyrophosphate. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sodium ...... do ...... do ...... Do. pyrophosphate. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Proteolytic en- Aspergillus oryzae ..... To soften tissue ...... Raw poultry muscle Solutions consisting of water and zymes. tissue of hen, cock, approved proteolytic enzyme ap- mature turkey, ma- plied or injected into raw poultry ture duck, mature tissue shall not result in a gain of goose, and mature more than 3 percent above the guinea. weight of the untreated product. Aspergillus flavus ...... do ...... do ...... Do. oryzze group. Bromelin ...... do ...... di ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Radiation Ionizing radiation For control of food- Fresh or frozen, Minimum absorbed dose of 1.5 Sources. sources as ap- borne pathogens uncooked, kiloGray (150 kilorads) to a maxi- proved in 21 CFR packaged poultry mum absorbed dose of 3.0 179.26(a) products that are: kiloGray (300 kilorads). (1) Whole carcasses or disjointed portions of such carcasses that are ``ready-to-cook,'' which includes such poultry products as fresh or frozen, uncooked ground, hand-boned, and skinless poultry, (2) mechanically separated poultryÐa finely comminuted ingredient produced by the mechanical deboning of poultry carcasses or parts of carcasses

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TABLE IÐContinued [See footnotes at end of this table]

Class of substance Substance Purpose Products Amount

Synergists (used Citric acid ...... To increase effective- Poultry fats ...... 0.01 percent alone or in combina- in combination ness of antioxidants. tion with antioxidants in poultry with anti- fats. oxidants). Malic acid ...... do ...... do ...... Do. Monoisopropyl citrate ...... do ...... do ...... 0.01 percent poultry fats. Phosphoric acid ...... do ...... do ...... 0.01 percent. Monoglyceride citrate ...... do ...... do ...... 0.02 percent. Tenderizing Aspergillus oryzae ..... To soften tissue ...... Raw poultry muscle Solutions consisting of water and agents. tissue of hen, cock, approved proteolytic enzymes mature turkey, ma- applied or injected into raw poul- ture duck, mature try tissue shall not result in a goose, and mature gain of more than 3 percent guinea. above the weight of the untreated product. Aspergillus ...... do ...... do ...... Do. flavusoryzae group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Potassium chloride ...... do ...... do ...... Not more than 3 percent of a 2.0 molar solution. Magnesium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Calcium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Potassium, magne- ...... do ...... do ...... A solution of approved inorganic sium or calcium chlorides alone or in combina- chloride. tion, applied or injected into raw poultry muscle tissue shall not result in a gain of more than 3 percent above the weight of the untreated product. 1 Special labeling requirements are prescribed in § 381.120 for raw poultry products chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water. 2 [Reserved] 3 Information as to the specific products for which use of this substance is approved may be obtained upon inquiry addressed to the Standards and Labeling Division, Meat and Poultry Inspection Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, South Building, 14th Street and Independence Avenue SW., Washington, DC 20250. 4 Provided, that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under § 381.32. [37 FR 9706, May 16, 1972]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 381.147, see the List of CFR Sections Affected in the Finding Aids section of this volume.

§ 381.148 Processing and handling re- lishment where products to be frozen quirements for frozen poultry prod- are prepared, except that, upon written ucts. request, and under such conditions as Procedures with respect to process- may be prescribed by the Adminis- ing of frozen ready-to-heat-and-eat trator in specific cases, such products poultry products or stuffed ready-to- may be moved from the official estab- roast poultry shall be in accordance lishment prior to freezing: Provided, with sound operating practices and car- That the official establishment and ried out in a manner which will assure freezer are so located and the necessary freedom from adulteration of the prod- arrangements are made so that the In- ucts. Products to be frozen shall be spection Service will have access to the moved into the freezer promptly under freezing room and adequate oppor- such supervision by an inspector as is tunity to determine that the products necessary to assure preservation of the are being properly handled and frozen. products by prompt and efficient freezing. Adequate freezing facilities shall be provided within the official estab-

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§ 381.149 Irradiation of poultry prod- that all data and information gen- uct to control foodborne pathogens. erated by the system will be main- (a) Definitions of food irradiation tained to enable the Department to terms: monitor compliance. The quality con- (1) Absorbed dose is the amount of en- trol system will be evaluated and ap- ergy imparted by ionizing radiation to proved in accordance with § 381.145(e) of a quantity of product. this Subpart. A copy of the description (2) Bulk density is the mass (weight) will be placed on file in the irradiation of a product unit divided by its total facility and be available to any duly volume. authorized representative of the Sec- (3) Dose mapping is the identification retary. At a minimum, the operator of of the regions of minimum and maxi- the irradiation facility must establish mum absorbed dose in a product unit. and comply with a quality control sys- (4) A dosimeter is the device for meas- tem which provides for the following: uring absorbed dose. (1) Licensing, Sanitation, and Facil- (5) Dosimetry is the process of measur- ity. (i) Documentation showing that ing absorbed dose. the irradiation facility is licensed and/ (6) Ionizing radiation is radiation with or possesses gamma radiation sources sufficient energy to cause the removal registered with the Nuclear Regulatory of electrons from atoms or molecules, Commission (NRC) or the appropriate thereby creating ions. State government acting under author- (7) Irradiate means to expose a mate- ity granted by the NRC, and that a rial to ionizing radiation. worker safety program addressing reg- (8) A product unit is the volume of ulations of the Occupational Safety product, made up of one or more pack- and Health Administration (OSHA) is ages of product, which is collectively in place. transported past the radiation source (ii) Documentation showing that the (e.g., in boxes or totes or on pallets or machine radiation source irradiation carriers). facility is registered with the Occupa- (9) A production lot is the quantity of tional Safety and Health Administra- like product units designated as such tion (OSHA) or the appropriate State by the operator of the irradiation facil- government acting under authority ity or their agent to be processed in no granted by OSHA, and that a worker more than one continuous shift of up safety program addressing OSHA regu- to 8 hours. lations is in place. (10) Radiation source is the radio- (iii) Procedures to ensure that the ir- active material (e.g., cobalt-60) or ma- radiation facility complies with the ap- chine that emits ionizing radiation. plicable provisions of Subpart H of this (11) Source activity decay is the de- Part, as determined by the Adminis- crease in the radioactivity of radio- trator. nuclide source material (e.g., cobalt-60) (iv) Procedures to ensure that, if the with the passing of time. facility has no refrigerated storage ca- (12) Traceability is the capacity, pacity, adequate numbers of refrig- through documentation, to relate an erated units (such as trucks or car- end-point measurement to recognized riers) will be made available during the standards. radiation processing of poultry. (b) Poultry product may be treated (2) Training. (i) A statement by the to reduce foodborne pathogens by the operator certifying that the irradiation use of ionizing radiation as identified facility personnel would operate under in § 381.147(f)(4) of this subpart. Only ir- supervision of a person who has suc- radiation facilities operating under a cessfully completed a course of instruc- FSIS-approved quality control system, tion for operators of food irradiation in accordance with paragraph (c) of facilities. this section, may irradiate poultry (ii) A statement by the operator cer- product for food uses. tifying that the key facility quality (c) A description of the quality con- control personnel have been trained in trol system must be sent to the Admin- quality control, food technology, irra- istrator identifying the responsible of- diation processing, and radiation ficial for quality control and stating health and safety.

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(3) Poultry Product; Packaging, han- (ii) Calibration criteria for verifying dling. (i) Procedures to ensure that the accuracy and consistency of any each production lot of packaged poul- means of measurement (e.g., time try is accompanied by a certificate or clocks and weight scales). traceable certification that states that (iii) Calibration and accountability the food-contact packaging material is criteria for verifying the traceability guaranteed by the supplier as comply- and accuracy of dosimeters for the in- ing with the Federal Food, Drug, and tended purpose, and the verification of Cosmetic Act (21 U.S.C. 301 et seq.) and calibration at least every 12 months. regulations in 21 CFR 179.45 for food ir- (iv) Procedures for assuring the prod- radiation processing and that the food- uct unit is dose mapped to identify the contact packaging material is air-per- regions of minimum and maximum ab- meable, but does exclude moisture and sorbed dose and such regions are con- microorganisms from penetrating the sistent from one product unit to an- package barrier. other of like product. (ii) Procedures to ensure that product units throughout each production (v) Procedures for accounting for the lot are uniform in size, weight, thick- total absorbed dose received by the ness, and orientation to the radiation product unit (e.g., partial applications source. of the absorbed dose within one produc- (iii) Procedures to ensure that pack- tion lot). ages are distributed throughout each (vi) Procedures for verifying routine production lot uniformly with respect dosimetry (i.e., assuring each produc- to package stacking arrangements, tion lot receives the total absorbed bulk density, and orientation of the dose). Each production lot must have packages to the radiation source. at least one dosimeter positioned at (iv) Procedures to ensure that the the regions of minimum and maximum product(s) is uniform throughout the absorbed dose (or at one region verified production lot (e.g., all wings, all to represent such) on at least the first, breasts, all combination packages of middle, and last product unit. breasts and wings). (vii) Procedures for verifying the re- (v) Procedures to ensure that product lationship of absorbed dose as meas- temperature is kept uniform within a ured by the dosimeter to time exposure production lot, such that fresh refrig- of the product unit to the radiation erated product is processed separately source. from frozen product. (viii) Procedures for verifying the in- (vi) Procedures to ensure that prod- tegrity of the radiation source and uct unit bulk density is uniform processing procedure. Aside from ex- throughout a production lot. pected and verified radiation source ac- (vii) Procedures to ensure that prod- tivity decay for radionuclide sources, uct is kept intact and in sealed pack- the radiation source or processing pro- ages. cedure must not be altered, modified, (viii) Procedures to ensure that prod- replenished, or adjusted without re- uct is not reirradiated. peating dose mapping of product units (ix) Procedures to ensure that non-ir- to redefine the regions of minimum radiated product is not commingled and maximum absorbed dose. with irradiated product. (5) Labeling. Procedures for verifying (x) Procedures to ensure that irradi- that the product is accurately and ap- ated product within each production propriately labeled in accordance with lot is identified to permit product re- § 381.135. call. (6) Transportation, Storage, and Han- (xi) Procedures to dispose of poultry dling. Procedures for assuring that with damaged packaging or poultry temperature and time requirements of which has been improperly irradiated. subpart I, § 381.66 are maintained dur- (4) Dosimetry. ing shipping of the poultry product to (i) Laboratory operation procedures the irradiation facility, radiation proc- for determining the absorbed dose essing, storage, and shipping of poultry value from the dosimeter. product to the point of purchase.

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(7) Corrective Action. (i) Procedures mediately fully cooked to the required for corrective action for failure to ad- 160 °F. internal temperature. here to any of the above procedures. [37 FR 9706, May 16, 1972, as amended at 55 (ii) Procedures to dispose of product FR 23072, June 6, 1990] affected during the failure to adhere to any of the above procedures. § 381.151 Adulteration of product by (iii) Procedures to prevent polluted water; procedure for han- reocurrence of any failures to adhere to dling. any of the above procedures. (a) In the event there is polluted (d) The quality control system shall water (including but not limited to be subject to periodic review, and the flood water) in an official establish- approval of such system may be termi- ment, all poultry products and ingredi- nated in accordance with § 381.145(g) of ents for use in the preparation of such this subpart. products that have been rendered adulterated by the water shall be con- [57 FR 43598, Sept. 21, 1992] demned. (b) After the polluted water has re- § 381.150 Requirements for the produc- ceded from an official establishment, tion of poultry breakfast strips, all walls, ceilings, posts, and floors of poultry rolls, and certain other the rooms and compartments involved, poultry products. including the equipment therein, shall, (a) Poultry breakfast strips are cured under the supervision of an inspector, and smoked products which require be cleaned thoroughly by the official special handling during distribution establishment personnel. An adequate and additional cooking before con- supply of hot water under pressure is sumption. These products shall be essential to make such cleaning effec- heated to an internal temperature of tive. After cleaning a solution of so- 140 °F. After heating in the establish- dium hypochlorite containing approxi- ment, these products must be cooled to mately one-half of 1 percent available 80 °F. within 1.5 hours and to 40 °F. chlorine (5,000 p/m) or other equivalent within 5 hours. Labeling for these prod- disinfectant approved by the Adminis- ucts shall comply with § 381.125 of this trator 1 shall be applied to the surface part. In addition, the statement ‘‘Par- of the rooms and equipment and rinsed tially Cooked: For Safety, Cook Until with potable water before use. Well Done’’ shall appear on the prin- (c) Hermetically sealed containers of cipal display panel in letters no small- poultry product which have been con- er than 1⁄2 the size of the largest letter taminated by polluted water shall be in the product name. Detailed cooking examined promptly by the official es- instructions shall be provided on the tablishment under supervision of an in- immediate container of the products. spector and rehandled as follows: (b) Except for product produced in ac- (1) Separate and condemn all poultry cordance with paragraph (a) of this sec- products in damaged or extensively tion, all poultry rolls and other poultry rusted containers. (2) Remove paper labels and wash the products that are heat processed in any remaining containers in warm soapy manner shall reach an internal tem- water, using a brush where necessary perature of at least 160 °F. prior to to remove rust or other foreign mate- being removed from the cooking me- rial. Disinfect these containers by ei- dium, except that cured and smoked ther of the following methods: poultry rolls and other cured and (i) Immerse in a solution of sodium smoked poultry products shall reach an hypochlorite containing not less than ° internal temperature of at least 155 F. 100 p/m of available chlorine or other prior to being removed from the cook- equivalent disinfectant approved by ing medium. Notwithstanding the other provisions of this section, prod- 1 A list of approved disinfectants is avail- uct to which heat will be applied inci- able upon request to Scientific Services, dental to a subsequent processing pro- Meat and Poultry Inspection Program, Food cedure may be removed from the media Safety and Inspection Service, U.S. Depart- for such processing provided it is im- ment of Agriculture, Washington, DC 20250.

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the Administrator,1 rinse in potable ble products department if the article water, and dry thoroughly; or is properly identified. (ii) Immerse in 212 °F. water, bring (b) Requirements applicable when pre- temperature of the water back to 212 pared in an inedible products department. °F. and maintain the temperature at When an article (including, but not 212 °F. for 5 minutes, then remove con- being limited to, animal food) that is tainers from water and cool them to 95 not for use as human food, is prepared °F. and dry thoroughly. in any part of an official establishment (3) After handling as described in other than an edible products depart- paragraph (c)(2) of this section, the ment (such part of the establishment containers may be relacquered, if nec- being herein referred to as the ‘‘ined- essary, and then relabeled with ap- ible products department’’), the area in proved labels applicable to the product which such article is prepared shall be therein. distinctly separated from all edible (4) The identity of the canned poultry products departments. Poultry prod- product shall be maintained through- ucts and inedible products may be out all stages of the rehandling oper- brought from any edible products de- ations, to insure correct labeling of partment into any inedible products containers. department, but no poultry product or [38 FR 34456, Dec. 14, 1973] inedible product may be brought from an inedible products department into § 381.152 Preparation in an official es- an edible products department except tablishment of articles not for that any such articles as are in sealed human food. containers or are handled under condi- (a) Requirements applicable when pre- tions prescribed or approved by the Ad- pared in an edible products department. ministrator in specific cases may be When an article (including, but not brought into an edible products depart- being limited to, animal food) that is ment. Diseased carcasses or diseased not for use as human food is prepared parts of any carcass shall not be used in any room or compartment, in an of- in the preparation of any animal food ficial establishment where poultry unless they have been treated in the products are prepared or handled (such manner prescribed in § 381.95(a). Trucks room or compartment being herein re- or containers used for the transpor- ferred to as an ‘‘edible products depart- tation of poultry products or inedible ment’’), sufficient space and equipment products into an inedible products de- shall be provided to assure that the partment shall be cleaned before being preparation of the article in no way returned to or brought into an edible interferes with the preparation or products department. Sufficient space other handling of the poultry products. shall be allotted and adequate equip- Where necessary, separate equipment ment and facilities provided so that the shall be provided for the preparation of preparation of the article does not the article. To assure the maintenance interfere with the preparation of poul- of the requisite sanitary conditions in try products or the maintenance of the the edible products department, the op- requisite sanitary conditions in the of- erations incident to the preparation of ficial establishment. The preparation the article shall be subject to the same of any such article shall be subject to sanitary requirements as apply to the supervision by an inspector. handling of poultry products in the edi- (c) Containers to be labeled. The imme- ble products department. Preparation diate container of any such article that of the article shall be limited to those is prepared in an official establishment hours during which the official estab- shall be conspicuously labeled so as to lishment operates under the super- distinguish it from human food. Such vision of an inspector. The ingredients articles are also subject to the require- used in the preparation of the article ments under the Federal Food, Drug, shall, unless otherwise approved by the and Cosmetic Act. Administrator in specific cases, be such as may be used in the preparation of a § 381.153 Accreditation of chemistry poultry product. The article may be laboratories. stored in, and distributed from, the edi- (a) Definitions:

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Accreditation—Determination by Chemical residue misidentification—see FSIS that a laboratory is qualified to ‘‘Correct Chemical Residue Identifica- analyze official samples of product sub- tion’’ definition. ject to regulations in this subchapter Coefficient of variation (CV)—The and subchapter A of this chapter for standard deviation of a distribution of the presence and amount of all four analytical values multipled by 100, and food chemistry analytes (protein, mois- divided by the mean of those values. ture, fat, and salt); or a determination Comparison Mean—The average, for a by FSIS that a laboratory is qualified sample, of all accredited and FSIS lab- to analyze official samples of product oratories’ average results, each of subject to regulations in this sub- which has a large deviation measure of chapter and subchapter A of this chap- zero, except when only two labora- ter for the presence and amount of one tories perform the analysis, as in the of several classes of chemical residue, case of split sample analysis by both an in accordance with the requirements of accredited laboratory and an FSIS lab- the Accredited Laboratory Program. oratory. In the latter case, the com- Accreditations are granted separately parison mean is the average of the two for the food chemistry analysis of offi- laboratories’ results. For food chem- cial samples and for the analysis of istry, a result for a laboratory is the such samples for any one of the several obtained analytical value; for chemical residues, a result is the logarithmic classes of chemical residue. A labora- transformation of the obtained analyt- tory may hold more than one accredi- ical value. tation. Correct chemical residue identifica- Accredited laboratory—A non-Federal tion—Correct identification by a lab- analytical laboratory that has met the oratory of a chemical residue whose requirements for accreditation speci- concentration, in a sample, is equal to fied in this section and hence, at an es- or greater than the minimum reporting tablishment’s discretion, may be used level for that residue, as determined by in lieu of an FSIS laboratory for ana- the median of all positive analytical lyzing official regulatory samples. Pay- values obtained by laboratories analyz- ment for the analysis of official sam- ing the sample. Failure of a laboratory ples is to be made by the establishment to report the presence of such a chemi- using the accredited laboratory. cal residue is considered a AOAC methods—Methods of chemical misidentification. In addition, report- analysis, Chapter 39, Association of Of- ing the presence of a residue at a level ficial Analytical Chemists published in equal to or above the minimum report- the ‘‘Official Methods of Analysis of ing level that is not reported by 90 per- the Association of Official Analytical cent or more of all other laboratories Chemists’’, 15th edition 1990.1 The ‘‘Of- analyzing the sample, is considered a ficial Methods of Analysis of the Asso- misidentification. ciation of Official Analytical Chem- CUSUM—A class of statistical proce- ists,’’ 15th edition, 1990, is incorporated dures for assessing whether or not a by reference with the approval of the process is ‘‘in control’’. Each CUSUM Director of the Federal Register in ac- value is constructed by accumulating cordance with 5 U.S.C. 552(a) and 1 CFR incremental values obtained from ob- part 51. served results of the process, and then determined to either exceed or fall 1 A copy of the ‘‘Official Methods of Analy- within acceptable limits for that proc- sis of the Association of Analytical Chem- ess. The initial CUSUM values for each ists,’’ 15th edition, 1990, is on file with the laboratory whose application for ac- Director, Office of the Federal Register, and creditation is accepted are set at zero. may be purchased from the Association of The four CUSUM procedures are: Official Analytical Chemists, 2200 Wilson (1) Positive systematic laboratory Boulevard, Suite 400, Arlington, Virginia 22201. 15th edition, 1990, is incorporated by difference CUSUM (CUSUM–P)—mon- reference with the approval of the Director itors how consistently an accredited of the Federal Register in accordance with 5 laboratory gets numerically greater re- U.S.C. 552(a) and 1 CFR part 51. sults than the comparison mean;

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(2) Negative systematic laboratory Official Sample—A sample selected by difference CUSUM (CUSUM–N)—mon- an inspector or inspection service em- itors how consistently an accredited ployee in accordance with FSIS proce- laboratory gets numerically smaller dures for regulatory use. results than the comparison mean; Probation—The period commencing (3) Variability CUSUM (CUSUM–V)— with official notification to an accred- monitors the average ‘‘total discrep- ited laboratory that its check or split ancy’’ (i.e., the combination of the ran- sample results no longer satisfy the dom fluctuations and systematic dif- performance requirements specified in ferences) between an accredited labora- this rule, and ending with official noti- tory’s results and the comparison fication that accreditation is either mean; fully restored, suspended, or revoked. (4) Individual large discrepancy QA (quality assurance) recovery—The CUSUM (CUSUM–D)—monitors the ratio of a laboratory’s unadjusted ana- magnitude and frequency of large dif- lytical value of a check sample residue ferences between the results of an ac- to the residue level fortified by the credited laboratory and the comparison FSIS laboratory that prepared the mean. sample, multiplied by 100. (See Table Individual large deviation—An analyt- 2.) ical result from a non-Federal labora- QC (quality control) recovery—The tory that differs from the sample com- ratio of a laboratory’s unadjusted ana- parison mean by more than would be lytical value of a quality control stand- expected assuming normal laboratory ard to the fortification level of the variability. standard, multiplied by 100. (See Table Initial accreditation check sample—A 2.) sample prepared and sent by an FSIS Refusal of Accreditation—An action laboratory to a non-Federal laboratory taken when a laboratory which is ap- to ascertain if the non-Federal labora- plying for accreditation is denied the tory’s analytical capability meets the accreditation. standards for granting accreditation. Responsibly connected.—Any individ- Interlaboratory accreditation mainte- ual who or entity which is a partner, nance check sample—A sample prepared officer, director, manager, or owner of and sent by FSIS to a non-Federal lab- 10 per centum or more of the voting oratory to assist in determining if ac- stock of the applicant or recipient of ceptable levels of analytical capability accreditation or an employee in a man- are being maintained by the accredited agerial or executive capacity or any laboratory. employee who conducts or supervises Large deviation measure—A measure the chemical analysis of FSIS official that quantifies an unacceptably large samples. difference between a non-Federal lab- Revocation of Accreditation—An action oratory’s analytical result and the taken against a laboratory which re- sample comparison mean. moves its right to analyze official sam- Minimum proficiency level—The mini- ples. mum concentration of a residue at Split sample—An official sample di- which an analytical result will be used vided into duplicate portions, one por- to assess a laboratory’s quantification tion to be analyzed by an accredited capability. This concentration is an es- laboratory (for official regulatory pur- timate of the smallest concentration poses) and the other portion by an for which the average coefficient of FSIS laboratory (for comparison pur- variation (CV) for reproducibility (i.e., poses). combined within and between labora- Standardizing Constant—The number tory variability) does not exceed 20 per- which is the result of a mathematical cent. (See Table 2) adjustment to the ‘‘standardized Minimum reporting level—The number value.’’ Specifically, the number equals such that if any obtained analytical the square root of the expected vari- value equals or exceeds this number, ance of the difference between the ac- then the residue is reported together credited or applying laboratory’s result with the obtained analytical value. and the comparison mean on a sample,

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taking into consideration the standard- a positive systematic laboratory dif- izing value, the correlation and number ference and, conversely, numerically of repeated results by a laboratory on a smaller results indicate a negative sys- sample, and the number of laboratories tematic laboratory difference. that analyzed the sample. Variability—Random fluctuations in a Standardized Difference—The quotient laboratory’s processes that cause its of the difference between a laboratory’s analytical results to deviate from a result on a sample and the comparison true value. mean of the sample divided by the Variance—The expected average of standardizing constant. the squared differences of sample re- Standardizing Value—A number rep- sults from an expected sample mean. resenting the performance standard deviation of an individual result (see Ta- TABLE 1.ÐSTANDARDIZING VALUES FOR FOOD bles 1 and 2 and footnotes to the Tables CHEMISTRY for determining exact procedures for (By analyte) calculation). Suspension of Accreditation—Action Moisture Protein 1 Fat 2 Salt 3 taken against a laboratory which tem- 0.57 0.060 0.26 0.127 porarily removes its right to analyze (0.30) official samples. Suspension of accredi- 1 To obtain the standardizing value for a sample the appro- tation ends when accreditation is ei- priate entry in this column is multiplied by X0.65 where X is the comparison mean of the sample. ther fully restored or revoked. 2 To obtain the standardizing value for a sample, the appro- Systematic laboratory difference—A priate entry in this column is multiplied by X0.25, where X is the comparison mean of the sample. The appropriate entry is comparison of one laboratory’s results equal to the value in parentheses when X is equal to or great- with the comparison means on samples er than 12.5 percent, otherwise it is equal to 0.26. 3 To obtain the standardizing value for a sample, when the that shows, on average, a consistent re- comparison mean of the sample, X, is less than 1.0 percent, lationship. A laboratory that is report- the standardizing value equals 0.127, otherwise the appropriate entry is multiplied by X0.25. When X is equal to or great- ing, on average, numerically greater er than 4.0 percent for dry salami and pepperoni products, the results than the comparison mean has standardizing value equals 0.22.

TABLE 2.ÐMINIMUM PROFICIENCY LEVELS, PERCENT EXPECTED RECOVERIES (QC AND QA), AND STANDARDIZING VALUES FOR CHEMICAL RESIDUES

Minimum proficiency Percent ex- Standardizing Class of residues pected recovery 3 level (QC and QA) value

Chlorinated Hydrocarbons: 1 Aldrin ...... 0.10 ppm 80±110 0.20 Benzene Hexachloride ...... 0.10. ppm 80±110 0.20 Chlordane ...... 0.30 ppm 80±110 0.20 Dieldrin ...... 0.10 ppm 80±110 0.20 DDT ...... 0.15 ppm 80±110 0.20 DDE ...... 0.10 ppm 80±110 0.20 TDE ...... 0.15 ppm 80±110 0.20 Endrin ...... 0.10 ppm 80±110 0.20 Heptachlor ...... 0.10 ppm 80±110 0.20 Heptachlor Epoxide ...... 0.10 ppm 80±110 0.20 Lindane ...... 0.10 ppm 80±110 0.20 Methoxychlor ...... 0.50 ppm 80±110 0.20 Toxaphene ...... 1.00 ppm 80±110 0.20 Hexachlorobenzene ...... 0.10 ppm 80±110 0.20 Mirex ...... 0.10 ppm 80±110 0.20 Nonachlor ...... 0.15 ppm 80±110 0.20 Polychlorinated Biphenyls ...... 0.50 ppm 80±110 0.20 Arsenic 2 ...... 0.20 ppm 90±105 0.25 Sulfonamides 2 ...... 0.08 ppm 70±120 0.25 Volatile Nitrosamine 2 ...... 5 ppb 70±110 0.25 1 Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical residues. 2 Laboratory statistics are only computed for specific chemical residues. 3 The standardizing value of all initial accreditation and probationary check samples computations is 0.15.

(b) Laboratories accredited for analysis (1) Applying for accreditation. Applica- of protein, moisture, fat, and salt content tion for accreditation shall be made on of poultry and poultry products— designated forms provided by FSIS, or

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otherwise in writing, by the owner or the Accredited Laboratory Program manager of a non-Federal analytical are paid. laboratory and sent to the Accredited (v) The accreditation of a laboratory Laboratory Program, room 516–A, that was accredited by FSIS on or be- Annex Building, Food Safety and In- fore December 13, 1993 and was not on spection Service, U.S. Department of probation and whose accreditation on Agriculture, 300 12th Street SW., Wash- that date was not in suspension or rev- ington DC, 20250–3700, and shall specify ocation shall be continued, provided the kinds of accreditation that are that such laboratory reapply for ac- wanted by the owner or manager of the creditation in accordance with the pro- laboratory. A laboratory whose accred- visions of this paragraph (b)(1) by Jan- itation has been refused or revoked uary 13, 1994 (30 days of the effective may reapply for accreditation after 60 date of this section), and that the re- days from the effective date of that ac- application be accepted by the Agency. tion, and must provide written docu- The CUSUM values for such laboratory mentation specifying what corrections will be reset at zero upon acceptance of were made. its reapplication. The accreditation of (i) At the time that an Application a laboratory that is on probation shall for Accreditation is filed with the Ac- be continued, provided that the labora- credited Laboratory Program, FSIS, tory reapply for accreditation by Feb- and annually thereafter upon receipt of the bill issued by FSIS on the anniver- ruary 11, 1994 (60 days of the effective sary date of each accreditation, the date of this section), that the re- management of a laboratory shall reapplication be accepted by the Agency, imburse the program at the rate speci- and that the laboratory satisfy the fied in 9 CFR 391.5 for the cost of each terms of the probation. accreditation that is sought by the lab- (2) Criteria for obtaining accreditation. oratory or that the laboratory holds. Non-Federal analytical laboratories (ii) Simultaneously with the initial may be accredited for the analyses of application for accreditation, the man- moisture, protein, fat, and salt content agement of a laboratory shall forward of poultry and poultry products. Ac- a check, bank draft, or money order in creditation will be given only if the ap- the amount specified in 9 CFR 391.5 plying laboratory successfully satisfies made payable to the U.S. Department the requirements presented below, for of Agriculture along with the com- all four analytes. This accreditation pleted application for the accredita- authorizes official FSIS acceptance of tion(s) sought for the laboratory. Ac- the analytical test results provided by creditation will not be granted or con- these laboratories on official samples. tinued, without further procedure, for To obtain FSIS accreditation for mois- failure to pay the accreditation fee(s). ture, protein, fat, and salt analyses, a The fee(s) paid shall be nonrefundable non-Federal analytical laboratory and shall be credited to the account must: from which the expenses of the labora- (i) Be supervised by a person holding, tory accreditation program are paid. as a minimum, a bachelor’s degree in (iii) Annually on the anniversary either chemistry, food science, food date of each accreditation, FSIS will technology, or a related field and hav- issue a bill in the amount specified in ing 1 year’s experience in food chem- 9 CFR 391.5. istry, or equivalent qualifications, as (iv) Bills are payable upon receipt by determined by the Administrator. check, bank draft, or money order (ii) Demonstrate acceptable levels of made payable to the U.S. Department systematic laboratory difference, vari- of Agriculture and become delinquent ability, and individual large deviations 30 days from the date of the bill. Ac- in the analyses of moisture, protein, creditation will be terminated without fat, and salt content using AOAC meth- further procedure for having a delinquent account. The fee(s) paid shall be ods. An applying laboratory will suc- nonrefundable and shall be credited to cessfully demonstrate these capabili- the account from which the expenses of ties if its moisture, protein, fat, and

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salt results from a 36 check sample ac- of official samples, weekly, on des- creditation study each satisfy the cri- ignated forms to the FSIS Eastern teria presented below.2 If the labora- Laboratory, College Station Road, P.O. tory’s analysis of an analyte (or Box 6085, Athens, GA 30604, or to the analytes) from the first set of 36 check address designated by the Quality Sys- samples does not meet the criteria for tems Branch, FSIS Chemistry Division. obtaining accreditation, a second set of (ii) Maintain laboratory quality con- 36 check samples will be provided with- trol records for the most recent 3 years in 30 days following the date of receipt that samples have been analyzed under by FSIS of a request from the applying this Program. laboratory. The second set of samples (iii) Maintain complete records of the shall be analyzed for only the analyte(s) for which unacceptable ini- receipt, analysis, and disposition of of- tial results had been obtained by the ficial samples for the most recent 3 laboratory. If the results of the second years that samples have been analyzed set of samples do not meet the accredi- under this Program. tation criteria, the laboratory may re- (iv) Maintain a standards book, apply after a 60-day waiting period, which is a permanently bound book commencing from the date of refusal of with sequentially numbered pages, con- accreditation by FSIS. At that time, a taining all readings and calculations new application, all fees, and all docu- for standardization of solutions, deter- mentation of corrective action re- mination of recoveries, and calibration quired for accreditation must be sub- of instruments. All entries are to be mitted. dated and signed by the analyst imme- (A) Systematic laboratory difference: diately upon completion of the entry The absolute value of the average and by his/her supervisor within 2 standardized difference must not ex- working days. The standards book is to ceed 0.73 minus the product of 0.17 and be retained for a period of 3 years after the standard deviation of the standard- the last entry is made. ized differences. (v) Analyze interlaboratory accredi- (B) Variability: The estimated stand- tation maintenance check samples and ard deviation of the standardized differences must not exceed 1.15. return the results to FSIS within 3 (C) Individual large deviations: One weeks of sample receipt. This must be hundred times the average of the large done whenever requested by FSIS and deviation measures of the individual at no cost to FSIS. samples must be less than 5.0.3 (vi) Inform the Accredited Labora- (iii) Allow inspection of the laboratory Program, Room 516–A, Annex tory by FSIS officials prior to the de- Building, Food Safety and Inspection termination of granting accredited sta- Service, U.S. Department of Agri- tus. culture, 300 12th Street, SW., Washing- (iv) Pay the accreditation fee by the ton, DC 20250–3700, by certified or reg- date required. istered mail, within 30 days of any (3) Criteria for maintaining accredita- change in the laboratory’s ownership, tion. To maintain accreditation for officers, directors, supervisory person- moisture, protein, fat, and salt analy- nel, or other responsibly connected in- ses, a non-Federal analytical labora- dividual or entity. tory must: (vii) Permit any duly authorized rep- (i) Report analytical results of the resentative of the Secretary to perform moisture, protein, fat, and salt content both announced and unannounced on- site laboratory reviews of facilities and 2 All statistical computations are rounded records during normal business hours, to the nearest tenth, except where otherwise noted. and to copy any records pertaining to 3 A result will have a large deviation meas- the laboratory’s participation in the ure equal to zero when the absolute value of Accredited Laboratory Program. the result’s standardized difference, (d), is less than 2.5, and otherwise a measure equal to 1¥(2.5/d)4.

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(viii) Use official AOAC methods 4 on this computation yields a value small- official and check samples. The ‘‘Offi- er than 0, the new CUSUM–P value is cial Methods of Analysis of the Asso- set equal to 0. [CUSUM–P values are ciation of Official Analytical Chem- initialized at zero; that is, the CUSUM- ists,’’ 15th edition, 1990, is incorporated P value associated with the first sam- by reference with the approval of the ple is set equal to the CUSUM incre- Director of the Federal Register in ac- ment for that sample.] cordance with 5 U.S.C. 552(a) and 1 CFR (iii) Evaluate the new CUSUM–P part 51. value. The new CUSUM–P value must (ix) Demonstrate that acceptable not exceed 5.2. limits of systematic laboratory dif- (2) Negative systematic laboratory difference, variability, and individual ference: The standardized difference be- large deviations are being maintained tween the accredited laboratory’s rein the analyses of moisture, protein, sult and that of the FSIS laboratory fat, and salt content. An accredited for each split or interlaboratory ac- laboratory will successfully dem- creditation maintenance check sample onstrate the maintenance of these ca- is used to determine a CUSUM value, pabilities if its moisture, protein, fat, designated as CUSUM–N. This value is and salt results from interlaboratory computed and evaluated as follows: accreditation maintenance check sam- (i) Determine the CUSUM increment ples and/or split samples satisfy the for the sample. The CUSUM increment criteria presented in this paragraph is set equal to: (b)(3)(ix).5 (A) Systematic laboratory difference— 2.0, if the standardized difference is greater (1) Positive systematic laboratory dif- than 1.6, ference: The standardized difference be- ¥2.0, if the standardized difference is less tween the accredited laboratory’s re- than ¥2.4, sult and that of the FSIS laboratory or for each split or interlaboratory ac- the standardized difference plus 0.4, if the creditation maintenance check sample standardized difference lies between ¥2.4 is used to determine a CUSUM value, and 1.6, inclusive. designated as CUSUM–P. This value is (ii) Compute the new CUSUM–N computed and evaluated as follows: value. The new CUSUM–N value is ob- (i) Determine the CUSUM increment tained by subtracting, algebraically, for the sample. The CUSUM increment the CUSUM increment to the last pre- is set equal to: viously computed CUSUM–N value. If 2.0, if the standardized difference is greater this computation yields a value small- than 2.4, er than 0, the new CUSUM–N value is ¥2.0, if the standardized difference is less set equal to 0. [CUSUM–N values are than ¥1.6, initialized at zero; that is, the CUSUM– or N value associated with the first sam- the standardized difference minus 0.4, if the ple is set equal to the CUSUM incre- standardized difference lies between ¥1.6 ment for that sample.] and 2.4, inclusive. (iii) Evaluate the new CUSUM–N (ii) Compute the new CUSUM–P value. The new CUSUM–N value must value. The new CUSUM–P value is ob- not exceed 5.2. tained by adding, algebraically, the (B) Variability: The absolute value of CUSUM increment to the last pre- the standardized difference between viously computed CUSUM–P value. If the accredited laboratory’s result and that of the FSIS laboratory for each 4 A copy of the ‘‘Official Methods of Analy- split sample or interlaboratory accred- sis of the Association of Analytical Chem- itation maintenance check sample is ists,’’ 15th edition, 1990, is on file with the used to determine a CUSUM value, des- Director, Office of the Federal Register, and ignated as CUSUM–V. This value is may be purchased from the Association of computed and evaluated as follows: Analytical Chemists, Inc., 2200 Wilson Boule- vard, Suite 400, Arlington, Virginia 22201. (1) Determine the CUSUM increment 5 All statistical computations are rounded for the sample. The CUSUM increment to the nearest tenth, except where otherwise is set equal to the larger of ¥0.4 and noted. the absolute value of the standardized

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difference minus 0.9. If this computa- (B) Analyze a set of check samples tion yields a value larger than 1.6, the similar to those used for initial accred- increment is set equal to 1.6. itation, and submit the analytical re- (2) Compute the new CUSUM–V sults to FSIS within 3 weeks of receipt value. The new CUSUM–V value is ob- of the samples. tained by adding, algebraically, the (C) Satisfy criteria for check samples CUSUM increment to the last pre- specified in paragraphs (b)(2)(ii) (A), viously computed CUSUM–V value. If (B), and (C) of this section. this computation yields a value less (xi) Expeditiously report analytical than 0, the new CUSUM–V value is set results of official samples to the FSIS equal to 0. [CUSUM–V values are Eastern Laboratory, College Station initialized at zero; that is, the CUSUM– Road, P.O. Box 6085, Athens, GA 30604, V value associated with the first sam- or to the address designated by the ple is set equal to the CUSUM incre- Quality Systems Branch, FSIS Chem- ment for that sample.] istry Division. The Federal inspector (3) Evaluate the new CUSUM–V at any establishment may assign the value. The new CUSUM–V value must analysis of official samples of an FSIS not exceed 4.3. laboratory if, in the inspector’s judg- (C) Large deviations: The large devi- ment, there are delays in receiving test ation measure of the accredited labora- results on official samples from an ac- tory’s result for each split sample or credited laboratory. interlaboratory accreditation mainte- (xii) Pay the required accreditation nance check sample is used to deter- fee when it is due. mine a CUSUM value, designated as (c) Laboratories accredited for analysis CUSUM–D.6 This value is computed and of a class of chemical residues in poultry evaluated as follows: and poultry products—(1) Applying for (1) Determine the CUSUM increment accreditation. Application for accredita- for the sample. The CUSUM increment tion shall be made on designated forms is set equal to the value of the large de- provided by FSIS, or otherwise in writ- viation measure minus 0.025. ing, by the owner or manager of the (2) Compute the new CUSUM–D non-Federal analytical laboratory and value. The new CUSUM–D value is ob- sent to the Accredited Laboratory Pro- tained by adding, algebraically, the gram, room 516–A, Annex Building, CUSUM increment to the last pre- Food Safety and Inspection Service, viously computed CUSUM–D value. If U.S. Department of Agriculture, 300 this computation yields a value less 12th Street, SW., Washington, DC than 0, the new CUSUM–D value is set 20250–3700, and shall specify the kinds equal to 0. [CUSUM–D values are of accreditation that are wanted by the initialized at zero; that is, the CUSUM– owner or manager of the laboratory. A D value associated with the first sam- laboratory whose accreditation has ple is set equal to the CUSUM incre- been refused or revoked may reapply ment for that sample.] for accreditation after 60 days from the effective date of that action, and must (3) Evaluate the new CUSUM–D provide written documentation specify- value. The new CUSUM–D value must ing what corrections were made. not exceed 1.0. (i) At the time that an Application (x) Meet the following requirements for Accreditation is filed with the Ac- if placed on probation pursuant to credited Laboratory Program, FSIS, paragraph (e) of this section: and annually thereafter upon receipt of (A) Send all official samples that the bill issued by FSIS on the anniver- have not been analyzed as of the date sary date of each accreditation, the of written notification of probation to management of a laboratory shall re- a specified FSIS laboratory by certified imburse the program at the rate speci- mail or private carrier or, as an alter- fied in 9 CFR 391.5 for the cost of each native, to an accredited laboratory ap- accreditation that is sought by the lab- proved for food chemistry. Mailing ex- oratory or that the laboratory holds. penses will be paid by FSIS. (ii) Simultaneously with the initial application for accreditation, the man- 6 See footnote 3. agement of a laboratory shall forward

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a check, bank draft, or money order in quirements presented below. This ac- the amount specified in 9 CFR 391.5 creditation authorizes official FSIS ac- made payable to the U.S. Department ceptance of the analytical test results of Agriculture along with the com- provided by these laboratories on offi- pleted application for the accredita- cial samples. To obtain FSIS accreditation(s) sought by the laboratory. Ac- tion for the analysis of a class of chem- creditation will not be granted or con- ical residues, a non-Federal analytical tinued, without further procedure, for laboratory must: failure to pay the accreditation fee(s). (i) Be supervised by a person holding, The fee(s) paid shall be nonrefundable as a minimum, a bachelor’s degree in and shall be credited to the account either chemistry, food science, food from which the expenses of the labora- technology, or a related field and ei- tory accreditation program are paid. ther the supervisor or the analyst as- (iii) Annually on the anniversary signed to analyze the sample has 3 date of each accreditation, FSIS will years’ experience determining analytes issue a bill in the amount specified in at or below part per million levels, or 9 CFR 391.5. equivalent qualifications, as deter- (iv) Bills are payable upon receipt by mined by the Administrator. check, bank draft, or money order (ii) Demonstrate acceptable limits of made payable to the U.S. Department systematic laboratory difference, vari- of Agriculture and become delinquent ability, individual large deviations, re- 30 days from the date of the bill. Ac- coveries, and proper identification in creditation will be terminated without the analysis of the class of chemical further procedure for having a delin- residues for which application was quent account. The fee(s) paid shall be made, using FSIS approved procedures. nonrefundable and shall be credited to An applying laboratory will success- the account from which the expenses of fully demonstrate these capabilities if the Accredited Laboratory Program its analytical results for each specific are paid. chemical residue provided in a check (v) The accreditation of a laboratory sample accreditation study containing that was accredited by FSIS on or be- a minimum of 14 samples satisfy the fore December 13, 1993 and was not on criteria presented in this paragraph probation and whose accreditation on (c)(2)(ii).7 In addition, if the laboratory that date was not in suspension or rev- is requesting accreditation for the ocation shall be continued, provided analysis of chlorinated hydrocarbons, that such laboratory reapply for ac- all analytical results for the residue creditation in accordance with the pro- class must collectively satisfy the cri- visions of this paragraph (c)(1) by Jan- teria. [Conformance to criteria (c)(2)(ii) uary 12, 1994 (30 days of the effective (A), (B), (C), (D), (E), and (F) of this date of this section), and that the re- section will only be determined when application be accepted by the Agency. six or more analytical results with as- The CUSUM values for such laboratory sociated comparison means at or above will be reset at zero upon acceptance of the logarithm of the minimum pro- its reapplication. The accreditation of ficiency level are available.] If the re- a laboratory that is on probation shall sults of the first set of check samples be continued, provided that the labora- do not meet these criteria for obtain- tory reapply for accreditation by Feb- ing accreditation, a second set of at ruary 11, 1994 (60 days of the effective least 14 samples will be provided within date of this section), that the re- 30 days following the date of receipt by application be accepted by the Agency, FSIS of a request from the applying and that the laboratory satisfy the laboratory. If the results of the second terms of the probation. set of samples do not meet accredita- (2) Criteria for obtaining accreditation. tion criteria, the laboratory may re- Non-Federal analytical laboratories apply after a 60-day waiting period, may be accredited for the analysis of a commencing from the date of refusal of class of chemical residues in poultry accreditation by FSIS. At that time, a and poultry products. Accreditation will be given only if the applying lab- 7 All statistical computations are rounded oratory successfully satisfies the re- to the nearest tenth, unless otherwise noted.

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new application, all fees, and all docu- that samples have been analyzed under mentation of corrective action re- this Program. quired for accreditation must be sub- (iii) Maintain complete records of the mitted. receipt, analysis, and disposition of of- (A) Systematic laboratory difference: ficial samples for the most recent 3 The absolute value of the average years that samples have been analyzed standardized difference must not ex- under the Program. ceed 1.67 (2.00 if there are less than 12 (iv) Maintain a standards book, analytical results) minus the product which is a permanently bound book of 0.29 and the standard deviation of with sequentially numbered pages, con- the standardized differences. taining all readings and calculations (B) Variability: The standard devi- for standardization of solutions, deter- ation of the standardized differences must not exceed a computed limit. mination of recoveries, and calibration This limit is a function of the number of instruments. All entries are to be of analytical results used in the com- dated and signed by the analyst imme- putation of the standard deviation, and diately upon completion of the entry of the amount of variability associated and by his/her supervisor within 2 with the results from the participating working days. The standards book is to FSIS laboratories. be retained for a period of 3 years after (C) Individual large deviations: One the last entry is made. hundred times the average of the large (v) Analyze interlaboratory accredi- deviation measures of the individual tation maintenance check samples and analytical results must be less than return the results to FSIS within 3 5.0.8 weeks of sample receipt. This must be (D) QA recovery: The average of the done whenever requested by FSIS and QA recoveries of the individual analyt- at no cost to FSIS. ical results must lie within the range (vi) Inform the Accredited Labora- given in Table 2 under the column enti- tory Program, Room 516–A, Annex tled ‘‘Percent Expected Recovery.’’ Building, Food Safety and Inspection (E) QC recovery: All QC recoveries Service, U.S. Department of Agri- must lie within the range given in culture, 300 12th Street, SW., Washing- Table 2 under ‘‘Percent Expected Re- ton, DC 20250–3700, by certified or reg- covery.’’ Supporting documentation istered mail, within 30 days when there must be made available to FSIS upon request. is any change in the laboratory’s own- (F) Correct identification: There must ership, officers, directors, supervisory be correct identification of all chemi- personnel, or any other responsibly cal residues in all samples. connected individual or entity. (iii) Allow inspection of the labora- (vii) Permit any duly authorized rep- tory by FSIS officials prior to the de- resentative of the Secretary to perform termination of granting accredited sta- both announced and unannounced on- tus. site laboratory reviews of facilities and (iv) Pay the accreditation fee by the records during normal business hours, date required. and to copy any records pertaining to (3) Criteria for maintaining accredita- the laboratory’s participation in the tion. To maintain accreditation for Accredited Laboratory Program. analysis of a class of chemical residues, (viii) Use analytical procedures des- a non-Federal analytical laboratory ignated and approved by FSIS. must: (ix) Demonstrate that acceptable (i) [Reserved] limits of systematic laboratory dif- (ii) Maintain laboratory quality conference, variability, and individual trol records for the most recent 3 years large deviations are being maintained in the analysis of samples, in the chem- 8 A result will have a large deviation meas- ical residue class for which accredita- ure equal to zero when the absolute value of tion was granted. A laboratory will the result’s standardized difference, (d), is less than 2.5, and otherwise a measure equal to 1–(2.5/d)4.

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successfully demonstrate the mainte- viously computed CUSUM–P value. If nance of these capabilities if its ana- this computation yields a value small- lytical results for each specific chemi- er than 0, the new CUSUM–P value is cal residue found in interlaboratory ac- set equal to 0. [CUSUM–P values are creditation maintenance check sam- initialized at zero; that is, the CUSUM– ples and/or split samples satisfy the P value associated with the first sam- 9 10 criteria presented below. In addi- ple is set equal to the CUSUM incre- tion, if the laboratory is accredited for ment for that sample.] the analysis of chlorinated hydro- (iii) Evaluate the new CUSUM–P carbons, all analytical results for the residue class must collectively satisfy value. The new CUSUM–P value must the criteria. not exceed 4.8. (A) Systematic laboratory difference: (2) Negative systematic laboratory dif- (1) Positive systematic laboratory difference: The standardized difference be- ference: The standardized difference between the accredited laboratory’s re- tween the accredited laboratory’s result and that of the FSIS laboratory sult and that of the FSIS laboratory for each split and/or interlaboratory for each split and/or interlaboratory accreditation maintenance check sam- accreditation maintenance check sample is used to determine a CUSUM ple is used to determine a CUSUM value, designated as CUSUM–N.12 This value, designated as CUSUM–P.11 This value is computed and evaluated as fol- value is computed and evaluated as follows: lows: (i) Determine the CUSUM increment (i) Determine the CUSUM increment for the sample. The CUSUM increment for the sample. The CUSUM increment is set equal to: is set equal to: 2.0, if the standardized difference is greater 2.0, if the standardized difference is greater than 1.5, than 2.5, ¥2.0, if the standardized difference is less ¥2.0, if the standardized difference is less than ¥1.5, than ¥2.5, or or the standardized difference minus 0.5, if the the standardized difference plus 0.5, if the standardized difference lies between ¥1.5 standardized difference lies between ¥2.5 and 2.5, inclusive. and 1.5, inclusive. (ii) Compute the new CUSUM–P (ii) Compute the new CUSUM–N value. The new CUSUM–P value is ob- value. The new CUSUM–N value is obtained by adding, algebraically, the tained by subtracting, algebraically, CUSUM increment to the last pre- the CUSUM increment to the last previously computed CUSUM–N value. If 9 All statistical computations are rounded this computation yields a value small- to the nearest tenth, except where otherwise er than 0, the new CUSUM–N value is noted. 10 An analytical result will only be used in set equal to 0. [CUSUM–N values are the statistical evaluation of the laboratory if initialized at zero; that is, the CUSUM– the associated comparison mean is equal to N value associated with the first sam- or greater than the logarithm of the mini- ple is set equal to the CUSUM incre- mum proficiency level for the residue. ment for that sample.] 11 When determining compliance with this (iii) Evaluate the new CUSUM–N criterion for all chlorinated hydrocarbon results in a sample collectively, the following value. The new CUSUM–N value must statistical procedure must be followed to ac- not exceed 4.8. count for the correlation of analytical re- (B) Variability: The absolute value of sults within a sample: the average of the the standardized difference between standardized differences of the analytical re- the accredited laboratory’s result and sults within the sample, divided by a constant, is used in place of a single standard- that of the FSIS laboratory for each ized difference to determine the CUSUM–P split and/or interlaboratory accredita- (or CUSUM–N) value for the sample. The tion maintenance check sample is used constant is a function of the number of analytical results used to compute the average standardized difference. 12 See footnote 11.

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to determine a CUSUM value, des- puted CUSUM–D value. If this com- ignated as CUSUM–V.13 This value is putation yields a value less than 0, the computed and evaluated as follows: new CUSUM–D value is set equal to 0. (1) Determine the CUSUM increment [CUSUM–D values are initialized at for the sample. The CUSUM increment zero; that is, the CUSUM–D value asso- is set equal to the larger of ¥0.4 and ciated with the first sample is set equal the absolute value of the standardized to the CUSUM increment for that sam- difference minus 0.9. If this computa- ple.] tion yields a value larger than 1.6, the (3) Evaluate the new CUSUM–D increment is set equal to 1.6. value. The new CUSUM–D value must (2) Compute the new CUSUM–V not exceed 1.0. value. The new CUSUM–V value is ob- (x) Meet the following requirements tained by adding, algebraically, the if placed on probation pursuant to CUSUM increment to the last pre- paragraph (e) of this section: viously computed CUSUM–V value. If (A) Send all official samples that this computation yields a value less have not been analyzed as of the date than 0, the new CUSUM–V value is set of written notification of probation to equal to 0. [CUSUM–V values are a specified FSIS Science Laboratory by initialized at zero; that is, the CUSUM– certified mail or private carrier or, as V value associated with the first sam- an alternative, to an accredited labora- ple is set equal to the CUSUM incre- tory accredited for this specific chemi- ment for that sample.] cal residue. Mailing expenses will be (3) Evaluate the new CUSUM–V paid by FSIS. value. The new CUSUM–V value must (B) Analyze a set of check samples not exceed 4.3. similar to those used for initial accred- (C) Large Deviations: The large devi- itation, and submit analytical results ation measure of the accredited labora- to FSIS within 3 weeks of receipt of tory’s result for each split and/or inter- the samples. laboratory accreditation maintenance (C) Satisfy criteria for check samples check sample is used to determine a as specified in paragraphs (c)(2)(ii) (A), CUSUM value, designated as CUSUM– (B), (C), (D), (E), and (F) of this section D.14 This value is computed and evalu- (xi) Expeditiously report analytical ated as follows: results of official samples to the FSIS (1) Determine the CUSUM increment Eastern Laboratory, College Station for the sample. The CUSUM increment Road, P.O. Box 6085, Athens, GA 30604, is set equal to the large deviation or to the address designated by the measure minus 0.025. Quality Systems Branch, FSIS Chem- (2) Compute the new CUSUM–D istry Division. The Federal inspector value. The new CUSUM–D is obtained at any establishment may assign the by adding, algebraically, the CUSUM analysis of official samples to an FSIS increment to the last previously com- laboratory if, in the judgment of the inspector, there are delays in receiving 13 When determining compliance with this test results on official samples from an criterion for all chlorinated hydrocarbon re- accredited laboratory. sults in a sample collectively, the following (xii) Every QC recovery associated statistical procedure must be followed to ac- with reporting of official samples must count for the correlation of analytical re- be within the appropriate range given sults within a sample: the square root of the sum of the within sample variance and the in Table 2 under ‘‘Percent Expected Re- average standardized difference of the sam- covery.’’ Supporting documentation ple, divided by a constant, is used in place of must be made available to FSIS upon the absolute value of the standardized dif- request. ference to determine the CUSUM–V value for (xiii) Demonstrate that acceptable the sample. The constant is a function of the levels of systematic laboratory dif- number of analytical results used to com- ference, variability, individual large pute the average standardized difference. deviations, recoveries, and proper iden- 14 A result will have a large deviation measure equal to zero when the absolute tification are being maintained in the value of the result’s standardized difference, analysis of interlaboratory accredita- (d), is less than 2.5, and otherwise a measure tion maintenance check samples, in equal to 1¥(2.5/d)4. the chemical residue class for which

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accreditation was granted. A labora- CUSUM–N.16 This value is computed tory will successfully demonstrate the and evaluated as follows: maintenance of these capabilities if its (i) Determine the CUSUM increment analytical results for each specific for the sample. The CUSUM increment chemical residue found in interlabora- is set equal to: tory accreditation maintenance check 2.0, if the standardized difference is greater samples satisfy the criteria presented than 1.5, below. In addition, if the laboratory is ¥2.0, if the standardized difference is less accredited for the analysis of than ¥2.5, chlorinated hydrocarbons, all analyt- or ical results for the residue class must the standardized difference plus 0.5, if the collectively satisfy the criteria. standardized difference lies between ¥2.5 (A) Systematic laboratory difference— and 1.5, inclusive. (1) Positive systematic laboratory dif- (ii) Compute the new CUSUM–N ference: The standardized difference be- value. The new CUSUM–N value is ob- tween the accredited laboratory’s retained by subtracting, algebraically, sult and the comparison mean for each the CUSUM increment to the last pre- interlaboratory accreditation mainte- viously computed CUSUM–N value. If nance check sample is used to deter- this computation yields a value small- mine a CUSUM value, designated as er than 0, the new CUSUM–N value is CUSUM–P.15 This value is computed set equal to 0. [CUSUM–N values are and evaluated as follows: initialized at zero; that is, the CUSUM– (i) Determine the CUSUM increment N value associated with the first sam- for the sample. The CUSUM increment ple is set equal to the CUSUM incre- is set equal to: ment for that sample.] (iii) Evaluate the new CUSUM–N 2.0, if the standardized difference is greater value. The new CUSUM–N value must than 2.5, not exceed 4.8. ¥2.0, if the standardized difference is less (B) Variability: The absolute value of than ¥1.5, the standardized difference between or the accredited laboratory’s result and the standardized difference minus 0.5, if the the comparison mean for each interlab- standardized difference lies between ¥1.5 oratory accreditation maintenance and 2.5, inclusive. check sample is used to determine a (ii) Compute the new CUSUM–P CUSUM value, designated as CUSUM– 17 value. The new CUSUM–P value is ob- V. This value is computed and evalu- tained by adding, algebraically, the ated as follows: ( ) Determine the CUSUM increment CUSUM increment to the last pre- 1 for the sample. The CUSUM increment viously computed CUSUM–P value. If is set equal to the larger of 0.4 or the this computation yields a value small- ¥ absolute value of the standardized dif- er than 0, the new CUSUM–P value is ference minus 0.9. If this computation set equal to 0. [CUSUM–P values are yields a value larger than 1.6, the in- initialized at zero; that is, the CUSUM– crement is set equal to 1.6. P value associated with the first sam- (2) Compute the new CUSUM–V ple is set equal to the CUSUM incre- value. The new CUSUM–V value is ob- ment for that sample.] tained by adding, algebraically, the (iii) Evaluate the new CUSUM–P CUSUM increment to the last pre- value. The new CUSUM–P value must viously computed CUSUM–V value. If not exceed 4.8. this computation yields a value less (2) Negative systematic laboratory dif- than 0, the new CUSUM–V value is set ference: The standardized difference be- equal to 0. [CUSUM–V values are tween the accredited laboratory’s re- initialized at zero; that is, the CUSUM– sult and the comparison mean for each V value associated with the first sam- interlaboratory accreditation mainte- ple is set equal to the CUSUM incre- nance check sample is used to deter- ment for that sample.] mine a CUSUM value, designated as 16 See footnote 11. 15 See footnote 11. 17 See footnote 13.

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(3) Evaluate the new CUSUM–V sis for failure to meet the requirements value. The new CUSUM–V value must of paragraph (c)(1) or (c)(2) of this sec- not exceed 4.3. tion. (C) Large deviations: The large devi- (3) A laboratory shall be refused sub- ation measure of the accredited labora- sequent accreditation for failure to re- tory’s result for each interlaboratory turn to an FSIS laboratory, by cer- accreditation maintenance check sam- tified mail or private carrier, all offi- ple is used to determine a CUSUM cial samples which have not been ana- value, designated as CUSUM–D.18 This lyzed as of the notification of a loss of value is computed and evaluated as fol- accreditation. lows: (4) A laboratory shall be refused ac- (1) Determine the CUSUM increment creditation if the applicant or any indi- for the sample. The CUSUM increment vidual or entity responsibly connected is set equal to the value of the large de- with the applicant has been convicted viation measure minus 0.025. of or is under indictment or if charges (2) Compute the new CUSUM–D value on an information have been brought The new CUSUM–D is obtained by add- against the applicant or responsibly ing, algebraically, the CUSUM incre- connected individual or entity in any ment to the last previously computed Federal or State court concerning the CUSUM–D value. If this computation following violations of law: yields a value less than 0, the new (i) Any felony. CUSUM–D value is set equal to 0. (ii) Any misdemeanor based upon ac- [CUSUM–D values are initialized at quiring, handling, or distributing of zero; that is, the CUSUM–D value asso- unwholesome, misbranded, or decep- ciated with the first sample is set equal tively packaged food or upon fraud in to the CUSUM increment for that sam- connection with transactions in food. ple.] (iii) Any misdemeanor based upon a (3) Evaluate the new CUSUM–D false statement to any governmental value. The new CUSUM–D value must agency. not exceed 1.0. (iv) Any misdemeanor based upon the (D) Each QC Recovery is within the offering, giving or receiving of a bribe range given in Table 2 under ‘‘Percent or unlawful gratuity. Expected Recovery’’. Supporting docu- (e) Probation of accreditation. Upon a mentation must be made available to determination by the Administrator, a FSIS upon request. laboratory shall be placed on probation (E) Not more than 1 residue for the following reasons: misidentification in any 2 consecutive (1) If the laboratory fails to complete check samples. more than one interlaboratory accredi- (F) Not more than 2 residue tation maintenance check sample anal- misidentifications in any 8 consecutive ysis within 12 consecutive months as check samples. required by paragraphs (b)(3)(v) and (xiv) Pay the accreditation fee when it is due. (c)(3)(v) of this section, unless written (d) Refusal of accreditation. Upon a de- permission is granted by the Adminis- termination by the Administrator, a trator to exceed the time limit. laboratory will be refused accredita- (2) If the laboratory fails to meet any tion for the following reasons: of the criteria set forth in paragraphs (1) A laboratory shall be refused ac- (b)(3)(v) and (b)(3)(ix) and (c)(3)(v) and creditation for moisture, protein, fat, (c)(3)(ix) of this section. and salt analysis for failure to meet (f) Suspension of accreditation. The ac- the requirements of paragraph (b)(1) or creditation of a laboratory shall be sus- (b)(2) of this section. pended if the laboratory or any individ- (2) A laboratory shall be refused ac- ual or entity responsibly connected creditation for chemical residue analy- with the laboratory is indicted or if charges on an information have been brought against the laboratory or re- 18 A result will have a large deviation measure equal to zero when the absolute sponsibly connected individual or en- value of the result’s standardized difference, tity in any Federal or State court con- (d), is less than 2.5, and otherwise a measure cerning any of the following violations equal to 1¥(2.5/d)4. of law:

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(1) Any felony. (3) An accredited laboratory shall (2) Any misdemeanor based upon ac- have its accreditation revoked if the quiring, handling or distributing of un- Administrator determines that the lab- wholesome, misbranded, or deceptively oratory or any responsibly connected packaged food or upon fraud in connec- individual or any agent or employee tion with transactions in food. has: (3) Any misdemeanor based upon a (i) Altered any official sample or ana- false statement to any governmental lytical finding, or, agency. (ii) Substituted any analytical result (4) Any misdemeanor based upon the from any other laboratory for its own. offering, giving or receiving of a bribe or unlawful gratuity. (4) An accredited laboratory shall (g) Revocation of accreditation. The ac- have its accreditation revoked if the creditation of a laboratory shall be re- laboratory or any individual or entity voked for the following reasons: responsibly connected with the labora- (1) An accredited laboratory which is tory is convicted in a Federal or State accredited to perform analysis under court of any of the following violations paragraph (b) of this section shall have of law: its accreditation revoked for failure to (i) Any felony. meet any of the requirements of para- (ii) Any misdemeanor based upon ac- graph (b)(3) except for the following quiring, handling, or distributing of circumstances. If the accredited lab- unwholesome, misbranded, or decep- oratory fails to meet the criteria for tively packaged food or upon fraud in reporting the analytical results on connection with transactions in food. interlaboratory accreditation mainte- (iii) Any misdemeanor based upon a nance check samples as set forth in false statement to any governmental paragraph (b)(3)(v) of this section or if, agency. at any time, the CUSUM results from (iv) Any misdemeanor based upon the the analysis of such interlaboratory ac- offering, giving or receiving of a bribe creditation maintenance check sam- or unlawful gratuity. ples and/or split samples have not satisfied the criteria specified in para- (h) Notification and hearings. Accredi- graph (b)(3)(ix) of this section and tation of any laboratory shall be re- there have been, during the previous 12 fused, suspended, or revoked under the months, no other occasions on which conditions previously described herein. such CUSUM results have not satisfied The owner or operator of the labora- such criteria, the laboratory shall be tory shall be sent written notice of the placed on probation; but if there have refusal, suspension, or revocation of ac- been such other occasions during those creditation by the Administrator. In 12 months, the laboratory’s accredita- such cases, the laboratory owner or option will be revoked. erator will be provided an opportunity (2) An accredited laboratory which is to present, within 30 days of the date of accredited to perform analysis for a the notification, a statement challeng- class of chemical residues under para- ing the merits or validity of such ac- graph (c) of this section shall have the tion and to request an oral hearing accreditation to perform this analysis with respect to the denial, suspension, revoked if it fails to meet any of the or revocation decision. An oral hearing requirements in paragraph (c)(3) of this shall be granted if there is any dispute section except for the following cir- of material fact joined in such respon- cumstances. If the accredited labora- sive statement. The proceeding shall tory fails to meet any of the criteria thereafter be conducted in accordance set forth in paragraphs (c)(3)(v), with the applicable rules of practice (c)(3)(ix), and (c)(3)(xiii) of this section and it has not so failed during the 12 which shall be adopted for the proceed- months preceding its failure to meet ing. Any such refusal, suspension, or the criteria, it shall be placed on pro- revocation shall be effective upon the bation, but if it has so failed at any receipt by the laboratory of the notifi- time during those 12 months, its ac- cation and shall continue in effect creditation will be revoked.

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until final determination of the matter shall be so processed as to raise the sol- by the Administrator. ids content, excluding salt, to 34 per- (Reporting and recordkeeping requirements cent. The official establishment shall approved by the Office of Management and furnish adequate facilities for such Budget under control number 0583–0015) testing. [52 FR 2192, Jan. 20, 1987, as amended at 58 FR 65264, 65266–65268, Dec. 13, 1993; 59 FR § 381.156 Poultry meat content stand- 33642, 33643, June 30, 1994; 59 FR 66448, Dec. 27, ards for certain poultry products. 1994; 60 FR 10305, Feb. 24, 1995] Poultry products with labeling terminology as set forth in Table I shall Subpart P—Definitions and Stand- comply with the specifications for per- ards of Identity or Composi- cent light meat and percent dark meat tion set forth in said table.

§ 381.155 General. TABLE I (a) Authorization to establish specifica- Percent light Percent dark tions. (1) The Administrator is author- Label terminology meat meat ized to establish specifications or definitions and standards of identity or Natural proportions ...... 50±65 ...... 50±35. composition, covering the principal Light or white meat ...... 100 ...... 0. constituents of any poultry product Dark meat ...... 0 ...... 100. Light and dark meat ..... 51±65 ...... 49±35. with respect to which a specified name Dark and light meat ..... 35±49 ...... 65±51. of the product or other labeling termi- Mostly white meat ...... 66 or more ...... 34 or less. nology may be used, whenever he de- Mostly dark meat ...... 34 or less ...... 66 or more. termines such action is necessary to prevent sale of the product under false [37 FR 9706, May 16, 1972, as amended at 39 or misleading labeling. Further, the FR 4569, Feb. 5, 1974] Administrator is authorized to prescribe definitions and standards of § 381.157 Canned boned poultry and identity or composition for poultry baby or geriatric food. products whenever he determines such (a) Canned boned poultry shall, un- action is otherwise necessary for the less otherwise specified in this section, protection of the public. The require- be prepared from cooked deboned poul- ments of this subpart are hereby found try meat and may contain skin and fat to be necessary for these purposes and not in excess of natural whole carcass standards are hereby established as set proportions. Gelatin, stabilizers, or forth in this subpart. similar solidifying or emulsifying (2) Where cooked poultry meat is agents shall not be added to product la- specified in this subpart as an ingredi- beled ‘‘Boned (Kind)—Solid Pack,’’ but ent of poultry products, this means may be added in quantities not in ex- poultry meat derived from poultry cess of a total of 0.5 percent of the processed, cooked, and cooled in a man- total ingredients in the preparation of ner approved by the Administrator in specific cases without use of liquid or other canned boned poultry products moisture in direct contact with the and in such cases the common name of poultry meat following the cooking the substance shall be included in the and cooling of the poultry. name of the product, e.g., ‘‘Boned (3) If, following cooking and cooling Chicken with Broth—Gelatin Added.’’ of poultry meat to be used in poultry (b) Canned boned poultry, except products, liquid or moisture is used in poultry within paragraph (c) of this direct contact with such poultry meat section, shall meet the requirements and the percentage of solids, excluding set forth in Table II. The percentages salt, in the poultry meat is found to be in Table II shall be calculated on the below 34 percent when such poultry basis of the total ingredients used in meat is tested by acceptable methods, the preparation of the product. the percentage of poultry meat re- (c) Canned boned poultry with natu- quired by this section for any poultry ral juices (Boned (Kind) with natural product shall be increased in propor- juices) shall be prepared from either tion to the deficiency, or the meat raw boned poultry or a mixture of raw

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boned poultry and cooked boned poul- 2 Alternatively, product may be prepared from raw boned poultry meat in combination with cooked bone poultry meat so try and shall have no liquid added dur- long as the product complies with the specified standard. ing the preparation of the product. 3 Label must indicate in some manner that product is for infant or geriatric servings. (d) Canned shredded poultry (Shred- ded Kind), consists of poultry meat re- [37 FR 9706, May 16, 1972, as amended at 39 duced to a shredded appearance, from FR 4569, Feb. 5, 1974] the kind of poultry indicated, with § 381.158 Poultry dinners (frozen) and meat, skin, and fat not in excess of the pies. natural whole carcass proportions. Poultry dinners (frozen) and pies Canned shredded poultry from specific shall meet the requirements set forth parts may include skin or fat in excess in Table III of this section and the per- of the proportions normally found on a centage or weight specified therein whole carcass, but not in excess of the shall be calculated on the basis of total proportions of skin and fat normal to ingredients used in the preparation of the particular part or parts; and such the poultry product. product shall be labeled in accordance with § 381.117(d). TABLE III (e) Canned boned poultry shall be prepared as set forth in Table II, items Minimum cooked Minimum raw deboned poultry deboned poultry 1, 2, 3, or 4, whichever is applicable. meat of kind indi- meat of kind indicated cated TABLE II Per- Per- cent Weight cent Weight Minimum percent (Kind) Pies ...... 14 or 11¤8 oz. 25 or 2 oz. cooked, Maximum per 8-oz. per 8-oz. deboned 1 1 poultry meat percent liq- pie pie. Product name of kind indi- uid that (Kind) Dinners ...... 18 or 2 oz.2, 3 cated, with may be added 1 1 14 percent or 11⁄8 oz., whichever is greater; or 25 skin, fat, percent or 2 oz., whichever is greater. and season- 2 Excluding weight of appetizers, desserts, etc. ing 3 18 percent or 2 oz., whichever is greater. A minimum of 45 percent, or 5 ounces per dinner, whichever is greater, of 1. Boned (Kind)Ðsolid pack ...... 95 5 cooked poultry including bone and breading may be used in 2. Boned (Kind) ...... 90 10 lieu of minimum 18 percent or 2 ounces of cooked deboned 3. Boned (Kind) with broth 2 ...... 80 20 poultry meat and the cooked poultry including bone and 4. Boned (Kind) (ÐÐ) percent breading shall not contain more than 30 percent breading. broth 2, 3 ...... 50 50 § 381.159 Poultry rolls. 1 Liquid may be in the form of, but is not limited to, broth or extractives. (a) Binders or extenders may be 2 Alternatively, product may be prepared from raw boned poultry in combination with cooked boned poultry so long as added in accordance with § 381.147(f)(4) the product complies with the specified standard. of this part. When binding agents are 3 Total amount of liquid added shall be included in the name of the product; e.g., ``Boned Chicken with 25 percent broth.'' added in excess of 3 percent for cooked rolls and 2 percent for raw rolls, the (f) Poultry products intended for in- common name of the agent or the term fant or geriatric use and represented as ‘‘Binders Added’’ shall be included in having a ‘‘high meat’’ content shall the name of the product; e.g., ‘‘Turkey contain not less than 18.75 percent Roll-Gelatin Added.’’ cooked, deboned poultry meat of the (b) With respect to heat processed kind indicated, with seasoning. rolls, 2 percent or less liquid based on the weight of the finished product TABLE IIa without liquid may remain with or be Minimum returned to product labeled as ‘‘(Kind) percent Maximum Roll.’’ cooked, percent liq- (c) Heat processed rolls which have Product name deboned, uid that poultry meat may be more than 2 percent liquid remaining of kind indi- 1 cated, with added with or returned to the product shall seasoning be labeled as ‘‘(Kind) Roll with Natural Juices.’’ If more than 2 percent of any 1. Strained or chopped (Kind) with broth 2, 3 ...... 43 57 liquid other than natural cookout 2. High meat dinner 3 ...... 18.75 juices is added, the product must be la- 1 Liquid may be in the form of, but not limited to, broth or beled to indicate that fact; e.g., ‘‘Tur- extractives. key Roll with Broth.’’ Liquid shall not

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be returned or added to product within § 381.167 Other poultry dishes and spe- this paragraph graph in excess of the cialty items. amount normally cooked out during Poultry dishes and specialty items preparation. listed in Table IV of this paragraph [37 FR 9706, May 16, 1972, as amended at 55 shall meet the requirements set forth FR 34684, Aug. 24, 1990] in said table, irrespective of the type of packaging, and the percentages in § 381.160 (Kind) burgers; (Kind) pat- Table IV shall be calculated on a ties. ready-to-serve basis, except that soup Such product consists of 100 percent bases in institutional packs which are poultry of the kind indicated, with prepared for sale to institutional users shall have a minimum of 15 percent skin and fat not in excess of natural cooked deboned poultry meat based on proportions. Product containing fillers the weight of the soup base product. or binders shall be named ‘‘(Kind) Pat- ties.’’ TABLE IV

§ 381.161 ‘‘(Kind) A La Kiev.’’ Minimum Minimum percent percent Such product consists of poultry cooked cooked Product name 1 deboned poultry of meat of the kind indicated, stuffed poultry meat kind indi- with butter which may be seasoned and of kind indicated, indi- the product may be wrapped in suffi- cated cating bone cient skin to cover the meat. It may be (Kind) Ravioli ...... 2 ...... dipped in batter, fried, and frozen. (Kind) Soup ...... 2 ...... Chop Suey with (Kind) ...... 2 ...... (Kind) Chop Suey ...... 4 ...... § 381.162 ‘‘(Kind) steak or fillet.’’ (Kind) Chow Mein without noo- Such product consists of a boneless dles ...... 4 ...... (Kind) Tamales ...... 6 ...... slice or strip of poultry meat of the Noodles or Dumplings with kind indicated. (Kind) 2 ...... 6 ...... (Kind) Stew ...... 12 ...... § 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) (Kind) Fricassee of Wings ...... 40 roasted.’’ (Kind) Noodles or Dumplings 2 .. 15 30 (Kind) with Vegetables ...... 15 ...... Such product consists of ready-to- Gravy with sliced (Kind) ...... 15 ...... cook poultry of the kind indicated, (Kind) Tetrazzini ...... 15 ...... (Kind) chili with beans ...... 17 ...... that has been cooked in dry source Creamed (Kind) ...... 20 ...... heat, e.g., oven roasted or oven baked. (Kind) Cacciatore ...... 20 40 (Kind) Fricassee ...... 20 40 § 381.164 ‘‘(Kind) barbecued.’’ (Kind) A-La-King ...... 20 ...... (Kind) croquettes ...... 25 ...... Such product consists of ready-to- Slice (Kind) with Gravy and cook poultry of the kind indicated, Dressing ...... 25 ...... 3 that has been cooked in dry heat and (Kind) Salad ...... 25 ...... (Kind) chili ...... 28 ...... basted with a seasoned sauce. (Kind) Hash ...... 30 ...... Sliced (Kind) with Gravy ...... 35 ...... § 381.165 ‘‘(Kind) barbecued prepared Minced (Kind) Barbecue ...... 40 ...... with moist heat.’’ 1 The product name may contain other appropriate descriptive terms such as ``noodle''; e.g., ``Chicken Noodle Soup.'' Such product consists of ready-to- 2 This standard also applies to products named (Kind) with cook poultry of the kind indicated that rice or similar starches. 3 The 25 percent-standard listed includes poultry meat plus has been cooked by the action of moist proportions of skin and fat natural to the poultry used. heat in a barbecue sauce. [37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974] § 381.166 Breaded products. ‘‘Breaded’’ is a term applicable to § 381.168 Maximum percent of skin in any poultry product which is coated certain poultry products. with breading or a batter and breading The poultry products listed in Table in an amount not to exceed 30 percent V shall have not more than the percent of the weight of the finished breaded of skin specified in the table, when raw product. and when cooked.

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TABLE V same prominence, except that the words which describe the function of Percent skin Product name the added materials (such as ‘‘Injected Raw Cooked for Flavored Basting’’) may be more prominent, provided this does not de- Boneless Turkey Breast or tract from the conspicuousness of the Boneless Turkey Breast Roll ...... 14 other terms in the product name (such Boneless Turkey Thigh as ‘‘Young Turkey’’). The label must or Boneless Turkey Thigh Roll ...... 8 also bear a statement, in bold type, im- Boneless Turkey mediately below and adjacent to the or product name, listing the common or Turkey Roll ...... 15 Boneless Chicken Breast usual names of the added materials in or descending order of predominance. The Boneless Chicken Breast Roll ...... 18 20 first part of this statement must con- Boneless Chicken or sist of terms adequate to inform con- Chicken Roll ...... 20 25 sumers about the amount and manner of introduction of the solution (such as § 381.169 Ready-to-cook poultry prod- ‘‘Injected with approximately 3 percent ucts to which solutions are added. of a solution of —————’’), and must (a) Butter alone, or solutions of poul- be printed at least one-fourth the size try broth, poultry stock, water, or edi- of the most prominent letter in the ble fats, or mixtures thereof, in which product name, with a minimum size of are included functional substances one-fourth inch for a ready-to-cook such as spices, flavor enhancers, emul- turkey and proportionately smaller for sifiers, phosphates, coloring materials, other poultry products. The remainder or other substances, approved by the of the solution ingredients shall be de- Administrator in specific cases, may be clared in type at least one-eighth inch introduced by injection into the thick in height. The entire statement must muscles (breast and legs) of ready-to- be printed in a color that contrasts cook poultry carcasses and may be in- with the background and be displayed troduced by injection or marinating on the principal display panel. into any separate bone-in part there- (c) Approval for use of a label for from, for the purpose of providing a product under this section depends basting medium or similar function. upon the ability of the processor to The ingredients of the added materials control the finished product, within a and the manner of addition to the prod- range of three-tenths of 1 percent accu- ucts must be found acceptable by the racy, so that the average percent of Administrator, in all cases. The intro- basting material in each outgoing lot duction of the added materials shall in- is not greater than 3.3 percent or less crease the weight of the processed than 2.7 percent of basting material product by approximately 3 percent when tested by an approved plant con- over the weight of the raw product trol procedure would be in compliance. after washing and chilling in compli- As used in this section, ‘‘a lot’’ may be ance with § 381.66. The weight of the any reasonable portion of production added materials introduced into the designated by the operator of the offi- poultry products as provided in this cial establishment, with a maximum of paragraph shall be included as part of an entire shift’s production from one the weight of the poultry for purposes production line. The control procedures of the net weight labeling provisions in to be eligible for approval by the Ad- § 381.121(b). ministrator must: (b) A raw poultry product, into which (1) Assure compliance with all label- added materials are introduced as pro- ing requirements. vided in paragraph (a) of this section (2) Control the variability of the must be labeled with a conspicuous, amount of added approved solution legible, and descriptive name, includ- within the limits defined above. ing terms that concisely describe the (3) Provide for the disposition in ac- method of addition and function of the cordance with the regulations of all added material. All major terms in the products not in compliance with this product name must be printed with the section.

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(4) Incorporate a system of raw of age) with meat less tender than that weight identification of a sufficient of a roaster, or roasting chicken and number of poultry and/or poultry parts nonflexible breastbone tip. to allow effective monitoring of the (vii) Cock or rooster. A cock or rooster system by Federal inspectors and offi- is a mature male chicken with coarse cial establishment employees. skin, toughened and darkened meat, [37 FR 9706, May 16, 1972, as amended at 39 and hardened breastbone tip. FR 36000, Oct. 7, 1974] (2) Turkeys—(i) Fryer-roaster turkey. A fryer-roaster turkey is a young imma- § 381.170 Standards for kinds and ture turkey (usually under 16 weeks of classes, and for cuts of raw poultry. age), of either sex, that is tender- (a) The following standards specify meated with soft, pliable, smooth-tex- the various classes of the specified tured skin, and flexible breastbone car- kinds of poultry, and the requirements tilage. for each class: (ii) Young turkey. A young turkey is a (1) Chickens—(i) Rock Cornish game turkey (usually under 8 months of age) hen or Cornish game hen. A Rock Cor- that is tender-meated with soft, pli- nish game hen or Cornish game hen is able, smooth-textured skin, and breast- a young immature chicken (usually 5 bone cartilage that is somewhat less to 6 weeks of age) weighing not more flexible than in a fryer-roaster turkey. than 2 pounds ready-to-cook weight, Sex designation is optional. which was prepared from a Cornish (iii) Yearling turkey. A yearling tur- chicken or the progeny of a Cornish key is a fully matured turkey (usually chicken crossed with another breed of under 15 months of age) that is reason- chicken. ably tender-meated and with reason- (ii) Rock Cornish fryer, roaster, or hen. ably smooth-textured skin. Sex des- A Rock Cornish fryer, roaster, or hen is ignation is optional. the progeny of a cross between a pure- (iv) Mature turkey or old turkey (hen or bred Cornish and a purebred Rock tom). A mature or old turkey is an old chicken, without regard to the weight turkey of either sex (usually in excess of the carcass involved; however, the of 15 months of age) with coarse skin term ‘‘fryer,’’ ‘‘roaster,’’ or ‘‘hen’’ shall and toughened flesh. apply only if the carcasses are from (3) Ducks—(i) Broiler duckling or fryer birds with ages and characteristics duckling. A broiler duckling or fryer that qualify them for such designation duckling is a young duck (usually under paragraph (a)(1) (iii) or (iv) of under 8 weeks of age), of either sex, this section. that is tender-meated and has a soft (iii) Broiler or fryer. A broiler or fryer bill and soft windpipe. is a young chicken (usually under 13 (ii) Roaster duckling. A roaster weeks of age), of either sex, that is ten- duckling is a young duck (usually der-meated with soft, pliable, smooth- under 16 weeks of age), of either sex, textured skin and flexible breastbone that is tender-meated and has a bill cartilage. that is not completely hardened and a (iv) Roaster or roasting chicken. A bird windpipe that is easily dented. of this class is a young chicken (usu- (iii) Mature duck or old duck. A ma- ally 3 to 5 months of age), of either sex, ture duck or an old duck is a duck that is tender-meated with soft, pli- (usually over 6 months of age), of ei- able, smooth-textured skin and breast- ther sex, with toughened flesh, hard- bone cartilage that may be somewhat ened bill, and hardened windpipe. less flexible than that of a broiler or (4) Geese—(i) Young goose. A young fryer. goose may be of either sex, is tender- (v) Capon. A capon is a surgically meated, and has a windpipe that is eas- unsexed male chicken (usually under 8 ily dented. months of age) that is tender-meated (ii) Mature goose or old goose. A ma- with soft, pliable, smooth-textured ture goose or old goose may be of ei- skin. ther sex and has toughened flesh and (vi) Hen, fowl, or baking or stewing. A hardened windpipe. bird of this class is a mature female (5) Guineas—(i) Young guinea. A chicken (usually more than 10 months young guinea may be of either sex, is

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tender-meated, and has a flexible skin shall not be included with the breastbone cartilage. wishbone. (ii) Mature guinea or old guinea. A ma- (4) ‘‘Drumsticks’’ shall be separated ture guinea or an old guinea may be of from the thigh by a cut through the either sex, has toughened flesh, and a knee joint (femorotibial and patellar hardened breastbone. joint) and from the hock joint (tarsal (b) The following standards specify joint). the requirements for the specified cuts (5) ‘‘Thighs’’ shall be disjointed at of poultry: the hip joint and may include the pel- (1) ‘‘Breasts’’ shall be separated from vic meat, but shall not include the pel- the back at the shoulder joint and by a vic bones. Back skin shall not be in- cut running backward and downward cluded. from that point along the junction of (6) ‘‘(Kind) legs’’ shall be the poultry the vertebral and sternal ribs. The ribs product which includes the thigh and may be removed from the breasts, and the drumstick, i.e., the whole leg, and the breasts may be cut along the may include the pelvic meat, but shall breastbone to make two approximately equal halves; or the wishbone portion, not include the pelvic bones. Back skin as described in paragraph (b)(3) of this shall not be included. section, may be removed before cutting (7) ‘‘Wings’’ shall include the entire the remainder along the breastbone to wing with all muscle and skin tissue make three parts. Pieces cut in this intact, except that the wingtip may be manner may be substituted for lighter removed. or heavier pieces for exact weight-mak- (8) ‘‘Backs’’ shall include the pelvic ing purposes and the package may con- bones and all the vertebrae posterior to tain two or more of such parts without the shoulder joint. The meat shall not affecting the appropriateness of the la- be peeled from the pelvic bones. The beling as e.g., ‘‘chicken breasts.’’ Neck vertebral ribs and/or scapula may be skin shall not be included with the removed or included without affecting breasts, except that ‘‘turkey breasts’’ the appropriateness of the name. Skin may include neck skin up to the whisk- shall be substantially intact. er. (9) ‘‘Stripped backs’’ shall include the (2) ‘‘Breasts with ribs’’ shall be sepa- vertebrae from the shoulder joint to rated from the back at the junction of the tail, and include the pelvic bones. the vertebral ribs and back. Breasts The meat may be stripped off of the with ribs may be cut along the breast- pelvic bones. bone to make two approximately equal (10) ‘‘Necks’’, with or without neck halves; or the wishbone portion, as de- skin, shall be separated from the car- scribed in paragraph (b)(3) of this sec- cass at the shoulder joint. tion, may be removed before cutting (11) ‘‘Halves’’ are prepared by making the remainder along the breastbone to a full-length back and breast split of an make three parts. Pieces cut in this eviscerated poultry carcass so as to manner may be substituted for lighter produce approximately equal right and or heavier pieces for exact weight-mak- left sides. ing purposes and the package may contain two or more of such parts without (12) ‘‘Quarters’’ consist of the entire affecting the appropriateness of the la- eviscerated poultry carcass, which has beling as ‘‘breasts with ribs.’’ Neck been cut into four equal parts, but ex- skin shall not be included, except that cluding the neck. ‘‘turkey breasts with ribs’’ may include (13) ‘‘Breast quarter’’ consists of half neck skin up to the whisker. a breast with the wing and a portion of (3) ‘‘Wishbones’’ (Pulley Bones), with the back attached. covering muscle and skin tissue, shall (14) ‘‘Breast quarter without wing’’ be severed from the breast approxi- consists of a front quarter of a poultry mately halfway between the end of the carcass, from which the wing has been wishbone (hypocledium) and front removed. point of the breastbone (cranial process (15) ‘‘Leg quarter’’ consists of a poul- of the sternal crest) to a point where try thigh and drumstick, with a por- the wishbone joins the shoulder. Neck tion of the back attached.

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(16) ‘‘Thigh with back portion’’ con- less than one-eighth inch in height, sists of a poultry thigh with back por- and shall be in the same style and color tion attached. and with the same background as the (17) ‘‘Legs with pelvic bone’’ consists product name. of a poultry leg with adhering meat (f) If the product is fabricated from and skin and pelvic bone. pieces of turkey thigh meat that result (18) ‘‘Wing drummette’’ consists of from the cutting through the muscle the humerus of a poultry wing with ad- (as opposed the whole thighs intact or hering skin and meat attached. whole thighs with some incidental sep- (19) ‘‘Wing portion’’ consists of a aration of muscle tissue during re- poultry wing except that the moval of the bone), the product name drummette has been removed. shall be further qualified by a descrip- (20) ‘‘Cut-up Poultry’’ is any cut-up tive statement. The product name of or disjointed portion of poultry or any product fabricated from such pieces of edible part thereof, as described in this turkey thigh meat equivalent in size to section. a one-half inch cube or greater shall be (21) ‘‘Giblets’’ consist of approxi- further qualified to specify that the mately equal numbers of hearts, giz- product is ‘‘Chunked and Formed.’’ The zards, and livers, as determined on a product name of product fabricated count basis. from such pieces of turkey thigh meat smaller than the equivalent of a one- [37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974] half inch cube shall be further qualified to specify that the product is ‘‘Ground § 381.171 Definition and standard for and Formed’’ or ‘‘Chopped and ‘‘Turkey Ham.’’ Formed’’ as appropriate. The qualify- (a) ‘‘Turkey Ham’’ shall be fabricated ing statement shall immediately follow from boneless, turkey thigh meat with and be contiguous to the statement re- skin and the surface fat attached to quired in paragraph (e) of this section, the skin removed. The thighs shall be and shall be not less than one-half the that cut of poultry described in size of the product name but not less § 381.170(b)(5) of this part. than one-eighth inch in height, and (b) The product may or may not be shall be in the same style and color and smoked, and shall be cured using one with the same background as the prod- or more of the approved curing agents uct name. as provided in § 381.147(f) of this part. [44 FR 51190, Aug. 31, 1979] The product may also contain cure accelerators, phosphates, and flavoring § 381.173 Mechanically Separated agents as provided in § 381.147(f) of this (Kind of Poultry). part; common salt, sugars, spices, spice (a) ‘‘Mechanically Separated (Kind of extractives, dehydrated garlic, and de- Poultry)’’ is any product resulting hydrated onions; and water for purpose from the mechanical separation and re- of dissolving and dispersing the sub- moval of most of the bone from at- stances specified above. tached skeletal muscle and other tissue (c) The cooked finished product of poultry carcasses and parts of car- weight shall be no more than the origi- casses that has a paste-like form and nal weight of the turkey thigh meat consistency, that may or may not con- used prior to curing. tain skin with attached fat and meet- (d) The product name on the label ing the other provisions of this section. shall show the word ‘‘Turkey’’ in the Examples of such product are ‘‘Me- same size, style, color, and with the chanically Separated Chicken’’ and same background as the word ‘‘Ham’’ ‘‘Mechanically Separated Turkey.’’ and shall precede and be adjacent to it. (b) ‘‘Mechanically Separated (Kind of (e) The product name shall be quali- Poultry)’’ shall not have a bone solids fied with the statement ‘‘Cured Turkey content of more than 1 percent. At Thigh Meat.’’ The qualifying statement least 98 percent of the bone particles shall be contiguous to the product present in ‘‘Mechanically Separated name, without intervening type or de- (Kind of Poultry) ‘‘ shall have a maxi- signs, shall be not less than one-half mum size no greater than 1.5 mm (mil- the size of the product name but not limeter) in their greatest dimension

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and there shall be no bone particles Subpart Q—Records, Registration, larger than 2.0 mm in their greatest di- and Reports mension. (c) ‘‘Mechanically Separated (Kind of § 381.175 Records required to be kept. Poultry)’’ shall not have a calcium (a) Every person within any of the content exceeding 0.235 percent when classes specified in paragraph (a) (1), made from mature chickens or from (2), or (3) of this section is required by turkeys as defined in § 381.170(a)(l)(vi) the Act to keep such records as are and (vii) and (a)(2), respectively, or properly necessary for the effective en- 0.175 percent when made from other forcement of the Act: poultry, based on the weight of product (1) Any person that engages in the that has not been heat treated, as a business of slaughtering any poultry or measure of a bone solids content of not processing, freezing, packaging, or la- more than 1 percent. beling any carcasses, or parts or prod- (d) ‘‘Mechanically Separated (Kind of ucts of carcasses, of any poultry, for Poultry)’’ may be used in the formula- commerce, for use as human food or tion of poultry products in accordance animal food; with § 381.174 and meat food products in (2) Any person that engages in the accordance with subchapter A of this business of buying or selling (as a poul- chapter. try products broker, wholesaler, or (e) Product resulting from the me- otherwise) or transporting, in com- chanical separation process that fails merce, or storing in or for commerce, to meet the bone particle size or cal- or importing, any carcasses, or parts or cium content requirements for ‘‘Me- products of carcasses, of any poultry; chanically Separated (Kind of Poul- (3) Any person that engages in busi- try)’’ shall be used only in producing ness, in or for commerce, as a renderer, poultry extractives, including fats, or engages in the business of buying, stocks, and broths and labeled as ‘‘Me- selling, or transporting in commerce, or importing, any dead, dying, dis- chanically Separated (Kind of Poultry) abled, or diseased poultry or parts of for Further Processing.’’ the carcasses of any poultry that died [60 FR 55983, Nov. 3, 1995] otherwise than by slaughter. (b) The required records are: § 381.174 Limitations with respect to (1) Records, such as bills of sale, in- use of Mechanically Separated voices, bills of lading, and receiving (Kind of Poultry). and shipping papers, giving the follow- (a) A poultry product required to be ing information with respect to each prepared from a particular kind of transaction in which any poultry or poultry (e.g., chicken) shall not con- poultry carcass, or part or product of a tain ‘‘Mechanically Separated (Kind of poultry carcass, is purchased, sold, Poultry)’’ described in § 381.173, that is shipped, received, transported, or oth- made from any other kind of poultry erwise handled by said person in con- (e.g., Mechanically Separated Turkey). nection with any business subject to (b) ‘‘Mechanically Separated (Kind of the Act. Poultry)’’ described in § 381.173 may be (i) The name or description of the used in the formulation of any poultry poultry or other articles; or meat food product, provided such (ii) The net weight of the poultry or use conforms with any applicable re- other articles; quirements of the definitions and (iii) The number of outside contain- standards of identity or composition in ers; this subchapter or part 319 of this chap- (iv) The name and address of the ter, and provided that it is identified as buyer of the poultry or other articles ‘‘Mechanically Separated (Kind of sold by such person, and the name and address of the seller of the poultry or Poultry).’’ other articles purchased by such per- [60 FR 55983, Nov. 3, 1995] son;

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(v) The name and address of the con- as required in § 381.307; except that signee or receiver (if other than the records required by § 381.302 (b) and (c) buyer); shall be retained as required by those (vi) The method of shipment; sections. (vii) The date of shipment; and (viii) The name and address of the [37 FR 9706, May 16, 1972, as amended at 51 carrier. FR 45633, Dec. 19, 1986] (2) Guaranties provided by suppliers § 381.178 Access to and inspection of of packaging materials under § 381.144. records, facilities and inventory; (3) Records of canning as required by copying and sampling. subpart X of this part 381, of subchapter C, 9 CFR chapter III. Every person within any of the class- (4) Records of irradiation as required es specified in § 381.175(a) shall, upon by sections 381.149 of this part. the presentation of official credentials (5) Records of nutrition labeling as by any authorized representative of the required by subpart Y of this part. Secretary, during ordinary business (6) Records of all labeling, along with hours, permit such representative to the product formulation and processing enter his or its place of business and procedures, as prescribed in §§ 381.132 examine the records required to be and 381.133. kept by § 381.175(b) and the facilities and inventory pertaining to the busi- (Approved by the Office of Management and ness of such person subject to the Act, Budget under control number 0583–0015) and to copy all such records, and to [37 FR 9706, May 16, 1972, as amended at 47 take reasonable samples of the inven- FR 746, Jan. 7, 1982; 49 FR 2236, Jan. 19, 1984; tory upon payment of the fair market 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. 21, 1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, value therefor. Any necessary facilities Dec. 29, 1995] (other than reproduction equipment) for such examination and copying of § 381.176 Place of maintenance of records and for such examination and records. sampling of inventory shall be afforded Every person engaged in any business to such authorized representative of described in § 381.175(a) shall maintain the Secretary. the records required by § 381.175 at the place of business where such business is § 381.179 Registration. conducted, except that, if such person (a) Except as provided in paragraph conducts such business at multiple lo- (c) of this section, every person that cations, he may maintain such records engages in business, in or for com- at his headquarters’ office. When not in merce, as a poultry products broker, actual use, all such records shall be renderer, or animal food manufacturer, kept in a safe place at the prescribed or engages in business in commerce as location in accordance with good com- a wholesaler of any carcasses, or parts mercial practices. or products of the carcasses, of any poultry, whether intended for human § 381.177 Record retention period. food or other purposes, or engages in (a) Every record required to be main- the business as a public warehouseman tained under this subpart shall be re- storing any such articles in or for com- tained for a period not to exceed 2 merce, or engages in the business of years after December 31 of the year in buying, selling, or transporting in com- which the transaction to which the merce, or importing, any dead, dying, record relates has occurred, and for disabled, or diseased poultry, or parts such further period as the Adminis- of the carcasses of any poultry that trator may require for purposes of any died otherwise than by slaughter, shall investigation or litigation under the register with the Administrator, giving Act, by written notice to the person re- such information as is required, includ- quired to keep such record under this ing his name, and the address of each subpart. place of business at which, and all (b) Records of canning as required by trade names under which he conducts subpart X of this part 381, subchapter such business. Such persons shall reg- C, 9 CFR chapter III, shall be retained ister under this section by filing with

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the Administrator, Food Safety and In- § 381.181 Reports by consignees of al- spection Service, U.S. Department of legedly adulterated or misbranded Agriculture, Washington, DC 20250, a products; sale or transportation as form containing such information, violations. within 90 days after the effective date Whenever the consignee of any poul- hereof or after such later date as he be- try product which bears an official in- gins to engage in such business if not spection legend refuses to accept deliv- engaged therein upon said effective ery of such product on the grounds that date. All information submitted shall it is adulterated or misbranded, the be current and correct. The registra- consignee shall notify the appropriate tion form shall be obtained from the program supervisor, Meat and Poultry Compliance Program, Regulatory Pro- Inspection Program, Food Safety and grams, Food Safety and Inspection Inspection Service, U.S. Department of Service, U.S. Department of Agri- Agriculture, of the kind, quantity, culture, Washington, DC 20250. source and present location of the (b) Whenever any change is made in product and the respects in which it is the name of, or address of any place of alleged to be adulterated or mis- business at which, or any trade name branded, and it will be a violation of under which a registrant conducts his the Act for any person to sell or trans- business, he shall report such change in port, or offer for sale or transportation writing to the Administrator within 15 or receive for transportation, in com- days after making the change. merce, any such product which is capa- (c) The registration requirements ble of use as human food and is in fact prescribed in this section shall not adulterated or misbranded at the time apply to persons conducting any of the of such sale, transportation, offer, or businesses specified in this section only receipt: Provided, That any such alleg- at an official establishment. edly adulterated or misbranded product may be transported to any official es- [37 FR 9706, May 16, 1972, as amended at 39 tablishment for reinspection. FR 4569, Feb. 5, 1974; 57 FR 53982, Nov. 16, 1992] § 381.182 Reports of inspection work. § 381.180 Information and reports re- Reports of the inspection work car- quired from official establishment ried on within official establishments operators. shall be forwarded to the Adminis- (a) The operator of each official es- trator by the inspector in charge in tablishment shall furnish to Program such a manner as may be specified by employees accurate information as to the Administrator. all matters needed by them for making their daily reports of the amount of Subpart R—Cooperation With products prepared or handled in the de- States and Territories; Certifi- partments of the establishment to cation of State and Territorial which they are assigned and such re- Programs as at Least Equal to ports concerning sanitation, manda- Federal Program tory microbiological testing, and other aspects of the operations of the estab- § 381.185 Assistance to State and Terri- lishment and the conduct of inspection torial programs. thereat, as may be required by the Ad- (a) The Administrator is authorized, ministrator in special cases. under paragraph (a) of section 5 of the (b) The operator of each official es- Act, when he determines it would effec- tablishment shall also make such other tuate the purposes of the Act, to co- reports as the Administrator may from operate with any State (including time to time require under the Act. Puerto Rico) or any organized territory [37 FR 9706, May 16, 1972, as amended at 61 in developing and administering the FR 38868, July 25, 1996] poultry product inspection program of

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such jurisdiction, with a view to assur- ative program for this purpose is called ing that it imposes and enforces re- a Federal-State program. Under para- quirements at least equal to those graph (a) of section 5 of the Poultry under sections 2 through 4, 6 through Products Inspection Act, the Adminis- 10, and 12 through 22 of the Act, with trator is also authorized to conduct ex- respect to establishments at which aminations, investigations, and inspec- poultry are slaughtered or poultry tions under the Act through any officer products are processed for use as or employee of any State or territory human food, solely for distribution or the District of Columbia commis- within such jurisdiction, and with re- sioned by him for such purpose. spect to the poultry products of such establishments. Such cooperation is Subpart S—Transportation; Expor- authorized if the jurisdiction has entation; or Sale of Poultry or acted a mandatory law imposing ante Poultry Products mortem and post mortem inspection, reinspection, and sanitation require- § 381.189 Provisions inapplicable to ments (at least equal to those under specimens for laboratory examina- the Federal Act), with respect to all or tion, etc., or to naturally inedible certain classes of persons engaged in articles. slaughtering poultry or otherwise proc- The provisions of this Subpart do not essing poultry products for use as apply: human food solely for distribution (a) To dead, dying, disabled or dis- within such jurisdiction. eased poultry and specimens of (b) The Administrator is also author- undenatured, uninspected or adulter- ized under paragraph (a) of section 5 of ated carcasses, parts, or products of the Act, to cooperate with any State poultry sent to or by the Department (including Puerto Rico) or any orga- of Agriculture or divisions thereof in nized territory in developing and ad- Washington, DC, or elsewhere, for lab- ministering programs under the laws of oratory examination, exhibition pur- such jurisdiction containing authori- poses, or other official use; ties at least equal to those provided in (b) To dead, dying, disabled or dis- section 11 of the Act (relating to eased poultry and specimens of records; registration of specified class- undenatured, uninspected or adulter- es of operators; dead, dying, disabled, ated carcasses, parts, or products of or diseased poultry; and products not poultry thereof for educational, re- intended for human food) when he de- search, or other nonfood purposes termines that such cooperation would shipped under permit issued by the in- effectuate the purposes of the Act. spector in charge upon his determina- (c) Such cooperation may include ad- tion that collection and movement visory assistance, technical and labora- thereof will not interfere with inspec- tory assistance and training, and finan- tion or sanitary conditions at the es- cial aid. The Federal contribution to tablishment, and the specimens are for any State (or territory) for any year nonfood purposes. The person desiring shall not exceed 50 percent of the esti- such specimens shall make a written mated total cost of the cooperative application to the inspector in charge State (or territorial) program. A coop- for such permit on Form MP–112 and erative program under this section is shall obtain permission from the opera- called a State-Federal program. tor of the official establishment to obtain the specimens. Permits shall be is- § 381.186 Cooperation of States and sued for a period not longer than one other jurisdictions in Federal pro- year. The permit may be revoked by grams. the inspector in charge if he deter- Under the ‘‘Talmadge-Aiken Act’’ of mines after notice and opportunity to September 28, 1962 (7 U.S.C. 450), the present views is afforded to the permit- Administrator is authorized under tee that any such specimens were not stated conditions to utilize employees used as stated in the application, or if and facilities of any State in carrying the collection or handling of the speci- out Federal functions under the Poul- mens interferes with inspection or the try Products Inspection Act. A cooper- maintenance of sanitary conditions in

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the establishment. The specimens re- (3)(i) Poultry heads and feet that are ferred to in this paragraph shall be col- collected and handled at an official es- lected and handled only at such time tablishment in an acceptable manner and place and in such manner as not to may be shipped from the official estab- interfere with the inspection or to lishment and in commerce directly to cause any objectionable condition and another official establishment for proc- shall be identified as inedible when essing before export, provided the re- they leave the establishment. ceiving establishment maintains (c) To parts of poultry carcasses that records that: are naturally inedible by humans, such (A) Identify the source of the incom- as entrails and feathers in their natu- ing undenatured poultry product; ral state. (B) Identify the location of the product at all times during processing and [40 FR 55310, Nov. 28, 1975] preparation for export; and (C) Contain a written certification § 381.190 Transactions in slaughtered from an official of the receiving estab- poultry and other poultry products restricted; vehicle sanitation re- lishment that the undenatured poultry quirements. product intended for export has not been, and will not be, commingled with (a) No person shall sell, transport, any product intended for consumption offer for sale or transportation, or rein the United States. ceive for transportation, in commerce (ii) The receiving establishment may or from any official establishment, any only ship the undenatured poultry slaughtered poultry from which the product intended for export in accord- blood, feathers, feet, head, or viscera ance with the inspection and labeling have not been removed in accordance requirements of paragraph (b)(2) of this with the regulations. section. (b)(1) No person shall sell, transport, (c) No person, engaged in the busi- offer for sale or transportation, or re- ness of buying, selling, freezing, stor- ceive for transportation, in commerce, ing, or transporting, in or for com- any slaughtered poultry or other poul- merce, poultry products capable of use try product which is capable of use as as human food, or importing such arti- human food and is adulterated or fails cles, shall transport, offer for transpor- to bear an official inspection legend or tation, or receive for transportation, in is otherwise misbranded at the time of commerce or in any State designated such sale, transportation, offer or re- under § 381.221, any poultry product ceipt, except as otherwise provided in which is capable of use as human food this paragraph (b) and subpart C or T. and is not wrapped, packaged, or other- (2)(i) Poultry heads and feet that are wise enclosed to prevent adulteration collected and handled at an official es- by airborne contaminants, unless the tablishment in an acceptable manner railroad car, truck, or other means of may be shipped from the official estab- conveyance in which the product is lishment directly for export as human contained or transported is completely food, if they have been examined and enclosed with tight fitting doors or found to be suitable for such purpose, other covers for all openings. In all by an inspector and are labeled as pre- cases, the means of conveyance shall be scribed in this paragraph. reasonably free of foreign matter (such (ii) The containers of all such prod- as dust, dirt, rust, or other articles or ucts shall bear a label showing: (A) The residues), and free of chemical resi- name of the products; (B) the name and dues, so that product placed therein address of the packer or distributor, will not become adulterated. Any and, when the name of the distributor cleaning compound, lye, soda solution, is shown, it shall be qualified by such or other chemical used in cleaning the terms as ‘‘packed for,’’ ‘‘distributed means of conveyance must be thor- by,’’ or ‘‘distributors’’; and (C) the offi- oughly removed from the means of con- cial establishment number of the es- veyance prior to its use. Such means of tablishment where packed. conveyance onto which product is load- (iii) Such products shall not bear the ed, being loaded, or intended to be official inspection legend. loaded, shall be subject to inspection

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by an inspector at any official estab- ment ‘‘The poultry product contained lishment. The decision whether or not herein was inspected by the U.S.D.A.’’ to inspect a means of conveyance in a in the case of poultry products proc- specific case, and the type and extent essed in the United States, or the of such inspection shall be at the In- statement ‘‘The poultry products con- spection Service’s discretion and shall tained herein have been approved for be adequate to determine if poultry importation under P.P.I.A.’’ in the case product in such conveyance is, or when of imported poultry products. moved could become, adulterated. § 381.192 Penalties inapplicable to car- Circumstances of transport that can be riers. reasonably anticipated shall be considered in making said determination. No carrier shall be subject to the These include, but are not limited to, penalties of the Act, other than the weather conditions, duration and dis- penalties for violation of section 11, by tance of trip, nature of product cover- reason of his receipt, carriage, holding, ing, and effect of restowage at stops en or delivery, in the usual course of busi- route. Any means of conveyance found ness, as a carrier, of poultry or poultry upon such inspection to be in such con- products, owned by another person, un- dition that poultry product placed less the carrier has knowledge, or is in therein could become adulterated shall possession of facts which would cause a not be used until such condition which reasonable person to believe that such could cause adulteration is corrected. poultry or poultry products were not Poultry product placed in any means of inspected or marked in accordance conveyance that is found by the inspec- with the provisions of the Act or where tor to be in such condition that the otherwise not eligible for transpor- poultry product may have become tation under the Act, or unless the car- adulterated shall be removed from the rier refuses to furnish on request of a means of conveyance and handled in representative of the Secretary, the accordance with § 381.145(b). name and address of the person from whom he received such poultry or poul- [37 FR 9706, May 16, 1972, as amended at 39 FR 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, try products, and copies of all docu- 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, ments, if any there be, pertaining to Aug. 21, 1995] the delivery of the poultry or poultry products to such carrier. § 381.191 Distribution of inspected products to small lot buyers. § 381.193 Poultry carcasses, etc., not For the purpose of facilitating the intended for human food. distribution in commerce of inspected (a) Except as provided in paragraph poultry products to small lot buyers (b) of this section, poultry carcasses, (such as small restaurants), distribu- and parts and products thereof, that tors or jobbers may remove inspected are not intended for use as human food and passed non-consumer-packaged may, after they have been denatured as poultry carcasses or consumer- prescribed in § 381.95, be bought, sold, packaged poultry products from ship- transported, offered for sale or trans- ping containers or immediate contain- portation, or received for transpor- ers, other than consumer packages, and tation, in commerce, or imported, even place them into other containers which though they do not comply with all the do not bear an official inspection mark: provisions of the regulations, provided Provided, That the individual non- they are marked ‘‘Not fit for human consumer-packaged carcasses bear the food.’’ These requirements do not apply official inspection legend and the offi- to parts of poultry carcasses that are cial establishment number of the es- naturally inedible by humans, such as tablishment that processed the arti- entrails. cles; and the consumer-packaged arti- (b)(1) Except as provided in para- cles are fully labeled in accordance graphs (b) (2), (3), and (4) of this sec- with Subpart N: And provided further, tion, no animal food processed, in That the other container is marked whole or in part, from materials de- with the name and address of the dis- rived from the carcasses of poultry in tributor or jobber and bears the state- an official establishment or elsewhere,

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shall be bought, sold, transported, of- article’s intended use for animal food fered for sale or transportation, or re- are at least as high, wide, and thick as ceived for transportation in commerce, the letters indicating the presence of or imported, unless: material derived from any poultry car- (i) It is properly identified as animal cass. However, when the label bears on food; its principal display panel a vignette (ii) It is not represented as being a which pictures, in clearly recognizable human food; and form and size, one or more animals of (iii) It has been denatured as pre- the species for which the article’s name scribed in § 381.95 so as to be readily indicates the article is intended, the distinguishable from an article of letters used to state the article’s in- human food. tended use shall be at least one-half as (2) Notwithstanding the provisions of high, wide, and thick as the letters paragraph (b)(1) of this section, an ani- used in the article’s name or other let- mal food that consists of less than 5 ters indicating the presence of mate- percent of parts or products of the car- rial derived from any poultry carcass, casses of poultry and that is not rep- but shall not be less than 1⁄8 inch high. resented by labeling or appearance or The letters used to state the article’s otherwise as being a human food or as intended use may be separated from a product of the poultry industry need the article’s name by the vignette. not be denatured in accordance with (iii) Letters used to denote the in- § 381.95. tended use of the article must contrast (3) Notwithstanding the provisions of as markedly with their background as paragraph (b)(1) of this section, animal the letters indicating the presence in food packed in hermetically sealed, re- the article of poultry carcass-source tort processed, conventional retail-size material contrast with their back- containers, and retail-size packages of ground. semi-moist animal food need not be de- (4) The requirements of this part do natured in accordance with § 381.95 if not apply to livestock or poultry feed the name of the article clearly conveys manufactured from processed poultry the article’s intended use for animal byproducts (such as poultry byproduct food and appears on the label in a con- meal, hydrolyzed poultry feathers, and spicuous manner. hydrolyzed poultry byproducts aggre- (i) Except as provided in paragraph gate), or to processed dry animal food. (ii) of paragraph (b)(3) of this section, [49 FR 47479, Dec. 5, 1984] the name of the article must be stated on the label as ‘‘Animal Food,’’ ‘‘Pet § 381.194 Transportation and other Food,’’ or ‘‘(name of species) Food’’ transactions concerning dead, (e.g., ‘‘Dog Food’’ or ‘‘Cat Food’’). To dying, disabled, or diseased poultry, be considered conspicuous, the name of and parts of carcasses of poultry the article, wherever it appears on the that died otherwise than by slaugh- label, must be stated in letters at least ter. twice as high, wide, and thick as the No person engaged in the business of letters indicating the presence in the buying, selling, or transporting in com- article of any ingredients derived from merce, or importing any dead, dying, carcasses of poultry. disabled, or diseased poultry or parts of (ii) Notwithstanding the provisions of the carcasses of any poultry that died paragraph (i) of paragraph (b)(3) of this otherwise than by slaughter shall: section, the article’s name may be (a) Sell, transport, offer for sale or stated on the label to show that it is or transportation or receive for transpor- contains poultry carcass-source mate- tation, in commerce, any dead, dying, rial and that the article is for animals; disabled, or diseased poultry, or parts e.g., ‘‘Chicken for Pets’’ or ‘‘Turkey of the carcasses of any poultry that Dinner for Cats’’: Provided, That the died otherwise than by slaughter, un- entire name of the article is stated, less such poultry and parts are con- wherever it appears on the label, as an signed and delivered, without avoidable individual, contiguous unit, whether delay, to establishments of animal food stated on a single line or more than manufacturers, renderers, or collection one line, and the letters denoting the stations that are registered as required

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by § 381.179, or to official establish- (2) For product from eligible coun- ments that operate under Federal in- tries other than Canada: spection, or to establishments that op- (i) Offer(ed) for entry. The point at erate under a State or Territorial in- which the importer presents the im- spection system approved by the Sec- ported product to the Program for rein- retary as one that imposes require- spection. ments at least equal to the Federal re- (ii) Entry (entered). The point at quirements for purposes of section 5(c) which imported product offered for of the Act. entry receives reinspection and is (b) Buy in commerce or import any marked with the official mark of in- dead, dying, disabled, or diseased poul- spection in accordance with § 327.26 of try or parts of the carcasses of any this part. poultry that died otherwise than by (3) For product from Canada: slaughter, unless he is an animal food (i) Offer(ed) for entry from establish- manufacturer or renderer and is reg- ments participating in the ‘‘stream- istered as required by § 381.179, or is the lined’’ inspection procedures. The point operator of an establishment inspected at which an official of the Canadian in- as required by paragraph (a) of this sec- spection system contacts the Import tion and such poultry or parts of car- Field Office for an inspection assign- casses are to be delivered to establishment. ments eligible to receive them under (ii) Offer(ed) for entry from non- paragraph (a) of this section. participating establishments. The (c) Unload en route to any establish- point at which the importer presents ment eligible to receive them under the imported product to the Program paragraph (a) of this section, any dead, for reinspection. dying, disabled, or diseased poultry or (iii) Entry (entered) for product not parts of the carcasses of any poultry subject to reinspection. When the con- that died otherwise than by slaughter, tainers or the products themselves if which are transported in commerce or not in containers are marked with the imported by any such person: Provided, Canadian export stamp and upon the That any such dead, dying, disabled, or filing of Customs Form 7533 at the port diseased poultry, or parts of carcasses of entry or at the nearest customs- may be unloaded from a means of con- house in accordance with 19 CFR part veyance en route where necessary in 123. case of a wreck or otherwise extraor- (iv) Entry (entered) for product sub- dinary emergency, and may be reloaded ject to reinspection. When the contain- into another means of conveyance; but ers or the products themselves if not in in all such cases, the carrier shall im- containers are marked with the Cana- mediately report the facts by telegraph dian export stamp and the foreign in- or telephone to the Director, Compli- spection certificate accompanying the ance Staff, Meat and Poultry Inspec- product is stamped as ‘‘Inspected and tion Program, Food Safety and Inspec- Passed’’ by the import inspector. tion Service, U.S. Department of Agri- (b) No slaughtered poultry, or parts culture, Washington, DC 20250. or products thereof, shall be imported into the United States unless they are [40 FR 55310, Nov. 28, 1975] healthful, wholesome, fit for human food, not adulterated, and contain no Subpart T—Imported Poultry dye, chemical, preservative, or ingredi- Products ent which renders them unhealthful, unwholesome, adulterated, or unfit for § 381.195 Definitions; requirements for human food and they also comply with importation into the United States. the regulations prescribed in this sub- (a) When used in this part, the fol- part to assure that they comply with lowing terms shall be construed to the standards provided for in the Act: mean: Provided, That the provisions of this (1) Import (Imported). To bring within subpart apply to such articles only if the territorial limits of the United they are capable of use as human food. States whether that arrival is accom- (c) Except as provided in § 381.207, plished by land, air, or water. slaughtered poultry and other poultry

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products may be imported only if they throughout the system at which poul- were processed solely in countries list- try products are processed for export to ed in § 381.196(b). Slaughtered poultry the United States; may be imported only if it qualifies as (B) Ultimate control and supervision ready-to-cook poultry. by the national government over the official activities of all employees or [37 FR 9706, May 16, 1972, as amended at 40 FR 42338, Sept. 12, 1975; 54 FR 41049, Oct. 5, licensees of the system; 1989] (C) The assignment of competent, qualified inspectors; § 381.196 Eligibility of foreign coun- (D) Authority and responsibility of tries for importation of poultry national inspection officials to enforce products into the United States. the requisite laws and regulations gov- (a)(1) Whenever it shall be deter- erning poultry inspection and to cer- mined by the Administrator that the tify or refuse to certify poultry prod- system of poultry inspection main- ucts intended for export; tained by any foreign country, with re- (E) Adequate administrative and spect to establishments preparing prod- technical support; ucts in such country for export to the (F) The inspection, sanitation, qual- United States, insures compliance of ity, species verification, and residue such establishments and their poultry standards applied to products produced products, with requirements equivalent in the United States. to all the provisions of the Act and the (G) Other requirements of adequate regulations in this part which are ap- inspection service as required by the plied to official establishments in the regulations. United States, and their poultry prod- (ii) The legal authority for the sys- ucts, and that reliance can be placed tem and the regulations thereunder upon certificates required under this shall impose requirements equivalent subpart from authorities of such for- to those governing the system of poul- eign country, notice of that fact will be try inspection organized and main- given by including the name of such tained in the United States with re- foreign country in paragraph (b) of this spect to: section. Thereafter, poultry products (A) Ante mortem inspection of poul- processed in such establishments which try for slaughter, which shall be per- are certified and approved in accord- formed by veterinarians or by other ance with paragraph (a)(3) of this sec- employees or licensees of the system tion shall be eligible, so far as the reg- under the direct supervision of veteri- ulations in this part are concerned, for narians; importation into the United States (B) Post mortem inspection of car- from such foreign country after appli- casses and parts thereof at time of cable requirements of this part have slaughter, performed by veterinarians been met. or other employees or licensees of the (2) The determination of accept- system under the direct supervision of ability of a foreign poultry inspection veterinarians; system for purposes of this section (C) Official controls by the national shall be based on an evaluation of the government over establishment con- foreign program in accordance with the struction, facilities, and equipment; following requirements and procedures: (D) Direct and continuous official su- (i) The system shall have a program pervision of slaughtering of poultry organized and administered by the na- and processing of poultry products, by tional government of the foreign coun- the assignment of inspectors to estab- try. The system as implemented must lishments certified under paragraph provide standards equivalent to those (a)(3) of this section to assure that of the Federal system of poultry in- adulterated or misbranded poultry spection in the United States with re- products are not processed for export spect to: to the United States; (A) Organizational structure and (E) Complete separation of establish- staffing, so as to insure uniform en- ments certified under subparagraph (3) forcement of the requisite laws and of this paragraph from establishments regulations in all establishments not certified, and the maintenance of a

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single standard of inspection and sani- graph (a)(3) of this section to assure tation throughout all certified estab- that requirements referred to in para- lishments; graphs (a)(2)(ii)(A) through (a)(2)(ii)(H) (F) Requirements for sanitation at of this section are being met: Provided, certified establishments and for sani- that such visits are not required with tary handling of poultry products; respect to any establishment during a (G) Official controls over condemned period when the establishment is not material until destroyed or removed operating or is not engaged in produc- and thereafter excluded from the estab- ing products for exportation to the lishment; United States; (H) A Hazard Analysis and Critical (B) Written reports prepared by the Control Point (HACCP) system, as set representative of the foreign inspection forth in part 417 of this chapter. system who has conducted a super- (I) Other matters for which require- visory visit, documenting his or her ments are contained in the Act or the findings with respect to the require- regulations in this part. ments referred to in paragraphs (iii) Countries desiring to establish (a)(2)(ii)(A) through (a)(2)(ii)(H) of this eligibility for importation of poultry section, copies of which shall be made products into the United States may available to the representative of the request a determination of eligibility Department at the time of the rep- by presenting copies of the laws and resentative’s review upon request by regulations on which the foreign poul- that representative to a responsible try inspection system is based and such foreign inspection official: Provided, other information as the Adminis- that such reports are not required dur- trator may require with respect to ing a period when the establishment is matters enumerated in paragraphs not operating or not engaged in pro- (a)(2) (i) and (ii). Determination of eli- ducing products for exportation to the gibility is based on a study of the docu- United States. ments and other information presented (C) Random sampling and testing at and an initial review of the system in the point of slaughter of carcasses, in- operation by a representative of the cluding internal organs and fat, for res- Department using the criteria listed in idues identified by the exporting coun- paragraphs (a)(2) (i) and (ii) of this sec- try’s inspection authorities or by this tion. Maintenance of eligibility of a Agency as potential contaminants, in country for importation of poultry accordance with sampling and analyt- products into the United States de- ical techniques approved by the Admin- pends on the results of periodic reviews istrator: Provided, that such testing is of the foreign poultry inspection sys- required only on samples taken of car- tem in operation by a representative of casses from which poultry or poultry the Department, and the timely sub- products intended for importation into mission of such documents and other the United States are produced. information related to the conduct of (3) Only those establishments that the foreign inspection system as the are determined and certified to the De- Administrator may find pertinent to partment by a responsible official of and necessary for the determinations the foreign poultry inspection system required by this section. as fully meeting the requirements of (iv) The foreign inspection system paragraphs (a)(2) (i) and (ii) of this sec- must maintain a program to assure tion are eligible to have their products that the requirements referred to in imported into the United States. Eligi- this section, equivalent to those appli- bility of certified establishments is cable to the Federal system in the subject to review by the Department United States, are being met. The pro- (including observations of the estab- gram as implemented must provide for lishments by Program representatives the following: at times prearranged with the officials (A) Periodic supervisory visits by a of the foreign inspection system). Cer- representative of the foreign inspection tifications of establishments must be system not less frequently than one renewed annually. Notwithstanding such visit per month to each establish- certification by a foreign official, the ment certified in accordance with para- Administrator may, at his discretion,

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terminate the eligibility of any foreign ments in the United States; or that re- establishment for importation of its liance cannot be placed upon certifi- poultry products into the United cates required under this subpart from States if he has information that such authorities of such foreign country; or establishment does not comply with that, for lack of current information the requirements listed in paragraphs concerning the system of poultry in- (a)(2) (i) and (ii) of this section or if he spection being maintained by such for- cannot obtain current information con- eign country, such foreign country cerning such establishment. The Ad- should be required to reestablish its ministrator will provide reasonable no- eligibility for listing. tice to the foreign government of the (b) It has been determined that poul- proposed termination of eligibility of try products from the following coun- any foreign establishment for importa- tries, covered by foreign poultry in- tion of its poultry products into the spection certificates of the country of United States unless, in his judgment, origin as required by § 381.197, are eligi- delay in terminating its eligibility ble under the regulations in this sub- could result in the importation of any part for entry into the United States, adulterated or misbranded poultry after inspection and marking as re- products. Certifications of official es- quired by the applicable provisions of tablishments by the responsible official this subpart: 1 of the foreign poultry inspection system shall be in the following form: Canada. France. FOREIGN OFFICIAL POULTRY ESTABLISHMENT Great Britain. CERTIFICATE Hong Kong. Israel. I hereby certify that the establishment(s) listed below fully complies (comply) with re- [37 FR 9706, May 16, 1972, as amended at 43 quirements of (specify foreign country) FR 8117, Feb. 28, 1978; 52 FR 23021, June 17, equivalent to all the provisions of the Poul- 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, try Products Inspection Act and regulations Oct. 30, 1989; 60 FR 38668, July 28, 1995; 61 FR issued thereunder, which apply to official es- 38868, July 25, 1996] tablishments in the United States, and their poultry products, as provided in § 381.197 Imported products; foreign § 381.196(a)(2)(i) and (ii) of the poultry prod- inspection certificates required. ucts inspection regulations of the United (a) Except as provided in §§ 381.207 States. and 381.209, each consignment contain- Control numbers Name ing any slaughtered poultry or other Address poultry product consigned to the Unit- ed States from a foreign country shall ———————————————————————— ———————————————————————— be accompanied with a foreign inspec- ———————————————————————— tion certificate substantially in the form illustrated in paragraph (b) of Date——————. —————————————— this section. (Signature) (b) The form of foreign poultry prod- —————————————— uct inspection certificate shall be as (Official title) follows:

(4) Poultry products from foreign FOREIGN POULTRY PRODUCT INSPECTION countries not listed in paragraph (b) of CERTIFICATE this section are not eligible for impor- Place ———————————————————— tation into the United States, except (City) as provided by §§ 381.207 and 381.209. The —————————————— listing of any foreign country under (Country) this section may be withdrawn when- Date ————————————————————— ever it shall be determined by the Ad- I hereby certify that the poultry products ministrator that the system of poultry herein described were derived from poultry inspection maintained by such foreign country does not assure compliance 1Listing of any country in this section with requirements equivalent to all the does not relieve the poultry products of such requirements of the Act and the regu- country from applicable requirements under lations as applied to official establish- other Federal laws.

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which received ante mortem and post it, the name of the country where the mortem inspections at the time of slaughter; product was processed, the name of the and that such poultry products are sound, country from which the product was healthful, wholesome, clean and otherwise fit for human food, and are not adulterated shipped, the place of destination, the and have not been treated with and do not quantity and kind of product, whether contain any dye, chemical, preservative, or fresh, frozen, cured, or canned, and the ingredient not permitted by the regulations point of first arrival in the United governing the inspection of poultry and poul- States. try products of the U.S. Department of Agri- (b) For participating Canadian estab- culture, filed with me, and that said poultry lishments, an official of the Canadian products have been handled only in a sani- meat inspection system shall contact tary manner in this country; and are otherwise in compliance with requirements at the Import Field Office for an inspec- least equal to those in the Poultry Products tion assignment (see § 301.2(yyy)). Inspection Act and said regulations. (1) If the Automated Import Informa- tion System (AIIS) does not designate KIND OF PRODUCT the consignment for reinspection, the ———————————————————————— consignment may be transported to its ———————————————————————— consignee for further distribution. ———————————————————————— (2) If the AIIS designates the consign- Number of pieces or packages Weight ment for reinspection, the official shall: ———————————————————————— ———————————————————————— (i) Select samples in accordance with ———————————————————————— USDA sampling tables. Identification marks on containers ————— (ii) Identify and place samples in the Consignor —————————————————— vehicle for easy removal and reinspec- Address ——————————————————— tion by a Program import inspector. Consignee —————————————————— (3) In the event that any one of the Destination ————————————————— requirements provided in paragraph Shipping marks ——————————————— (Signature) —————————————— (d)(2) of this section is not met, inspec- (Name of official of national foreign govern- tion of the consignment shall be con- ment authorized to issue inspection certifi- duced by a Program import inspector cates for poultry products exported to the in accordance with established proce- United States) dures provided for in the regulations (Official title) ————————————— for other imported products. [37 FR 9706, May 16, 1972, as amended at 40 [37 FR 9706, May 16, 1972, as amended at 39 FR 42338, Sept. 12, 1975] FR 4569, Feb. 5, 1974; 51 FR 37710, Oct. 24, 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. 5, § 381.198 Importer to make application 1989] for inspection of poultry products offered for entry. § 381.199 Inspection of poultry prod- (a) Each person who wishes to offer ucts offered for entry. for entry any slaughtered poultry or (a)(1) Except as provided in other poultry product shall make ap- §§ 381.198(b)(1) and 381.209 of this part, plication for inspection to the import and paragraph (c) of this section, all supervisor of the import field office at slaughtered poultry and poultry prod- the port where the poultry product is ucts offered for entry from any foreign to be offered for entry, or to the Ad- country shall be reinspected by a Pro- ministrator, Food Safety and Inspec- gram import inspector before they tion Service, U.S. Department of Agri- shall be allowed entry into the United culture, Washington, DC 20250, as long States. as possible in advance of the antici- (2) Every lot of product shall rou- pated arrival of each consignment of tinely be given visual inspection for such product, except in the case of appearance and condition, and checked poultry product exempted from inspec- for certification and label compliance, tion by §§ 381.207 or 381.209. Each appli- except as provided in § 381.198(b)(1). cation shall state the approximate date (3) The computerized Automated Im- on which the consignment is due to ar- port Information System (AIIS) shall rive in the United States, the name of be consulted for reinspection instruc- the ship or other carrier transporting tions. The AIIS will assign inspection

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levels and procedures based on estab- (iii) If the defective containers in the lished sampling plans or established consignment have been sorted out and product and plant history and estab- exported or destroyed under the super- lished sampling plans. vision of an inspector. (b) Inspectors may take, without cost (2) Representative samples of canned to the United States, from each con- product designated by the Adminis- signment of poultry products offered trator in instructions to inspectors for entry, such samples of the products shall be incubated under the super- as are deemed necessary to determine vision of such inspectors in accordance the eligibility of the products for entry with § 381.309 (d)(1)(ii), (d)(1)(iii), into the commerce of the United (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and States. (d)(1)(viii) of this subchapter. The im- (c) Poultry products imported under porter or his/her agent shall provide § 381.207 shall not be sampled and in- the necessary incubation facilities in spected under this section unless there accordance with § 381.309(d)(1)(i) of this is reason for suspecting the presence subchapter. therein of a substance in violation of (3) Sampling plans and acceptance that section, and in such case they levels as prescribed in paragraphs (d)(1) shall be sampled and inspected in ac- and (d)(2) of this section may be ob- cordance with paragraph (a) of this sec- tained, upon request, from Inter- tion. national Programs, Food Safety and (d) In addition to the provisions spec- Inspection Service, U.S. Department of ified in paragraphs (a), (b), and (c) of Agriculture, Washington, DC 20250. this section, the following require- [37 FR 9706, May 16, 1972, as amended at 49 ments apply to imported canned prod- FR 36819, Sept. 20, 1984; 51 FR 45633, Dec. 19, uct. 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. (1) Imported canned products are re- 5, 1989] quired to be sound, healthful, properly § 381.200 Poultry products offered for labeled, wholesome, and otherwise not entry, retention in customs custody; adulterated at the time the products delivery under bond; movement are offered for importation into the prior to inspection; handling; facili- United States. Provided other require- ties and assistance. ments of this part are met, the deter- (a) No slaughtered poultry or other mination of the acceptability of the poultry product required by this sub- product and the condition of the con- part to be inspected shall be released tainers shall be based on the results of from customs custody prior to inspec- an examination of a statistical sample tion, but such product may be deliv- drawn from the consignment as pro- ered to the consignee, or his agent, vided in paragraph (a) of this section. If prior to inspection, if the consignee the inspector determines, on the basis shall furnish a bond, in form prescribed of the sample examination, that the by the Secretary of the Treasury, con- product does not meet the require- ditioned that the product shall be re- ments of the Act and regulations there- turned, if demanded, to the collector of under, the consignment shall be re- the port where the same is offered for fused entry. However, a consignment clearance through the customs. rejected for container defects but oth- (b) Except as provided in paragraph erwise acceptable may be reoffered for (a) of this section, no product required inspection under the following condi- by this subpart to be inspected shall be tions: moved, prior to inspection, from the (i) If the defective containers are not port of arrival where first unloaded, indicative of an unsafe or unstable and if arriving by water, from the product as determined by the Adminis- wharf where first unloaded at such trator; port, to any place other than the place (ii) If the number and kinds of con- designated in accordance with this sub- tainer defects found in the original part as the place where the same shall sample do not exceed the limits speci- be inspected; and no product shall be fied for this purpose in FSIS guide- conveyed in any manner other than in lines; and compliance with this subpart.

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(c) The consignee, or his agent, shall transferred, the subsequent purchaser furnish such facilities and shall provide will still be required to export the such assistance for handling and mark- product or have it destroyed as speci- ing poultry products offered for entry fied in the notice under paragraph as the inspector may require. (a)(4) of this section. [37 FR 9706, May 16, 1972, as amended at 51 (3) No lot of product which has been FR 37710, Oct. 24, 1986; 54 FR 41050, Oct. 5, refused entry may be subdivided during 1989; 56 FR 65180, Dec. 16, 1991] disposition pursuant to paragraph (a)(2) of this section, except that re- § 381.201 Means of conveyance and equipment used in handling poultry moval and destruction of any damaged products offered for entry to be or otherwise unsound product from a maintained in sanitary condition. lot destined for reexportation is per- Compartments of steamships, rail- mitted under supervision of USDA road cars, and other means of convey- prior to exportation. Additionally, ance transporting any poultry product such refused entry lot may not be to the United States, and all chutes, shipped for export from any port other platforms, racks, tables, tools, uten- than that through which the product sils, and all other devices used in mov- came into the United States without ing and handling any poultry product the expressed consent of the Adminis- offered for entry into the United trator, based on full information con- States, shall be maintained in a sani- cerning the product’s disposition, in- tary condition. cluding the name of the vessel and the date of export. For the purposes of this § 381.202 Poultry products offered for entry; reporting of findings to cus- paragraph, the term ‘‘lot’’ shall refer toms; handling of articles refused to that product identified on MP Form entry; appeals, how made; denatur- 410 in the original request for inspec- ing procedures. tion for importation pursuant to (a)(1) Program inspectors shall report § 381.198. their findings as to any product which (4) The owner or consignee shall have has been inspected in accordance with 45 days after notice is given by FSIS to this part, to the Director of Customs at the Director of Customs at the original the original port of entry. port of entry to take the action re- (2) When product has been identified quired in paragraph (a)(2) of this sec- as ‘‘U.S. refused entry,’’ the inspector tion for ‘‘refused entry’’ product. Ex- shall request the Director of Customs tension beyond the 45-day period may to refuse admission to such product be granted by the Administrator when and to direct that it be exported by the extreme circumstances warrant it; e.g., owner or consignee within the time specified in this section, unless the a dock workers’ strike or an unforesee- owner or consignee, within the speci- able vessel delay. fied time, causes it to be destroyed by (5) If the owner or consignee fails to disposing of it under the supervision of take the required action within the a Program employee so that the prod- time specified under paragraph (a)(4) of uct can no longer be used as human this section, the Department will take food, or by converting it to animal food such actions as may be necessary to ef- uses, if permitted by the Food and fectuate its order to have the product Drug Administration. The owner or destroyed for human food purposes. consignee of the refused entry product The Department shall seek court costs shall not transfer legal title to such and fees, storage, and proper expenses product, except to a foreign consignee in the appropriate forum. for direct and immediate exportation, (6) No product which has been refused or an end user, e.g., an animal food entry and exported to another country manufacturer or a renderer, for de- pursuant to paragraph (a)(2) of this sec- struction for human food purposes. tion may be returned to the United ‘‘Refused entry’’ product must be deliv- States under any circumstance. Any ered to and used by the manufacturer or renderer within the 45-day time such product so returned to the United limit. Even if such title is illegally

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States shall be subject to administra- dues, shall be disposed of by one of the tive detention in accordance with sec- following methods, under the super- tion 19 of the Act, and seizure and con- vision of an inspector of the Inspection demnation in accordance with section Service. (Facilities and materials for 20 of the Act. carrying out the requirements in this (b) Upon the request of the Director section shall be furnished by the offi- of Customs at the port where a product cial establishments.) is offered for clearance through the (1) Steam treatment (which shall be customs, the consignee of the product accomplished by processing the con- shall, at the consignee’s own expense, demned product in a pressure tank immediately return to the Director under at least 40 pounds of steam pres- any product which has been delivered sure) or thorough cooking in a kettle to consignee under this subpart and subsequently designated ‘‘U.S. Refused or vat, a sufficient time to effectively Entry’’ or found in any request not to destroy the product for human food comply with the requirements in this purposes and preclude dissemination of subpart. disease through consumption by ani- (c) Except as provided in § 381.200(a) mals. (Tanks and equipment used for or (b), no person shall remove or cause this purpose or for rendering or prepar- to be removed from any place des- ing inedible products shall be in rooms ignated as the place of inspection, any or compartments separate from those poultry product which the regulations used for the preparation of edible prod- in this subpart require to be marked in ucts. There shall be no direct connec- any way, unless the same has been tion by means of pipes, or otherwise, clearly and legibly marked in compli- between tanks containing inedible ance with this subpart. products and those containing edible (d) Any person receiving inspection products.) service may, if dissatisfied with any (2) Incineration or complete destruc- decision of an inspector relating to any tion by burning. inspection, file an appeal from such de- (3) Chemical denaturing, which shall cision: Provided, That such appeal is be accomplished by the liberal applica- filed within 48 hours from the time the tion to all carcasses and parts thereof, decision was made. Any such appeal of: from a decision of an inspector shall be made to his/her immediate supervisor (i) Crude carbolic acid, having jurisdiction over the subject (ii) Kerosene, fuel oil, or used crank- matter of the appeal, and such super- case oil, or visor shall determine whether the in- (iii) Any phenolic disinfectant con- spector’s decision was correct. Review forming to commercial standards CS of such appeal determination, when re- 70–41 or CS 71–41 which shall be used in quested, shall be made by the imme- at least 2 percent emulsion or solution. diate supervisor of the employee of the (4) Any other substances or method Department making the appeal deter- that the Administrator approves in mination. The cost of any such appeal specific cases, which will denature the shall be borne by the appellant if the poultry product to the extent nec- Administrator determines that the ap- essary to accomplish the purposes of peal is frivolous. The charges for such this section. frivolous appeal shall be at the rate of (5) Carcasses and parts of carcasses $9.28 per hour for the time required to condemned for biological residue shall make the appeal inspection. The poul- be disposed of in accordance with para- try or poultry products involved in any graph (e)(2) of this section or by bury- appeal shall be identified by U.S. re- ing under the supervision of an inspec- tained tags and segregated in a manner approved by the inspector pending tor. completion of an appeal inspection. [37 FR 9706, May 16, 1972, as amended at 48 (e) All condemned carcasses, or con- FR 15890, Apr. 13, 1983; 50 FR 19908, May 13, demned parts of carcasses, or other 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, condemned poultry products, except May 13, 1988; 54 FR 50735, Dec. 11, 1989; 60 FR those condemned for biological resi- 67458, Dec. 29, 1995]

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§ 381.203 Products offered for entry; charges for storage, cartage, and labor with respect to products which are refused entry. All charges for storage, cartage, and labor with respect to any product offered for entry which is refused entry pursuant to the regulations shall be paid by the owner or consignee and, in default of such payment, shall constitute a lien against any other products offered for entry thereafter by or for such owner or consignee. [54 FR 41050, Oct. 5, 1989]

§ 381.204 Marking of poultry products offered for entry; official import inspection marks and devices. (a) Except for products offered for entry from Canada, poultry products FIGURE 1 which upon reinspection are found to (c) When products are refused entry be acceptable for entry into the United into the United States, the official States shall be marked with the offi- mark to be applied to the products re- cial inspection legend shown in para- fused entry shall be in the following graph (b) of this section. Such inspec- form: tion legend shall be placed upon such products only after completion of official import inspection and product acceptance. (b) The official mark for marking poultry products offered for entry as ‘‘U.S. inspected and passed’’ shall be in the following form, and any device approved by the Administrator for applying such mark shall be an official de- FIGURE 2 vice.2 (d) The import warning notice prescribed in § 381.200(c) is an official mark. (e) The ordering and manufacture of brands shall be in accordance with the provisions contained in § 317.3(c) of the Federal meat inspection regulations. (f) The inspection legend may be placed on containers of product before completion of official import inspection if the containers are being inspected by an import inspector who reports to an Import Field Office Super- visor, the product is not required to be held at the establishment pending the receipt of laboratory test results; and a 2 The number ‘‘I–42’’ is given as an example only. The establishment number of the official establishment or official import inspection establishment where the product was inspected shall be shown on each stamp impression.

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written procedure for controlled istrator shall grant or deny the appeal, stamping, submitted by the import es- in writing, stating the reasons for such tablishment and approved by the Direc- decision, as promptly as circumstances tor, Import Inspection Division, is on allow. If there is a conflict as to any file at the import inspection facility material fact, a hearing shall be held where the inspection is to be per- to resolve such conflict. Rules of prac- formed. tice concerning such a hearing will be (1) The written procedure for con- adopted by the Administrator. The trolled pre-stamping should be in the cancellation of the controlled pre- form of a letter and shall include the stamping privilege will be in effect following: until there is a final determination in (i) That stamping under this subpart the proceeding. will be limited to those lots of product (Approved by the Office of Management and which can be inspected on the day that Budget under control number 0583–0015) certificates for the product are exam- [51 FR 37710, Oct. 24, 1986, as amended at 53 ined; FR 17015, May 13, 1988; 54 FR 41050, Oct. 5, (ii) That all products which have 1989] been pre-stamped will be stored in the facility where the import inspection § 381.205 Labeling of immediate con- will occur; tainers of poultry products offered (iii) That inspection marks applied for entry. under this part will be removed from (a) Immediate containers of poultry any lot of product subsequently refused products imported into the United entry on the day the product is re- States shall bear a label printed in jected; and English showing in accordance with (iv) That the establishment will subpart N of this part all information maintain a daily stamping log contain- required by that section (except that ing the following information for each the inspection mark and establishment lot of product: the date of inspection, number assigned by the foreign poultry the country of origin, the foreign es- inspection system and certified to the tablishment number, the product Inspection Service shall be shown in- name, the number of units, the ship- stead of the official dressed poultry ping container marks, and the MP–410 identification mark or other official in- number covering the product to be inspection legend, and official establish- spected. The daily stamping log must ment number); and in addition the be retained by the establishment in ac- label shall show the name of the coun- cordance with the requirements of try of origin preceded by the words § 381.177. ‘‘Product of,’’ which statement shall (2) An establishment’s controlled pre- appear immediately under the name of stamping privilege may be cancelled the product. orally or in writing by the inspector (b) The labels shall not be false or who is supervising its enforcement misleading in any respect. whenever the inspector finds that the (c) All marks and other labeling for establishment has failed to comply use on or with immediate containers with the provisions of this subpart or shall be approved for use by the Food any conditions imposed pursuant Safety and Inspection Service in ac- thereto. If the cancellation is oral, the cordance with §§ 381.132 and 381.133 be- decision and the reasons therefor shall fore products bearing such marks and be confirmed in writing, as promptly as other labeling will be permitted for circumstances allow. Any person whose entry into the United States. controlled pre-stamping privilege has [37 FR 9706, May 16, 1972, as amended at 39 been cancelled may appeal the decision FR 4569, Feb. 5, 1974; 54 FR 41050, Oct. 5, 1989; to the Administrator, in writing, with- 60 FR 67458, Dec. 29, 1995] in ten (10) days after receiving written notification of the cancellation. The § 381.206 Labeling of shipping contain- appeal shall state all of the facts and ers of poultry products offered for reasons upon which the person relies to entry. show that the controlled pre-stamping Shipping containers of imported was wrongfully cancelled. The Admin- poultry products are required to bear

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in a prominent and legible manner the with this subpart, shall be deemed and name of the product, the name of the treated and, except as provided in country of origin, the foreign inspec- § 381.207, shall be handled and trans- tion system establishment number of ported as domestic products, and shall the establishment in which the product be subject to the applicable provisions was processed, and the inspection mark of this part and to the provisions of the of the country of origin. Labeling on Poultry Products Inspection Act and shipping containers shall be examined the Federal Food, Drug, and Cosmetic at the time of inspection in the United Act. States and if found to be false or mis- (b) Poultry products entered in ac- leading, the product shall be refused cordance with this subpart may, sub- entry. All labeling used with a shipping ject to the provisions of the regula- container of imported poultry products tions, be taken into official establish- must be approved in accordance with ments and be mixed with or added to subpart N of this part. poultry products that are inspected and passed or exempted from inspec- [37 FR 9706, May 16, 1972, as amended at 54 tion in such establishments. FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, (c) Imported poultry products which 1995] have been inspected, passed, and § 381.207 Small importations for con- marked under this subpart may be signee’s personal use, display, or transported in commerce, only upon laboratory analysis. compliance with the applicable regula- Any poultry product (other than one tions. which is forbidden entry by other Fed- [37 FR 9706, May 16, 1972, as amended at 54 eral law or regulation) from any coun- FR 41050, Oct. 5, 1989] try in quantities of less than 50 pounds net weight, exclusively for the personal § 381.209 Returned United States in- use of the consignee, or for display or spected and marked poultry products; exemption. laboratory analysis by the consignee, and not for sale or distribution; which Poultry products which have been in- is sound, healthful, wholesome, and fit spected and passed by the U.S. Depart- for human food, and which is not adul- ment of Agriculture and are so marked, terated and contains no substance not and are returned from foreign coun- permitted by the Act or regulations, tries, may be imported if they are not may be imported into the United adulterated or misbranded at the time States without a foreign inspection of such return. Such products are ex- certificate, and such product is not re- empted from further requirements quired to be inspected upon arrival in under this part. Such returned ship- the United States and may be shipped ments shall be reported to the Admin- to the consignee without further re- istrator by letter prior to arrival at the striction under this part, except as pro- United States port of entry. vided in § 381.199(c): And provided, That the Department may with respect to Subpart U—Detention; Seizure and any specific importation, require that Condemnation; Criminal Offenses the consignee certify that such product is exclusively for the personal use of § 381.210 Poultry and other articles said consignee, or for display or labora- subject to administrative detention. tory analysis by said consignee, and Any poultry carcass, or part thereof; not for sale or distribution. or any product made wholly or in part from any poultry carcass or part there- [37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989] of; or any dead, dying, disabled, or diseased poultry is subject to detention § 381.208 Poultry products offered for for a period not to exceed 20 days when entry and entered to be handled found by any authorized representative and transported as domestic; entry of the Secretary upon any premises into official establishments; trans- where it is held for purposes of, or dur- portation. ing or after distribution in commerce (a) All poultry products, after entry or otherwise subject to the Act, and into the United States in compliance there is reason to believe that any such

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poultry or other article is adulterated § 381.213 Notification of governmental or misbranded and is capable of use as authorities having jurisdiction over human food or has not been inspected, article detained; form of written no- in violation of the provisions of the tification. Act, any other Federal law, or the laws Within 48 hours after the detention of of any State or territory, or the Dis- any poultry or other article pursuant trict of Columbia; or that it has been to § 381.211, an authorized representa- or is intended to be distributed in vio- tive of the Secretary shall give oral or lation of the provisions of the Act, any written notification of such detention other Federal law, or the laws of any to any Federal authorities not con- State or territory, or the District of nected with the Inspection Service, and Columbia. any State or other governmental au- § 381.211 Method of detention; form of thorities, having jurisdiction over such detention tag. article. In the event notification is given orally, it shall be confirmed in An authorized representative of the writing, as promptly as circumstances Secretary shall detain any poultry or permit. other article to be detained under this subpart, by affixing an official ‘‘U.S. § 381.214 Movement of poultry or other Detained’’ tag (FSIS Form 8400–2) to article detained; removal of official such article. marks. [55 FR 47843, Nov. 16, 1990] (a) No poultry or other article detained in accordance with the provi- § 381.212 Notification of detention to sions in this subpart shall be moved by the owner of the poultry or other any person from the place at which it article, or the owner’s agent, and person having custody. is located when so detained, until released by an authorized representative (a) When any poultry or other article of the Secretary: Provided, That any is detained under this Subpart, an au- such article may be moved from the thorized representative of the Sec- place at which it is located when so de- retary shall: tained, for refrigeration or freezing, or (1) Orally notify the immediate cus- storage purposes if such movement has todian of the poultry or other article been approved by an authorized rep- detained, and resentative of the Secretary and the (2) Promptly furnish a copy of a com- article so moved will be further de- pleted ‘‘Notice of Detention’’ (FSIS tained by an authorized representative Form 8080–1) to the immediate custo- of the Secretary after such movement. dian of the detained poultry or other article. (b) Upon terminating the detention of such article, an authorized rep- (b) If the owner of the detained poultry or other article, or the owner’s resentative of the Secretary shall: agent, is not the immediate custodian (1) Orally notify the immediate cus- at the time of detention and if the todian of the released article, and owner, or owner’s agent, can be (2) Furnish copies of a completed ascertained and notified, an authorized ‘‘Notice of Termination of Detention’’ representative of the Secretary shall (FSIS Form 8400–1) to the persons noti- furnish a copy of the completed ‘‘No- fied when the article was detained. The tice of Detention’’ to the owner, or the notice shall be served by either deliver- owner’s agent. Such copy shall be ing the notice to such persons or by served, as soon as possible, by deliver- certifying and mailing the notice to ing the notification to the owner, or such persons at their last known resi- the owner’s agent, or by certifying and dences or principal offices or places of mailing the notification to the owner, business. or the owner’s agent, at his or her last (c) All official marks may be required known residence or principal office or by such representative to be removed place of business. from such article before it is released [55 FR 47843, Nov. 16, 1990] unless it appears to the satisfaction of

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the representative that the article is ited to forcible assaults on, or other ineligible to retain such marks. terference with, any person while engaged in, or on account of the perform- [37 FR 9706, May 16, 1972, as amended at 55 FR 47843, Nov. 16, 1990] ance of, his official duties under the Act. Criminal provisions with respect § 381.215 Poultry or other articles sub- to gifts or offers of bribes to such per- ject to judicial seizure and con- sons and related offenses are contained demnation. in the general criminal code (18 U.S.C. Any poultry carcass, or part thereof, 201). or any product made wholly or in part from any poultry carcass or part there- Subpart V—Special Provisions for of; except those exempted from the def- Designated States and Terri- inition of a poultry product in § 381.15, tories; Criteria and Procedure or any dead, dying, disabled, or dis- for Designating Establishments eased poultry, that is being trans- With Operations Which Would ported in commerce or is otherwise subject to the Act, or is held for sale in Clearly Endanger the Public the United States after such transpor- Health; Disposition of Poultry tation, is subject to seizure and con- Products Therein demnation, in a judicial proceeding pursuant to section 20 of the Act if § 381.220 Definition of ‘‘State’’. such poultry or other article: For purposes of this subpart, the (a) Is or has been processed, sold, term ‘‘State’’ means any State (includ- transported, or otherwise distributed ing the Commonwealth of Puerto Rico) or offered or received for distribution or organized territory. in violation of the Act; or (b) Is capable of use as human food § 381.221 Designation of States under and is adulterated or misbranded; or paragraph 5(c) of the Act. (c) In any other way is in violation of Each of the following States has been the Act. designated, under paragraph 5(c) of the Act, as a State in which the provisions § 381.216 Procedure for judicial sei- of sections 1 through 4, 6 through 10, zure, condemnation, and disposi- and 12 through 22 of the Act shall apply tion. to operations and transactions wholly Any poultry or other article subject within the State. The Federal provi- to seizure and condemnation under this sions apply, effective on the dates subpart is liable to be proceeded shown below: against and seized and condemned, and Effective date of disposed of, at any time, on an appro- application of priate pleading in any U.S. district States Federal provi- court, or other proper court specified sions in section 21 of the Act, within the ju- Arkansas ...... Jan. 2, 1971. risdiction of which the article is found. California ...... Apr. 1, 1976. Colorado ...... Jan. 2, 1971. Connecticut ...... Oct. 1, 1975. § 381.217 Authority for condemnation Georgia ...... Jan. 2, 1971. or seizure under other provisions of Guam ...... Jan. 21, 1972. law. Hawaii ...... Nov. 1, 1995. Idaho ...... Jan. 2, 1971. The provisions of this subpart relat- Kentucky ...... July 28, 1971. ing to detention, seizure, condemna- Maine ...... Jan. 2, 1971. tion and disposition of poultry or other Maryland ...... Mar. 31, 1991. articles do not derogate from authority Massachusetts ...... Jan. 12, 1976. Michigan ...... Jan. 2, 1971. for retention, condemnation, or seizure Minnesota ...... Do. conferred by other provisions of the Missouri ...... Aug. 18, 1972. Act, or other laws. Nebraska ...... July 28, 1971. Nevada ...... July 1, 1973. New Hampshire ...... Aug. 6, 1978 § 381.218 Criminal offenses. New Jersey ...... Do. The Act contains criminal provisions New York ...... Apr. 10, 1977. North Dakota ...... Jan. 2, 1971. with respect to numerous offenses spec- Northern Mariana Islands ...... Oct. 29, 1979. ified in the Act, including but not lim- Oregon ...... Jan. 2, 1971.

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Effective date of cases that the interconnections are application of such that transfer of inedible poultry States Federal provisions product into the official establishment would be difficult or unusual, and any Pennsylvania ...... Oct. 31, 1971. Puerto Rico ...... Jan. 17, 1972. such transfers are strictly prohibited, Rhode Island ...... Oct. 1, 1981. except as permitted under other provi- South Dakota ...... Jan. 2, 1971. sions of the regulations. It is essential Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 27, 1971. that separation of facilities be main- Washington ...... June 1, 1973. tained to the extent necessary to assure that inedible poultry product does [42 FR 2949, Jan. 14, 1977, as amended at 42 not enter the official establishment FR 13270, Mar. 10, 1977; 43 FR 29269, July 7, contrary to the regulations. 1978; 44 FR 55809, Sept. 28, 1979; 46 FR 43829, (c) Sections 381.49 and 381.51 shall Sept. 1, 1981; 53 FR 20101, June 2, 1988; 55 FR apply to such establishments, except 36609, Sept. 6, 1990; 56 FR 8909, Mar. 4, 1991; 60 that separate facilities for men and FR 49495, Sept. 26, 1995; 60 FR 54414, Oct. 24, 1995] women workers will not be required when the majority of the workers in § 381.222 States designated under the establishment are related by blood paragraph 5(c) of the Act; applica- or marriage, provided that this will not tion of regulations. conflict with municipal or State re- The provisions of the regulations in quirements; and except that separation this part apply to operations and trans- of toilet soil lines from house drainage actions wholly within each State des- lines to a point outside the buildings ignated in § 381.221 under paragraph 5(c) will not be required in existing con- of the Act, except as otherwise pro- struction when positive acting back- vided in this section. (The provisions of flow devices are installed. the regulations apply in all respects to (d) Subpart N of this part shall apply operations and transactions in or for to such establishments except as pro- commerce.) vided in this paragraph (d). (a) Each establishment, located in (1) The operator of each such estab- such a designated State, which is lishment shall, prior to the inaugura- granted inspection required under tion of inspection, identify all labeling § 381.6(b), shall obtain approval of plant and marking devices in use, or pro- drawings as specified in § 381.19 within posed for use (upon the date of inau- 18 months after the designation of the guration of inspection) to the Circuit State becomes effective. The establish- Supervisor in which the establishment ment, including its facilities shall be is located. Temporary approval, pend- placed in compliance with the approved ing formal approval under § 381.132, will drawings as soon as possible, but not to be granted by the Circuit Supervisor exceed 36 months after such designa- for labeling and marking devices that tion becomes effective. Failure to have he determines are neither false nor drawings approved or to bring the es- misleading, provided the official in- tablishment into compliance with such spection legend bearing the official es- drawings within the time periods speci- tablishment number is applied to the fied herein will result in the expiration principal display panel of each label, of the grant of inspection. Inspection either by a mechanical printing device will be initially granted to any such es- or a self-destructive pressure sensitive tablishments only if it is found, upon a sticker, and provided the label shows combined evaluation of its premises, the true product name, an accurate in- facilities and operating procedures, to gredient statement, the name and ad- be capable of producing products that dress of the manufacturer, packer, or are not adulterated or misbranded. distributor, and any other features re- (b) Section 381.26 will apply to estab- quired by paragraph 4(h) of the Act. lishments required to have inspection (2) The Circuit Supervisor will for- under § 381.6(b), except that existing ward one copy of each item of labeling interconnections between official and and a description of each marking de- unofficial establishments or between vice for which he has granted tem- official establishments will be per- porary approval to the Washington, mitted if it is determined in specific DC; office of the Labels and Packaging

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Staff and will retain one copy in a tem- erations and transactions solely in or porary approval file for the establish- for intrastate commerce. ment. (3) The operator of the official estab- [37 FR 9706, May 16, 1972, as amended at 39 lishment shall promptly forward a copy FR 4569, Feb. 5, 1974] of each item of labeling and a descrip- § 381.223 Control and disposition of tion of each marking device for which nonfederally inspected poultry temporary approval has been granted products in States designated by the Circuit Supervisor (showing any under paragraph 5(c) of the Act. modifications required by the Circuit Supervisor) to the Labels and Packag- Upon the effective date of designa- ing Staff, Meat and Poultry Inspection tion of a State under paragraph 5(c) of Food Safety and Inspection Service, the Act, no poultry products can be U.S. Department of Agriculture, Wash- processed within the State unless they ington, DC 20250, accompanied by the are prepared under inspection pursuant formula and details of preparation and to the regulations or are exempted packaging for each product. Within 90 from the requirement of inspection days after inauguration of inspection, under § 381.10, and no unexempted poul- all labeling material and marking de- try products which were processed vices temporarily approved by the Cir- without any inspection can lawfully be cuit Supervisor must receive approval distributed within the State. For a peas required by § 381.132 or their use riod of 90 days from the effective date must be discontinued. of such designation, poultry products (4) The Circuit Supervisor will also which were processed in any State list- review all shipping containers to insure ed in § 381.187 and inspected and passed that they do not have any false or mis- under the supervision of a responsible leading labeling and are otherwise not State or local inspection agency or ex- misbranded. Modifications of unaccept- empted from State inspection can be able information on labeling material distributed solely within the State, by the use of pressure sensitive tape of provided they are not adulterated or a type that cannot be removed without misbranded, except that the official in- visible evidence of such removal, or by spection legend shall not be used. Such blocking out with an ink stamp will be authorized on a temporary basis to per- products may not enter official estab- mit the maximum allowable use of all lishments. After said 90-day period, labeling materials on hand. All unac- only federally inspected and passed ceptable labeling material which is not products may be distributed within the modified to comply with the require- designated State, except as provided in ments of the regulations must be de- § 381.10. stroyed or removed from the official establishment. § 381.224 Designation of States under (e) Sections 381.175 through 381.179 section 11 of the Act; application of sections of the Act and the regula- apply to operations and transactions tions. not in or for commerce in a State designated under paragraph 5(c) only if Each of the following States has been the State is also designated under sec- designated, effective on the date shown tion 11 of the Act and if such provisions below, under section 11 of the Act, as a are applicable as shown in § 381.224. State in which the provisions of the (f) Section 381.185(a) will not apply to sections of the Act and regulations States designated under paragraph 5(c) specified below shall apply to operators of the Act. engaged, other than in or for com- (g) Provisions of this part relating to merce, in the kinds of business indi- exports and imports do not apply to op- cated below:

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Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(b): §§ 381.175± Persons engaged (not in or for commerce) in (1) the busi- Arkansas ...... Apr. 1, 1976. 381.178. ness of slaughtering any poultry or processing, freezing, California ...... July 1, 1975. packaging, or labeling any poultry carcasses, or parts or Colorado ...... Oct. 1, 1975. products thereof, for use as human food or animal food; Connecticut ...... Nov. 12, 1976. (2) the business of buying or selling (as a poultry products Georgia ...... Nov. 19, 1976. broker, wholesaler, or otherwise), transporting or storing Guam ...... Nov. 12, 1976. any poultry carcasses, or parts or products thereof; or (3) Idaho ...... Apr. 18, 1973. business as a renderer or in the business of buying, sell- Kentucky ...... Nov. 12, 1976. ing, or transporting any dead, dying, disabled, or diseased Maine ...... Mar. 31, 1991. poultry or parts of carcasses of any poultry that died other- Maryland ...... Jan. 12, 1976. wise than by slaughter. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. North Dakota ...... Oct. 29, 1979. Northern Mariana Jan. 31, 1975. Islands. Oregon ...... May 2, 1974. Pennsylvania ...... Nov. 19, 1976. Puerto Rico ...... Mar. 29, 1982. Rhode Island ...... Nov. 12, 1976. South Dakota ..... Oct. 1, 1975. Tennessee ...... Nov. 19, 1976. Virgin Islands ..... Jan. 31, 1975. Washington ...... Nov. 12, 1976. Act, 11(c); § 381.179 ...... Persons engaged (not in or for commerce) in business as a Arkansas ...... Apr. 1, 1976. poultry products broker; renderer; animal food manufac- California ...... July 1, 1975. turer; wholesaler or public warehouseman of poultry car- Colorado ...... Oct. 1, 1975. casses, or parts or products thereof; or buying, selling, or Connecticut ...... Nov. 12, 1976. transporting dead, dying, disabled, or diseased poultry or Georgia ...... Nov. 19, 1976. parts of carcasses of any poultry that died otherwise than Guam ...... Nov. 12, 1976. by slaughter. Idaho ...... Apr. 18, 1973. Kentucky ...... Nov. 12, 1976. Maine ...... Mar. 31, 1991. Maryland ...... Jan. 12, 1976. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Minnesota ...... Jan. 31, 1975. Missouri ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. North Dakota ...... Oct. 29, 1979. Northern Mariana Jan. 31, 1975. Islands. Oregon ...... May 2, 1974. Pennsylvania ...... Nov. 19, 1976. Puerto Rico ...... Mar. 29, 1982. Rhode Island ...... Nov. 12, 1976. South Dakota ..... Oct. 1, 1975. Tennessee ...... Nov. 19, 1976. Virgin Islands ..... Jan. 31, 1975. Washington ...... Nov. 12, 1976.

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Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(d); 381.194 ...... Persons engaged (not in or for commerce) in the business of Arkansas ...... Nov. 12, 1976. buying, selling or transporting any dead, dying, disabled or Georgia ...... Nov. 19, 1976. diseased poultry, or parts or carcasses of any poultry that Guam ...... Nov. 12, 1976. died otherwise than by slaughter. Idaho ...... Nov. 12, 1976. Maine ...... Mar. 31, 1991. Maryland ...... Nov. 12, 1976. Michigan ...... Oct. 29, 1979. New Hampshire Oct. 29, 1979. Northern Mariana Nov. 19, 1976. Islands. Puerto Rico ...... Mar. 29, 1982. Rhode Island ...... Nov. 12, 1976. South Dakota ..... Nov. 19, 1976. Virgin Islands ..... Nov. 12, 1976.

[37 FR 9706, May 16, 1972] EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 381.224, see the List of CFR Sections Affected in the Finding Aids section of this volume.

§ 381.225 Criteria and procedure for demned under subpart K at official es- designating establishments with op- tablishments; or erations which would clearly en- (iii) It has been prepared, packed or danger the public health; disposi- held under insanitary conditions tion of poultry products therein. whereby it may have become contami- (a) An establishment in any State nated with filth or may have been ren- not listed in § 381.221 that is preparing dered injurious to health (for example, poultry products solely for distribution if insects or vermin are not effectively within such State shall be designated controlled at the establishment, or in- as one producing adulterated products sanitary water is used in preparing which would clearly endanger the pub- poultry products for human food); or lic health, if: (iv) It is, in whole or in part, the (1) Any poultry product processed at product of poultry that died otherwise the establishment is adulterated in any than by slaughter; or of the following respects: (v) Its container is composed, in whole or in part, of any poisonous or (i) It bears or contains a pesticide deleterious substance which may chemical, food additive, or color addi- render the contents injurious to tive, that is ‘‘unsafe’’ within the mean- health; and ing of section 408, 409, or 706 of the Fed- (2) Such adulterated articles are in- eral Food, Drug, and Cosmetic Act or tended to be or are distributed from was intentionally subjected to radi- the establishment while capable of use ation in a manner not permitted under as human food. section 409 of said Act; or if it bears or (b) When any such establishment is contains any other added poisonous or identified by an inspector as one pro- added deleterious substance which may ducing adulterated poultry products render it injurious to health or make it which would clearly endanger public unfit for human food; or health under the criteria in paragraph (ii) It consists in whole or in part of (a) of this section, the following proce- any filthy, putrid or decomposed sub- dure will be followed: stance or is for any other reason un- (1) The inspector will informally ad- sound, unhealthful, unwholesome, or vise the operator of the establishment otherwise unfit for human food (for ex- concerning the deficiencies found by ample, it was prepared from a poultry him and report his findings to the ap- carcass or other ingredients exhibiting propriate Regional Director for the In- spoilage characteristics); or it is, or spection Service. When it is deter- was prepared from, a poultry carcass mined by the Regional Director that which would be required to be con- any establishment preparing poultry

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products solely for distribution within (d) No establishment designated any State is producing adulterated under this section can lawfully prepare poultry products for distribution with- any poultry products unless it first ob- in such State which would clearly en- tains inspection or qualifies for exemp- danger the public health, written noti- tion under § 381.10 of this subpart. All fication thereof will be issued to the other provisions of the regulations appropriate State officials, including shall apply to establishments des- the Governor of the State and the ap- ignated under this section to the same propriate Advisory Committee, for ef- extent and in the same manner as if fective action under State or local law they were engaged in commerce, except to prevent such endangering of the that the exceptions provided for in public health. Such written notifica- § 381.222 shall apply to such establish- tion shall clearly specify the defi- ments. ciencies deemed to result in the production of adulterated poultry products and shall specify a reasonable Subpart W—Rules of Practice time for such action under State or Governing Proceedings Under local law. the Poultry Products Inspec- (2) If effective action is not taken tion Act under State or local law within the specified time, written notification SOURCE: 42 FR 10962, Feb. 25, 1977, unless shall be issued by the Regional Direc- otherwise noted. tor to the operator of the establish- GENERAL ment, specifying the deficiencies involved and allowing him 10 days to § 381.230 Scope and applicability of present his views or make the nec- rules of practice. essary corrections, and notifying him that failure to correct such deficiencies (a) The Uniform Rules of Practice for may result in designation of the estab- the Department of Agriculture promul- lishment and operator thereof as sub- gated in subpart H of part 1, subtitle A, ject to the provisions of sections 1 title 7, Code of Federal Regulations, through 4, 6 through 10, and 12 through are the Rules of Practice applicable to 22 of the Act as though engaged in adjudicatory, administrative proceed- commerce. ings under sections 6, 7, 8(d) and 18 of (3) Thereafter the inspector shall sur- the Poultry Products Inspection Act vey the establishment and designate it (21 U.S.C. 455, 456, 457(d), and 467). In if he determines, in consultation with addition, the Supplemental Rules of the Regional Director, that it is pro- Practice set forth in §§ 381.232 through ducing adulterated poultry products, 381.234 of this Subpart shall be applica- which would clearly endanger the pub- ble to such proceedings. lic health, and formal notice of such (b) The rules of practice set forth in designation will be issued to the opera- §§ 381.235 and 381.236 shall be applicable tor of the establishment by the Re- to the suspension of assignment of in- gional Director. spectors for threats to forcibly assault (c) Poultry products on hand at the or forcible assault, intimidation or in- time of designation of an establish- terference with any inspection service ment under this section are subject to employee pursuant to § 381.29 of the retention or detention, and seizure and regulations (9 CFR 381.29) under the condemnation in accordance with Poultry Products Inspection Act. In § 381.145 or subpart U of this part: Pro- addition, the definitions applicable to vided, That poultry products that have proceedings under the Uniform Rules of been federally inspected and so identi- Practice (7 CFR 1.132) shall apply with fied and that have not been further pre- equal force and effect to proceedings pared at any nonfederally inspected es- under §§ 381.235 and 381.236 of this sub- tablishment may be released for dis- part (9 CFR 381.235 and 381.236). tribution if the products appear to be not adulterated or misbranded at the time of such release.

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SUPPLEMENTAL RULES OF PRACTICE try product as specified in the notice, the Administrator may issue and file a § 381.231 Refusal or withdrawal of in- complaint in accordance with the Uni- spection service under section 18(a) form Rules of Practice. Effective upon of the Act. service of the complaint, inspection If the Administrator has reason to service under the Act shall be with- believe that the applicant for or recipi- drawn from such establishment as pro- ent of service under the Act is unfit to vided in section 18(b) of the Poultry engage in any business requiring such Products Inspection Act (21 U.S.C. inspection because of any of the rea- 467(b)), pending final determination in sons specified in section 18(a) of the the proceeding. Act, he may institute a proceeding by filing a complaint with the Hearing § 381.233 Withholding use of marking, Clerk, who shall promptly serve a true labeling or containers from use copy thereof upon each respondent, as under section 8 of the Poultry Prod- provided in section 1.147(b) of the Uni- ucts Inspection Act. form Rules of Practice (9 CFR 1.147(b)). (a) In any situation in which the Ad- ministrator determines that any mark- § 381.232 Withdrawal of inspection ing or labeling or size or form of any service for failure of an establishment to destroy any condemned container in use or proposed for use carcass or part thereof or any con- with respect to any article subject to demned poultry product. the Poultry Products Inspection Act is (a) In any situation in which the Ad- false or misleading in any particular, ministrator has reason to believe that he shall notify, in writing, the person, an establishment which receives in- firm, or corporation using or proposing spection service under the Poultry to use such marking, labeling, or con- Products Inspection Act has failed to tainer, that such use shall be withheld destroy any condemned carcass or part unless the marking, labeling, or con- thereof or any condemned poultry tainer is modified in such a manner as product, as required under section 6 of the Administrator may prescribe so the Poultry Products Inspection Act that it would not be false or mislead- (21 U.S.C. 455) and the regulations in ing. this subchapter, he may notify the op- (b) The written notification shall erator of the establishment, orally or briefly set forth the reason for within writing, of the Administrator’s in- holding the use of the marking, label- tent to withdraw (for such period or in- ing, or container, and shall offer the re- definitely as the Administrator deems spondent an opportunity to submit a necessary to effectuate the purposes of written statement by way of answer to the Act) inspection service from the es- the notification and a right to request tablishment, pursuant to section 18(b) a hearing with respect to the merits or of the Act (21 U.S.C. 467(b)), if the es- validity of the withholding action. The tablishment fails to destroy the con- written notification shall be served in demned articles involved, as specified the manner prescribed in § 1.147(b) of in the notification, within three days the Uniform Rules of Practice (7 CFR of the receipt of the notification by the 1.147(B). operator of the establishment. In the (c) Effective upon service of the noti- event of oral notification, a written fication, the use of the marking, label- confirmation shall be given, as prompt- ing, or container shall be withheld, if ly as circumstances permit, the opera- the Administrator so directs. tor of the establishment of the intent (d) If any person, firm, or corporation to withdraw inspection. The written so notified fails to accept the deter- notification or confirmation shall be mination of the Administrator and served upon the operator of the estab- files an answer and requests a hearing, lishment in the manner prescribed in and the Administrator, after review of § 1.147(b) of the Uniform Rules of Prac- the answer, determines the initial de- tice (7 CFR 1.147(b)). termination to be correct, he shall file (b) If any establishment so notified with the Hearing Clerk the notifica- fails to destroy any condemned carcass tion, answer and request for hearing, or part thereof or any condemned poul- which shall constitute the complaint

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and answer in the proceeding, which RULES APPLICABLE TO THE SUSPENSION shall thereafter be governed by the OF THE ASSIGNMENT OF INSPECTORS Uniform Rules of Practice. FOR THREATS TO FORCIBLY ASSAULT OR FORCIBLE ASSAULT, INTIMIDATION § 381.234 Refusal or withdrawal of in- OR INTERFERENCE WITH ANY INSPEC- spection service under the Poultry TION SERVICE EMPLOYEE Products Inspection Act for failure to comply with requirements as to § 381.235 Notification to operator of es- premises, facilities, equipment, or tablishment of incident. the operation thereof. In any situation in which a super- (a) In any situation in which the Ad- visor of an inspection service employee ministrator determines that the condi- determines that the operator of any of- tions of an establishment which is ap- ficial establishment or any subsidiary plying for inspection or receives in- therein, or any officer, employee, or spection under the Poultry Products agent of any such operator or any subsidiary therein, acting within the scope Inspection Act are such that there is a of his office, employment, or agency, failure to comply with any require- has threatened to forcibly assault or ments as to premises, facilities, equip- has forcibly assaulted, intimidated or ment, or the operation thereof, as pro- interfered with any inspection service vided in section 7 of the Act (21 U.S.C. employee, under his supervision, in or 456) and the regulations issued thereon account of the performance of the under (9 CFR 381.1 et seq.), he shall employee’s official duties under the refuse to render inspection at the es- Poultry Products Inspection Act, he tablishment. The Administrator shall shall notify the operator of the estab- notify the applicant or operator of the lishment, orally or in writing, of the establishment, orally or in writing, as incident in accordance with § 381.29 of promptly as circumstances permit, of the regulations in this subchapter (9 such refusal and the reasons therefor, CFR 381.29). and the action which the Adminis- trator deems necessary to eliminate § 381.236 Procedure upon failure of operator of establishment to take ac- such conditions. In the event of oral tion required by § 381.29 of the reg- notification, written confirmation ulations. shall be given, as promptly as cir- (a) If any operator of an establish- cumstances permit, to the applicant or ment, notified pursuant to § 381.235 (9 operator of the establishment in the CFR 381.235), fails to promptly take manner prescribed in § 1.147(b) of the any of the actions specified in § 381.29 of Uniform Rules of Practice (7 CFR the regulations (9 CFR 381.29), the Ad- 1.147(b)). ministrator may suspend the assign- (b) If any applicant or operator of an ment of inspectors at that establish- establishment so notified fails to take ment, in whole or in part, as the Ad- the necessary action to eliminate the ministrator determines necessary to conditions within the period specified avoid impairment of the effective con- in the notice, the Administrator may duct of inspection service, by notifying issue a complaint in accordance with the operator of the establishment, oral- the Uniform Rules of Practice. Effec- ly or in writing, of such suspension. In tive upon service of the complaint, in- the event of oral notification, a written spection service shall be refused or confirmation shall be given as prompt- withdrawn from such establishment as ly as circumstances permit to the oper- provided in sections 7 and 18(b) of the ator of the establishment. The written Act (21 U.S.C. 456 and 467(b)) pending notification or confirmation shall be final determination in the proceeding. served upon the operator of the establishment in the manner prescribed in

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§ 1.147(b) of the Uniform Rules of Prac- less data are available from the estab- tice (7 CFR 1.147(b)). lishment’s processing authority dem- (b) The written notification or con- onstrating that a longer time period is firmation, specified in paragraph (a) of safe. this section, which shall constitute the (c) Bleeders. Small orifices on a retort complaint in the proceeding, shall through which steam, other gasses, and briefly set forth the reason for the sus- condensate are emitted from the retort pension of the assignment of inspec- throughout the entire thermal process. tors, including allegations of fact (d) Canned product. A poultry food which constitute a basis for the action. product with a water activity above The complaint shall offer the respond- 0.85 which receives a thermal process ent the opportunity to submit a spe- either before or after being packed in a cific written statement by way of an- hermetically sealed container. Unless swer and the right to request a hearing otherwise specified, the term ‘‘prod- with respect to the merits or validity uct’’ as used in this subpart G shall of the suspension action, and shall mean ‘‘canned product.’’ state the time within which answer by (e) Closure technician. The individ- the respondent must be made, which ual(s) identified by the establishment shall not be less than 10 days after as being trained to perform specific service of the complaint. At any time container integrity examinations as re- prior to the close of the hearing, the quired by this subpart and designated complaint may be amended; but, in by the establishment to perform such case of an amendment adding new pro- examinations. visions, the hearing shall, on the re- (f) Code lot. All production of a par- quest of the respondent, be adjourned ticular product in a specific size con- for a period not exceeding 15 days, if tainer marked with a specific con- the judge determines that such an ad- tainer code. journment is necessary to avoid prejudice to the respondent. (g) Come-up time. The elapsed time, (c) A copy of the complaint served including venting time (if applicable), upon the respondent shall be filed with between the introduction of the heat- the Hearing Clerk who shall assign the ing medium into a closed retort and matter a docket number. the start of process timing. (d) After the complaint is served (h) Critical factor. Any characteristic, upon the respondent, as provided in condition or aspect of a product, con- paragraphs (a) and (b) of this section, tainer, or procedure that affects the the proceeding shall thereafter be con- adequacy of the process schedule. Criti- ducted in accordance with rules of cal factors are established by process- practice which shall be adopted for the ing authorities. proceeding. (i) Headspace. That portion of a container not occupied by the product. Subpart X—Canning and Canned (1) Gross headspace. The vertical dis- Products tance between the level of the product (generally the liquid surface) in an up- SOURCE: 51 FR 45634, Dec. 19, 1986, unless right rigid container and the top edge otherwise noted. of the container (i.e., the flange of an unsealed can, the top of the double § 381.300 Definitions. seam on a sealed can, or the top edge of (a) Abnormal container. A container an unsealed jar). with any sign of swelling or product (2) Net headspace. The vertical dis- leakage or any evidence that the con- tance between the level of the product tents of the unopened container may be (generally the liquid surface) in an up- spoiled. right rigid container and the inside (b) Acidified low acid product. A surface of the lid. canned product which has been formu- (j) Hermetically sealed containers. Air- lated or treated so that every compo- tight containers which are designed nent of the finished product has a pH of and intended to protect the contents 4.6 or lower within 24 hours after the against the entry of microorganisms completion of the thermal process un- during and after thermal processing.

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(1) Rigid container. A container, the who is authorized by the Secretary to shape or contour of which, when filled do any work or perform any duty in and sealed, is neither affected by the connection with the Program (see enclosed product nor deformed by ex- § 301.2(f)). ternal mechanical pressure of up to 10 (s) Retort. A pressure vessel designed pounds per square inch gauge (0.7 kg/ for thermal processing of product cm2) (i.e., normal firm finger pressure). packed in hermetically sealed contain- (2) Semirigid container. A container, ers. the shape or contour of which, when (t) Seals. Those parts of a semirigid filled and sealed, is not significantly container and lid or of a flexible con- affected by the enclosed product under tainer that are fused together in order normal atmospheric temperature and to hermetically close the container. pressure, but can be deformed by exter- (u) Shelf stability. The condition nal mechanical pressure of less than 10 achieved by application of heat, suffi- pounds per square inch gauge (0.7 kg/ cient, alone or in combination with cm2) (i.e., normal firm finger pressure). other ingredients and/or treatments, to (3) Flexible container. A container, the shape or contour of which, when filled render the product free of microorga- and sealed, is significantly affected by nisms capable of growing in the prod- the enclosed product. uct at nonrefrigerated conditions (over ° ° (k) Incubation tests. Tests in which 50 F or 10 C) at which the product is the thermally processed product is intended to be held during distribution kept at a specific temperature for a and storage. Shelf stability and shelf specified period of time in order to de- stable are synonymous with commer- termine if outgrowth of microorga- cial sterility and commercially sterile, nisms occurs. respectively. (l) Initial temperature. The tempera- (v) Thermal process. The heat treat- ture, determined at the initiation of a ment necessary to achieve shelf stabil- thermal process cycle, of the contents ity as determined by the establish- of the coldest container to be proc- ment’s processing authority. It is essed. quantified in terms of: (m) Low acid product. A canned prod- (1) Time(s) and temperature(s); or uct in which any component has a pH (2) Minimum product temperature. value above 4.6. (w) Venting. The removal of air from (n) Process schedule. The thermal a retort before the start of process tim- process and any specified critical fac- ing. tors for a given canned product re- (x) Water activity. The ratio of the quired to achieve shelf stability. water vapor pressure of the product to (o) Process temperature. The minimum the vapor pressure of pure water at the temperature(s) of the heating medium same temperature. to be maintained as specified in the process schedule. § 381.301 Containers and closures. (p) Process time. The intended time(s) a container is to be exposed to the (a) Examination and cleaning of empty heating medium while the heating me- containers. (1) Empty containers, clo- dium is at or above the process tem- sures, and flexible pouch roll stock perature(s). shall be evaluated by the establish- (q) Processing authority. The person(s) ment to ensure that they are clean and or organization(s) having expert knowl- free of structural defects and damage edge of thermal processing require- that may affect product or container ments for foods in hermetically sealed integrity. Such an examination should containers, having access to facilities be based upon a statistical sampling for making such determinations, and plan. designated by the establishment to per- (2) All empty containers, closures, form certain functions as indicated in and flexible pouch roll stock shall be this subpart. stored, handled, and conveyed in such a (r) Program employee. Any inspector manner that will prevent soiling and or other individual employed by the damage that could affect the hermetic Department or any cooperating agency condition of the sealed container.

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(3) Just before filling, rigid contain- the packer’s end during each regular ers shall be cleaned to prevent incorpo- examination period. Examination re- ration of foreign matter into the fin- sults along with any necessary correc- ished product. Closures, semirigid con- tive actions, such as adjusting or re- tainers, preformed flexible pouches, pairing the closing machine, shall be and flexible pouch roll stock contained promptly recorded by the closure tech- in original wrappings do not need to be nician. The establishment shall have cleaned before use. container specification guidelines for (b) Closure examinations for rigid con- double seam integrity on file and avail- tainers (cans). (1) Visual examinations. able for review by Program employees. A closure technician shall visually ex- A teardown examination of the can amine the double seams formed by maker’s end shall be performed on at each closing machine head. When seam least one container selected from each defects (e.g., cutovers, sharpness, closing machine during each examina- knocked down flanges, false seams, tion period except when teardown ex- droops) are observed, necessary correc- aminations are made on incoming tive actions, such as adjusting or re- empty containers or when, in the case pairing the closing machine, shall be of self-manufactured containers, the taken. In addition to the double seams, containers are made in the vicinity of the entire container shall be examined the establishment and the container for product leakage or obvious defects. plant records are made available to A visual examination shall be per- Program employees. Additional tear- formed on at least one container from down examinations on the packer’s end each closing machine head, and the ob- should be made at the beginning of pro- servations, along with any corrective duction, immediately following every actions, shall be recorded. Visual ex- jam in a closing machine and after aminations shall be recorded. Visual closing machine adjustment (including examinations shall be conducted with adjustment for a change in container sufficient frequency to ensure proper size). The following procedures shall be closure and should be conducted at used in teardown examinations of dou- least every 30 minutes of continuous ble seams: closing machine operation. Additional (i) One of the following two methods visual examinations shall be made by shall be employed for dimensional the closure technician at the beginning measurements of the double seam. of production, immediately following (a) Micrometer measurement. For cylin- every jam in the closing machine and drical containers, measure the follow- after closing machine adjustment (in- ing dimensions (Figure 1) at three cluding adjustment for changes in con- points approximately 120 degrees apart tainer size). on the double seam excluding and at (2) Teardown examinations. Teardown least one-half inch from the side seam examinations of double seams formed juncture: by each closing machine head shall be (1) Double seam length—W; performed by a closure technician at a frequency sufficient to ensure proper (2) Double seam thickness—S; closure. These examinations should be (3) Body hook length—BH; and made at intervals of not more than 4 (4) Cover hook length—CH. hours of continuous closing machine Maximum and minimum values for operation. At least one container from each dimensional measurement shall each closing head shall be examined on be recorded by the closure technician.

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the adequacy of the closures formed by each closing machine. When closure defects, such as loose or cocked caps, fractured or cracked containers and low vacuum jars, are observed, necessary corrective actions, such as adjusting or repairing the closing machine, shall be taken and recorded. In addition to the closures, the entire container shall be examined for defects. Visual examinations shall be made with sufficient frequency to ensure proper closure and should be conducted at least every 30 minutes of continuous closing machine operation. Ad- ditional visual examinations shall be made by the closure technician and the observations recorded at the beginning of production, immediately following every jam in the closing machine, and after closing machine adjustment (including adjustment for a change in container size). (b) Seamscope or seam projector. Re- (2) Closure examinations and tests. De- quired measurements of the seam in- pending upon the container and clo- clude thickness, body hook, and over- sure, tests shall be performed by a clo- lap. Seam thickness shall be obtained sure technician at a frequency suffi- by micrometer. For cylindrical con- cient to ensure proper closure. These tainers, at least two locations, exclud- examinations should be made either ing the side seam juncture, shall be before or after thermal processing and used to obtain the required measure- at intervals of not more than 4 hours of ments. (ii) Seam tightness. Regardless of the continuous closing machine operation. dimensional measurement method used At least one container from each clos- to measure seam dimensions, at a mining machine shall be examined during imum, the seam(s) examined shall be each regular examination period. Ex- stripped to assess the degree of wrin- amination results along with any nec- kling. essary corrective actions, such as ad- (iii) Side seam juncture rating. Regard- justing or repairing the closing ma- less of the dimensional measurement chine, shall be promptly recorded by method used to measure seam dimen- the closure technician. The establish- sions, the cover hook shall be stripped ment shall have specification guide- to examine the cover hook droop at the lines for closure integrity on file and juncture for containers having side available for review by Program em- seams. ployees. Additional closure examina- (iv) Examination of noncylindrical con- tions should be made at the beginning tainers. Examination of noncylindrical of production, immediately following containers (e.g., square, rectangular, every jam in the closing machine and ‘‘D’’-shaped, and irregularly-shaped) after closing machine adjustment (in- shall be conducted as described in para- cluding adjustment for a change in graphs (b)(2) (i), (ii), and (iii) of this container size). section except that the required dimen- (d) Closure examinations for semirigid sional measurements shall be made on and flexible containers—(1) Heat seals— the double seam at the points listed in (i) Visual examinations. A closure tech- the establishment’s container speci- nician shall visually examine the seals fication guidelines. formed by each sealing machine. When (c) Closure examinations for glass con- sealing defects are observed, necessary tainers. (1) Visual examinations. A clo- corrective actions, such as adjusting or sure technician shall visually assess repairing the sealing machine, shall be

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taken and recorded. In addition to ex- stability. A longer period of time be- amining the heat seals, the entire con- tween closing and the initiation of tainer shall be examined for product thermal processing may be permitted leakage or obvious defects. Visual ex- by the Administrator. aminations shall be performed before (Approved by the Office of Management and and after the thermal processing oper- Budget under control number 0583–0015) ation with sufficient frequency to ensure proper closure. These examina- § 381.302 Thermal processing. tions should be conducted at least in (a) Process schedules. Prior to the accordance with a statistical sampling processing of canned product for dis- plan. All defects noted and corrective tribution in commerce, an establish- actions taken shall be promptly re- ment shall have a process schedule (as corded. defined in § 381.300(n) of this subpart) (ii) Physical tests. Tests determined for each canned poultry product to be by the establishment as necessary to packed by the establishment. assess container integrity shall be con- (b) Source of process schedules. (1) ducted by the closure technician at a Process schedules used by an establish- frequency sufficient to ensure proper ment shall be developed or determined closure. These tests shall be performed by a processing authority. after the thermal processing operation (2) Any change in product formula- and should be made at least every 2 tion, ingredients, or treatments that hours of continuous production. The are not already incorporated in a proc- establishment’s acceptance guidelines ess schedule and that may adversely af- for each test procedure shall be on file fect either the product heat penetra- and available for review by Program tion profile or sterilization value re- employees. Test results along with any quirements shall be evaluated by the necessary corrective actions, such as establishment’s processing authority. adjusting or repairing the sealing ma- If it is determined that any such chine, shall be recorded. change adversely affects the adequacy (2) Double seams on semirigid or of the process schedule, the processing flexible containers shall be examined authority shall amend the process and the results recorded as provided in schedule accordingly. paragraph (b) of this section. Any addi- (3) Complete records concerning all tional measurements specified by the aspects of the development or deter- container manufacturer shall also be mination of a process schedule, includ- made and recorded. ing any associated incubation tests, (e) Container coding. Each container shall be made available by the estab- shall be marked with a permanent, leg- lishment to the Program employee ible, identifying code mark. The mark upon request. shall, at a minimum, identify in code (c) Submittal of process information. (1) the product (unless the product name Prior to the processing of canned prod- is lithographed or printed elsewhere on uct for distribution in commerce, the the container) and the day and year establishment shall provide the inspec- the product was packed. tor at the establishment with a list of (f) Handling of containers after closure. the process schedules (including alter- (1) Containers and closures shall be nate schedules) along with any addi- protected from damage which may tional applicable information, such as cause defects that are likely to affect the retort come-up operating proce- the hermetic condition of the contain- dures and critical factors. ers. The accumulation of stationary (2) Letters or other written commu- containers on moving conveyors should nications from a processing authority be minimized to avoid damage to the recommending all process schedules containers. shall be maintained on file by the es- (2) The maximum time lapse between tablishment. Upon request by Program closing and initiation of thermal proc- employees, the establishment shall essing shall be 2 hours. However, the make available such letters or written Administrator may specify a shorter communications (or copies thereof). If period of time when considered nec- critical factors are identified in the essary to ensure product safety and process schedule, the establishment

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shall provide the inspector with a copy § 381.304 Operations in the thermal of the procedures for measuring, con- processing area. trolling, and recording these factors, (a) Posting of processes. Process sched- along with the frequency of such meas- ules (or operating process schedules) urements, to ensure that the critical for daily production, including mini- factors remain within the limits used mum initial temperatures and operat- to establish the process schedule. Once ing procedures for thermal processing submitted, the process schedules and equipment, shall be posted in a con- associated critical factors and the pro- spicuous place near the thermal proc- cedures for measuring (including the essing equipment. Alternatively, such frequency), controlling, and recording information shall be available to the of critical factors shall not be changed thermal processing system operator without the prior written submittal of and the inspector. the revised procedures (including sup- (b) Process indicators and retort traffic porting documentation) to the inspec- control. A system for product traffic tor at the establishment. control shall be established to prevent product from bypassing the thermal (Approved by the Office of Management and processing operation. Each basket, Budget under control number 0583–0015) crate or similar vehicle containing unprocessed product, or at least one visi- § 381.303 Critical factors and the appli- ble container in each vehicle, shall be cation of the process schedule. plainly and conspicuously marked with Critical factors specified in the proc- a heat sensitive indicator that will vis- ess schedule shall be measured, con- ually indicate whether such unit has trolled and recorded by the establish- been thermally processed. Exposed ment to ensure that these factors re- heat sensitive indicators attached to main within the limits used to estab- container vehicles shall be removed be- lish the process schedule. Examples of fore such vehicles are refilled with un- factors that are often critical to proc- processed product. Container loading ess schedule adequacy may include: systems for crateless retorts shall be (a) General. (1) Maximum fill-in designed to prevent unprocessed prod- weight or drained weight; uct from bypassing the thermal proc- (2) Arrangement of pieces in the con- essing operation. tainer; (c) Initial temperature. The initial (3) Container orientation during ther- temperature of the contents of the coldest container to be processed shall mal processing; be determined and recorded by the es- (4) Product formulation; tablishment at the time the processing (5) Particle size; cycle begins to assure that the tem- (6) Maximum thickness for flexible, perature of the contents of every con- and to some extent semirigid contain- tainer to be processed is not lower than ers during thermal processing; the minimum initial temperature spec- (7) Maximum pH; ified in the process schedule. Thermal (8) Percent salt; processing systems which subject the (9) Ingoing (or formulated) nitrite filled and sealed containers to water at level (ppm); any time before process timing begins (10) Maximum water activity; and shall be operated to assure that such (11) Product consistency or viscosity. water will not lower the temperature (b) Continuous rotary and batch agitat- of the product below the minimum ini- ing retorts. (1) Minimum headspace; and tial temperature specified in the proc- (2) Retort reel speed. ess schedule. (d) Timing devices. Devices used to (c) (1) Chain or Hydrostatic retorts. time applicable thermal processing op- conveyor speed. eration functions or events, such as (d) Steam/air retorts. (1) Steam/air process schedule time, come-up time ratio; and and retort venting, shall be accurate to (2) Heating medium flow rate. assure that all such functions or events (Approved by the Office of Management and are achieved. Pocket watches and wrist Budget under control number 0583–0015) watches are not considered acceptable

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timing devices. Analog and digital tors. Any such device that is approved clocks are considered acceptable. If shall, upon installation and at least such clocks do not display seconds, all once a year thereafter, be tested for ac- required timed functions or events curacy against a known accurate shall have at least a 1-minute safety standard. Records that specify the factor over the specified thermal proc- date, standard used, test method, and essing operation times. Temperature/ the person or testing authority per- time recording devices shall correspond forming the test shall be maintained within 15 minutes to the time of the on file by the establishment and made day recorded on written records re- available to Program employees. Any quired by § 381.306. such device which cannot be adjusted (e) Measurement of pH. Unless other to the standard shall be replaced, or re- methods are approved by the Adminis- paired and tested for accuracy before trator, potentiometric methods using further use. electronic instruments (pH meters) (2) Temperature/time recording devices. shall be used for making pH determina- Each thermal processing system shall tions when a maximum pH value is be equipped with at least one tempera- specified as a critical factor in a proc- ture/time recording device to provide a ess schedule. permanent record of temperatures § 381.305 Equipment and procedures within the thermal processing system. for heat processing systems. This recording device may be combined with the steam controller and may be a (a) Instruments and controls common to recording/controlling instrument. different thermal processing systems—(1) When compared to the known accurate Indicating temperature devices. Each retort shall be equipped with at least one indicating temperature device, the re- indicating temperature device that cording accuracy shall be equal to or ° ° measures the actual temperature with- better than 1 F (or 0.5 C) at the proc- in the retort. The indicating tempera- ess temperature. The temperature re- ture device, not the temperature/time cording chart should be adjusted to recording device, shall be used as the agree with, but shall never be higher reference instrument for indicating the than, the known accurate indicating process temperature. temperature device. A means of pre- (i) Mercury-in-glass thermometers. A venting unauthorized changes in the mercury-in-glass thermometer shall adjustment shall be provided. For ex- have divisions that are readable to 1 °F ample, a lock or a notice from manage- (or 0.5 °C) and whose scale contains not ment posted at or near the recording more than 17 °F/inch (or 4.0 °C/cm) of device warning that only authorized graduated scale. Each mercury-in-glass persons are permitted to make adjust- thermometer shall be tested for accu- ments, are satisfactory means for pre- racy against a known accurate stand- venting unauthorized changes. Air-op- ard upon installation and at least once erated temperature controllers shall a year to ensure its accuracy. Records have adequate filter systems to ensure that specify the date, standard used, a supply of clean, dry air. The recorder test method, and the person or testing timing mechanism shall be accurate. authority performing the test shall be (i) Chart-type devices. Devices using maintained on file by the establish- charts shall be used only with the cor- ment and made available to Program rect chart. Each chart shall have a employees. A mercury-in-glass ther- working scale of not more than 55 °F/ mometer that has a divided mercury inch (or 12 °C/cm) within a range of 20 column or that cannot be adjusted to °F (or 11 °C) of the process tempera- the standard shall be repaired and test- ture. Chart graduations shall not ex- ed for accuracy before further use, or ceed 2 °F (or 1 °C) within a range of 10 replaced. °F (or 5 °C) of the process temperature. (ii) Other devices. In lieu of mercury- Multipoint plotting chart-type devices in-glass thermometers, the Adminis- shall print temperature readings at in- trator, upon request, will consider tervals that will assure that the pa- other indicating temperature devices, rameters of the process time and proc- such as resistance temperature detec- ess temperature have been met. The

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frequency of recording should not ex- employ bottom retort crate supports. ceed 1-minute intervals. Baffle plates shall not be used in the (ii) Other devices. In lieu of chart-type bottom of retorts. devices, the Administrator will con- (v) Steam spreader. Perforated steam sider for approval other recording de- spreaders, if used, shall be maintained vices upon request. to ensure they are not blocked or oth- (3) Steam controllers. Each retort shall erwise inoperative. Horizontal still re- be equipped with an automatic steam torts shall be equipped with perforated controller to maintain the retort tem- steam spreaders that extend the full perature. This may be a recording/con- length of the retort unless the ade- trolling instrument when combined quacy of another arrangement is docu- with a temperature/time recording de- mented by heat distribution data or vice. other documentation from a processing (4) Air valves. All air lines connected authority. Such information shall be to the retorts designed for pressure maintained on file by the establish- processing in steam shall be equipped ment and made available to Program with a globe valve or other equivalent- employees for review. type valve or piping arrangement that (vi) Bleeders and condensate removal. will prevent leakage of air into the re- Bleeders, except those for external tort during the process cycle. wells of temperature devices, shall (5) Water valves. All retort water lines have 1⁄8 inch (or 3 mm) or larger open- that are intended to be closed during a ings and shall be wide open during the process cycle shall be equipped with a entire process including the come-up globe valve or other equivalent-type time. For horizontal still retorts, valve or piping arrangement that will bleeders shall be located within ap- prevent leakage of water into the re- proximately 1 foot (or 30 cm) of the tort during the process cycle. outermost locations of containers at (b) Pressure processing in steam—(1) each end along the top of the retort. Batch still retorts. (i) The basic require- Additional bleeders shall be located ments and recommendations for indi- not more than 8 feet (2.4 m) apart along cating temperature devices and tem- the top. Bleeders may be installed at perature/time recording devices are depositions other than those specified scribed in paragraphs (a) (1) and (2) of above, as long as the establishment has this section. Additionally, bulb sheaths heat distribution data or other docu- or probes of indicating temperature de- mentation from the manufacturer or vices and probes of temperature/time from a processing authority dem- recording devices shall be installed ei- onstrating that the bleeders accom- ther within the retort shell or in exter- plish removal of air and circulate the nal wells attached to the retort. Exter- steam within the retort. This informa- nal wells shall be connected to the re- tion shall be maintained on file by the tort through at least a 3⁄4 inch (1.9 cm) establishment and made available to diameter opening and equipped with a Program employees for review. All 1⁄16 inch (1.6 mm) or larger bleeder bleeders shall be arranged in a way opening so located as to provide a con- that enables the retort operator to ob- stant flow of steam past the length of serve that they are functioning prop- the bulb or probe. The bleeder for ex- erly. Vertical retorts shall have at ternal wells shall emit steam continu- least one bleeder opening located in ously during the entire thermal proc- the portion of the retort opposite the essing period. steam inlet. All bleeders shall be ar- (ii) Steam controllers are required as ranged so that the retort operator can described in paragraph (a)(3) of this observe that they are functioning prop- section. erly. In retorts having a steam inlet (iii) Steam inlet. The steam inlet to above the level of the lowest container, each retort shall be large enough to a bleeder shall be installed in the bot- provide steam for proper operation of tom of the retort to remove conden- the retort, and shall enter at a point to sate. The condensate bleeder shall be facilitate air removal during venting. so arranged that the retort operator (iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be

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checked with sufficient frequency to made available to Program employees ensure adequate removal of conden- for review. sate. Visual checks should be per- (ix) Vents. (a) Vents shall be located formed at intervals of not more than 15 in that portion of the retort opposite minutes and the results recorded. the steam inlet and shall be designed, Intermittent condensate removal sys- installed, and operated in such a way tems shall be equipped with an auto- that air is removed from the retort be- matic alarm system that will serve as fore timing of the thermal process is a continuous monitor of condensate started. Vents shall be controlled by a bleeder functioning. The automatic gate, plug cock, or other full-flow valve alarm system shall be tested at the be- which shall be fully opened to permit ginning of each shift for proper func- rapid removal of air from retorts dur- tioning and the results recorded. If the ing the venting period. alarm system is not functioning prop- (b) Vents shall not be connected to a erly, it must be repaired before the re- closed drain system without an atmos- tort is used. pheric break in the line. Where a retort (vii) Stacking equipment. (a) Equip- manifold connects several pipes from a ment for holding or stacking contain- single retort, the manifold shall be ers in retorts. Crates, trays, gondolas, controlled by a gate, plug cock, or carts, and other vehicles for holding or other full-flow valve and the manifold stacking product containers in the re- shall be of a size such that the cross- tort shall be so constructed to ensure sectional area of the manifold is larger steam circulation during the venting, than the total cross-sectional area of come-up, and process times. The bot- all connecting vents. The discharge tom of each vehicle shall have perfora- shall not be connected to a closed drain tions at least 1 inch (2.5 cm) in diame- without an atmospheric break in the ter on 2 inch (or 5 cm) centers or the line. A manifold header connecting equivalent unless the adequacy of an- vents or manifolds from several still other arrangement is documented by retorts shall lead to the atmosphere. heat distribution data or other docu- The manifold header shall not be con- mentation from a processing authority trolled by a valve and shall be of a size and such information is maintained on such that the cross-sectional area is at file by the establishment and made least equal to the total cross-sectional available to Program employees for re- area of all connecting retort manifold view. pipes from the maximum number of re- (b) Divider plates. Whenever one or torts to be vented simultaneously. more divider plates are used between (c) Some typical installations and op- any two layers of containers or placed erating procedures are described below. on the bottom of a retort vehicle, the Other retort installations, vent piping establishment shall have on file docu- arrangements, operating procedures or mentation that the venting procedure auxiliary equipment such as divider allows the air to be removed from the plates may be used provided there is retort before timing of the thermal documentation that the air is removed process is started. Such documentation from the retort before the process is shall be in the form of heat distribu- started. Such documentation shall be tion data or documentation from a in the form of heat distribution data or processing authority. This information other documentation from the equip- shall be made available to Program ment manufacturer or processing au- employees for review. thority. This information shall be (viii) Bleeder and vent mufflers. If muf- maintained on file by the establish- flers are used on bleeders or vent sys- ment and made available to Program tems, the establishment shall have on employees for review. file documentation that the mufflers (d) For crateless retort installations, do not impede the removal of air from the establishment shall have heat dis- the retort. Such documentation shall tribution data or other documentation consist of either heat distribution data from the equipment manufacturer or or documentation from the muffler from a processing authority that dem- manufacturer or from a processing au- onstrates that the venting procedure thority. This information shall be used accomplishes the removal of air

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and condensate. This information shall (iii) Venting through water spreaders. be maintained on file by the establishment and made available to Program employees for review. (e) Examples of typical installations and operating procedures that comply with the requirements of this section are as follows: (1) Venting horizontal retorts. (i) Venting through multiple 1 inch (2.5 cm) vents discharging directly to the atmosphere.

Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 21⁄2 inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 11⁄2 inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length 2 inches (or 5 cm). The number of holes shall be such that their total cross-sectional area is equal to the cross-sectional area of the vent pipe inlet. Specifications (Figure 1): One, 1-inch (2.5 cm) Venting method (Figure 3): The gate, plug vent for every 5 feet (1.5 m) of retort length, cock, or other full-flow valve on the water equipped with a gate, plug cock, or other spreader vent shall be wide open for at least full-flow valve and discharging to atmos- ° ° phere. The end vents shall not be more than 5 minutes and to at least 225 F (or 107 C), or for at least 7 minutes and to at least 220 °F 21⁄2 feet (or 75 cm) from ends of retort. ° Venting method (Figure 1): Vent valves shall (or 104.5 C). be wide open for at least 5 minutes and to at (iv) Venting through a single 21⁄2 inch ° ° least 225 F (or 107 C), or at least 7 minutes (6.4 cm) top vent for retorts not exceed- and to at least 220 °F (or 104.5 °C). ing 15 feet (4.6 m) in length. (ii) Venting through multiple 1 inch (2.5 cm) vents discharging through a manifold to the atmosphere.

Specifications (Figure 4): A 21⁄2 inch (6.4 cm) vent equipped with a 21⁄2 inch (6.4 cm) gate, plug cock, or other full-flow valve and lo- Specifications (Figure 2): One, 1-inch (2.5 cm) cated within 2 feet (61 cm) of the center of vent for every 5 feet (1.5 m) of retort length; the retort. 1 vents not over 2 ⁄2 feet (or 75 cm) from ends Venting method (Figure 4): The vent valve of retort; size of manifold for retorts less shall be wide open for at least 4 minutes and 1 than 15 feet (4.6 m) in length, 2 ⁄2 inches (6.4 to at least 220 °F (or 104.5 °C). cm), and for retorts 15 feet (4.6 m) and over in length, 3 inches (7.6 cm). (2) Venting vertical retorts. Venting method (Figure 2): The manifold (i) Venting through a 11⁄2 inch (3.8 cm) vent gate, plug cock, or other full-flow valve overflow. shall be wide open for at least 6 minutes and to at least 225 °F (or 107 °C) or for at least 8 minutes and to at least 220 °F (or 104.5 °C).

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Specifications (Figure 5): A 11⁄2 inch (3.8 cm) overflow pipe equipped with a 11⁄2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11⁄2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header. Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C). (ii) Venting through a single 1 inch (2.5 cm) side or top vent.

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Specifications (Figure 6 or 7): A 1 inch (2.5 available to Program employees for re- cm) vent in lid or top side, equipped with a view. All bleeders shall be arranged in gate, plug cock, or other full-flow valve and a way that enables the retort operator discharging directly into the atmosphere or to a manifold header. to observe that they are functioning Venting method (Figure 6 or 7): The vent properly. valve shall be wide open for at least 5 min- (v) Venting and condensate removal. utes and to at least 230 °F (110 °C), or for at The air in the retort shall be removed least 7 minutes and to at least 220 °F (or 104.5 before processing is started. Heat dis- °C). tribution data or other documentation (2) Batch agitating retorts. (i) The from the manufacturer or from the basic requirements for indicating tem- processing authority who developed the perature devices and temperature/time venting procedure shall be kept on file recording devices are described in para- by the establishment and made avail- graphs (a) (1) and (2) of this section. able to Program employees for review. Additionally, bulb sheaths or probes of At the time the steam is turned on, the indicating temperature devices and drain shall be opened to remove steam probes of temperature/time recording condensate from the retort. A bleeder devices shall be installed either within shall be installed in the bottom of the the retort shell or in external wells at- retort to remove condensate during re- tached to the retort. External wells tort operation. The condensate bleeder shall be connected to the retort shall be so arranged that the retort op- through at least a 3⁄4 inch (1.9 cm) di- erator can observe that it is function- ameter opening and equipped with a 1⁄16 ing properly. The condensate bleeder (1.6 mm) or larger bleeder opening so shall be checked with sufficient fre- located as to provide a constant flow of quency to ensure adequate removal of steam past the length of the bulbs or condensate. Visual checks should be probes. The bleeder for external wells performed at intervals of not more shall emit steam continuously during than 15 minutes and the results re- the entire thermal processing period. corded. Intermittent condensate re- (ii) Steam controllers are required as moval systems shall be equipped with described in paragraph (a)(3) of this an automatic alarm system that will section. serve as a continuous monitor of con- (iii) Steam inlet. The steam inlet to densate bleeder functioning. The auto- each retort shall be large enough to matic alarm system shall be tested at provide steam for proper operation of the beginning of each shift for proper the retort and shall enter at a point(s) functioning and the results recorded. If to facilitate air removal during vent- the alarm system is not functioning ing. properly, it must be repaired before the (iv) Bleeders. Bleeders, except those retort is used. for external wells of temperature de- (vi) Retort or reel speed timing. The re- vices, shall be 1⁄8 inch (or 3 mm) or larg- tort or reel speed shall be checked be- er and shall be wide open during the fore process timing begins and, if need- entire process including the come-up ed, adjusted as specified in the process time. Bleeders shall be located within schedule. In addition, the rotational approximately 1 foot (or 30 cm) of the speed shall be determined and recorded outermost location of containers, at at least once during process timing of each end along the top of the retort. each retort load processed. Alter- Additional bleeders shall be located natively, a recording tachometer can not more than 8 feet (2.4 m) apart along be used to provide a continuous record the top. Bleeders may be installed at of the speed. The accuracy of the re- positions other than those specified cording tachometer shall be deter- above, as long as the establishment has mined and recorded at least once per heat distribution data or other docu- shift by checking the retort or reel mentation from the manufacturer or speed using an accurate stopwatch. A from a processing authority that the means of preventing unauthorized bleeders accomplish removal of air and speed changes on retorts shall be pro- circulate the steam within the retort. vided. For example, a lock or a notice This information shall be maintained from management posted at or near on file by the establishment and made the speed adjustment device warning

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that only authorized persons are per- specified above, as long as the estab- mitted to make adjustments are satis- lishment has heat distribution data or factory means of preventing unauthor- other documentation from the manu- ized changes. facturer or a processing authority that (vii) Bleeder and vent mufflers. If muf- the bleeders accomplish removal of air flers are used on bleeders or vent sys- and circulate the steam within the re- tems, the establishment shall have doc- tort. This information shall be main- umentation that the mufflers do not tained on file by the establishment and impede the removal of air from the re- made available to Program employees tort. Such documentation shall consist for review. All bleeders shall be ar- of either heat distribution data or doc- ranged so that the retort operator can umentation from the muffler manufac- observe that they are functioning prop- turer or from a processing authority. erly. This information shall be maintained (v) Venting and condensate removal. on file by the establishment and made The air in the retort shall be removed available to Program employees for re- before processing is started. Heat dis- view. tribution data or other documentation (3) Continuous rotary retorts. (i) The from the manufacturer or from the basic requirements for indicating tem- processing authority who developed the perature devices and temperature/time venting procedure shall be kept on file recording devices are described in para- by the establishment and made avail- graphs (a) (1) and (2) of this section. able to Program employees for review. Additionally, bulb sheaths or probes of At the time the steam is turned on, the indicating temperature devices and drain shall be opened to remove steam probes of temperature/time recording condensate from the retort. A bleeder devices shall be installed either within shall be installed in the bottom of the the retort shell or in external wells at- shell to remove condensate during the tached to the retort. External wells retort operation. The condensate bleed- shall be connected to the retort er shall be so arranged that the retort through at least a 3⁄4 inch (1.9 cm) di- operator can observe that it is func- ameter opening and equipped with a 1⁄16 tioning properly. The condensate inch (1.6 mm) or larger bleeder opening bleeder shall be checked with sufficient so located as to provide a constant flow frequency to ensure adequate removal of steam past the length of the bulbs or of condensate. Visual checks should be probes. The bleeder for external wells performed at intervals of not more shall emit steam continuously during than 15 minutes and the results re- the entire thermal processing period. corded. Intermittent condensate re- (ii) Steam controllers are required as moval systems shall be equipped with described in paragraph (a)(3) of this an automatic alarm system that will section. serve as a continuous monitor of con- (iii) Steam inlet. The steam inlet to densate bleeder functioning. The auto- each retort shall be large enough to matic alarm system shall be tested at provide steam for proper operation of the beginning of each shift for proper the retort, and shall enter at a point(s) functioning and the results recorded. If to facilitate air removal during vent- the alarm system is not functioning ing. properly, it must be repaired before the (iv) Bleeders. Bleeders, except those retort is used. for external wells of temperature de- (vi) Retort speed timing. The rota- vices, shall be 1⁄8 inch (3.2 mm) or larg- tional speed of the retort shall be spec- er and shall be wide open during the ified in the process schedule. The speed entire process, including the come-up shall be adjusted as specified, and re- time. Bleeders shall be located within corded by the establishment when the approximately 1 foot (or 30 cm) of the retort is started, and checked and re- outermost location of containers at corded at intervals not to exceed 4 each end along the top of the retort. hours to ensure that the correct retort Additional bleeders shall be located speed is maintained. Alternatively, a not more than 8 feet (2.4 m) apart along recording tachometer may be used to the top of the retort. Bleeders may be provide a continuous record of the installed at positions other than those speed. If a recording tachometer is

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used, the speed shall be manually (iv) Bleeders. Bleeder openings 1⁄4 inch checked against an accurate stopwatch (or 6 mm) or larger shall be located in at least once per shift and the results the steam chamber(s) opposite the recorded. A means of preventing unau- point of steam entry. Bleeders shall be thorized speed changes on retorts shall wide open and shall emit steam con- be provided. For example, a lock or a tinuously during the entire process, in- notice from management posted at or cluding the come-up time. All bleeders near the speed adjustment device warn- shall be arranged in such a way that ing that only authorized persons are the operator can observe that they are permitted to make adjustments are functioning properly. satisfactory means of preventing unau- (v) Venting. Before the start of proc- thorized changes. essing operations, the retort steam (vii) Bleeders and vent mufflers. If muf- chamber(s) shall be vented to ensure flers are used on bleeders or vent sys- removal of air. Heat distribution data tems, the establishment shall have doc- or other documentation from the man- umentation that the mufflers do not ufacturer or from a processing author- impede the removal of air from the re- ity demonstrating that the air is retort. Such documentation shall consist moved from the retort prior to process- of either heat distribution data or ing shall be kept on file at the estab- other documentation from the muffler lishment and made available to Pro- manufacturer or from a processing au- gram employees for review. thority. This information shall be (vi) Conveyor speed. The conveyor maintained on file by the establish- speed shall be calculated to obtain the ment and made available to Program required process time and recorded by employees for review. the establishment when the retort is (4) Hydrostatic retorts. (i) The basic restarted. The speed shall be checked and quirements for indicating temperature recorded at intervals not to exceed 4 devices and temperature/time record- hours to ensure that the correct con- ing devices are described in paragraphs veyor speed is maintained. A recording (a) (1) and (2) of this section. Addition- device may be used to provide a contin- ally, indicating temperature devices uous record of the conveyor speed. shall be located in the steam dome near the steam/water interface. Where When a recording device is used, the the process schedule specifies mainte- speed shall be manually checked nance of particular water temperatures against an accurate stopwatch at least in the hydrostatic water legs, at least once per shift by the establishment. A one indicating temperature device means of preventing unauthorized shall be located in each hydrostatic speed changes of the conveyor shall be water leg so that it can accurately provided. For example, a lock or a no- measure water temperature and be eas- tice from management posted at or ily read. The temperature/time re- near the speed adjustment device warn- corder probe shall be installed either ing that only authorized persons are within the steam dome or in a well at- permitted to make adjustments are tached to the dome. Each probe shall satisfactory means of preventing unau- have a 1⁄16 inch (1.6 mm) or larger bleed- thorized changes. er opening which emits steam continu- (vii) Bleeders and vent mufflers. If muf- ously during the processing period. Ad- flers are used on bleeders or vent sys- ditional temperature/time recorder tems, the establishment shall have doc- probes shall be installed in the hydro- umentation that the mufflers do not static water legs if the process sched- impede the removal of air from the re- ule specifies maintenance of particular tort. Such documentation shall consist temperatures in these water legs. of either heat distribution data or (ii) Steam controllers are required as other documentation from the muffler described in paragraph (a)(3) of this manufacturer or from a processing au- section. thority. This information shall be (iii) Steam inlet. The steam inlets maintained on file by the establish- shall be large enough to provide steam ment and made available to Program for proper operation of the retort. employees for review.

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(c) Pressure processing in water—(1) the process schedule and that the con- Batch still retorts. (i) The basic require- tainers do not become displaced and ments for indicating temperature de- overlap or rest on one another during vices and temperature/time recording the thermal process. devices are described in paragraphs (vii) Drain valve. A nonclogging, (a)(1) and (2) of this section. Addition- water-tight drain valve shall be used. ally, bulbs or probes of indicating tem- Screens shall be installed over all drain perature devices shall be located in openings. such a position that they are beneath (viii) Water level. There shall be a the surface of the water throughout means of determining the water level the process. On horizontal retorts, the in the retort during operation (i.e., by indicating temperature device bulb or using a gauge, electronic sensor, or probe shall be inserted directly into sight glass indicator). For retorts re- the retort shell. In both vertical and quiring complete immersion of con- horizontal retorts, the indicating temperature device bulb or probe shall ex- tainers, water shall cover the top layer tend directly into the water a mini- of containers during the entire come- mum of 2 inches (or 5 cm) without a up time and thermal processing periods separable well or sleeve. In vertical re- and should cover the top layer of con- torts equipped with a recorder/control- tainers during cooling. For retorts ler, the controller probe shall be lo- using cascading water or water sprays, cated at the bottom of the retort below the water level shall be maintained the lowest crate rest in such a position within the range specified by the retort that the steam does not strike it di- manufacturer or processing authority rectly. In horizontal retorts so during the entire come-up, thermal equipped, the controller probe shall be processing, and cooling periods. A located between the water surface and means to ensure that water circulation the horizontal plane passing through continues as specified throughout the the center of the retort so that there is come-up, thermal processing, and cool- no opportunity for direct steam im- ing periods shall be provided. The re- pingement on the controller probe. Air- tort operator shall check and record operated temperature controllers shall the water level at intervals to ensure it have filter systems to ensure a supply meets the specified processing param- of clean, dry air. eters. (ii) Pressure recording device. Each re- (ix) Air supply and controls. In both tort shall be equipped with a pressure horizontal and vertical still retorts, a recording device which may be com- means shall be provided for introducing bined with a pressure controller. compressed air or steam at the pres- (iii) Steam controllers are required sure required to maintain container in- as described in paragraph (a)(3) of this tegrity. Compressed air and steam section. entry shall be controlled by an auto- (iv) Heat distribution. Heat distribu- matic pressure control unit. A non- tion data or other documentation from return valve shall be provided in the the equipment manufacturer or a processing authority demonstrating uni- air supply line to prevent water from form heat distribution within the re- entering the system. Overriding air or tort shall be kept on file at the estab- steam pressure shall be maintained lishment and made available to Pro- continuously during the come-up, ther- gram employees for review. mal processing, and cooling periods. If (v) Crate supports. A bottom crate air is used to promote circulation, it support shall be used in vertical re- shall be introduced into the steam line torts. Baffle plates shall not be used in at a point between the retort and the the bottom of the retort. steam control valve at the bottom of (vi) Stacking equipment. For filled the retort. The adequacy of the air cir- flexible containers and, where applica- culation for maintaining uniform heat ble, semirigid containers, stacking distribution within the retort shall be equipment shall be designed to ensure documented by heat distribution data that the thickness of the filled contain- or other documentation from a process- ers does not exceed that specified in ing authority, and such data shall be

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maintained on file by the establish- rectly strike the controller bulb or ment and made available to Program probe. employees for review. (ii) Pressure recording device. Each re- (x) Water recirculation. When a water tort shall be equipped with a pressure recirculation system is used for heat recording device which may be com- distribution, the water shall be drawn bined with a pressure controller. from the bottom of the retort through (iii) Steam controllers are required as a suction manifold and discharged described in paragraph (a)(3) of this through a spreader that extends the section. length or circumference of the top of (iv) Heat distribution. Heat distribu- the retort. The holes in the water tion data or other documentation from spreader shall be uniformly distrib- the equipment manufacturer or a proc- uted. The suction outlets shall be pro- essing authority shall be kept on file tected with screens to keep debris from by the establishment and made avail- entering the recirculation system. The able to Program employees for review. pump shall be equipped with a pilot (v) Stacking equipment. All devices light or a similar device to warn the used for holding product containers operator when it is not running, and (e.g., crates, trays, divider plates) shall with a bleeder to remove air when be so constructed to allow the water to starting operations. Alternatively, a circulate around the containers during flow-meter alarm system can be used the come-up and thermal process peri- to ensure proper water circulation. The ods. (vi) Drain valve. A nonclogging, adequacy of water circulation for water-tight drain valve shall be used. maintaining uniform heat distribution Screens shall be installed over all drain within the retort shall be documented openings. by heat distribution data or other doc- (vii) Water level. There shall be a umentation from a processing author- means of determining the water level ity and such data shall be maintained in the retort during operation (i.e., by on file by the establishment and made using a gauge, electronic sensor, or available to Program employees for re- sight glass indicator). Water shall com- view. Alternative methods for recir- pletely cover all containers during the culation of water in the retort may be entire come-up, thermal processing, used, provided there is documentation and cooling periods. A means to ensure in the form of heat distribution data or that water circulation continues as other documentation from a processing specified throughout the come-up, authority maintained on file by the es- thermal processing, and cooling periods tablishment and made available to shall be provided. The retort operator Program employees for review. shall check and record the adequacy of (xi) Cooling water entry. In retorts for the water level with sufficient fre- processing product packed in glass jars, quency to ensure it meets the specified the incoming cooling water should not processing parameters. directly strike the jars, in order to (viii) Air supply and controls. Retorts minimize glass breakage by thermal shall be provided with a means for in- shock. troducing compressed air or steam at (2) Batch agitating retorts. (i) The the pressure required to maintain con- basic requirements and recommenda- tainer integrity. Compressed air and tions for indicating temperature de- steam entry shall be controlled by an vices and temperture/time recording automatic pressure control unit. A devices are described in paragraphs (a) nonreturn valve shall be provided in (1) and (2) of this section. Additionally, the air supply line to prevent water the indicating temperature device bulb from entering the system. Overriding or probe shall extend directly into the air or steam pressure shall be main- water without a separable well or tained continuously during the come- sleeve. The recorder/controller probe up, thermal processing, and cooling pe- shall be located between the water sur- riods. If air is used to promote circula- face and the horizontal plane passing tion, it shall be introduced into the through the center of the retort so that steam line at a point between the re- there is no opportunity for steam to di- tort and the steam control valve at the

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bottom of the retort. The adequacy of available to Program employees for re- the air circulation for maintaining uni- view. Alternative methods for recir- form heat distribution within the re- culation of water in the retort may be tort shall be documented by heat dis- used provided there is documentation tribution data or other documentation in the form of heat distribution data or from a processing authority, and such other documentation from a processing data shall be maintained on file by the authority maintained on file by the es- establishment and made available to tablishment and made available to Program employees for review. Program employees for review. (ix) Retort or reel speed timing. The re- (xi) Cooling water entry. In retorts for tort or reel speed timing shall be processing product packed in glass jars, checked before process timing begins the incoming cooling water should not and, if needed, adjusted as specified in directly strike the jars, in order to the process schedule. In addition, the minimize glass breakage by thermal rotational speed shall be determined shock. and recorded at least once during proc- (d) Pressure processing with steam/air ess timing of each retort load proc- mixtures in batch retorts. (1) The basic essed. Alternatively, a recording ta- requirements for indicating tempera- chometer can be used to provide a con- ture devices and temperature/time re- tinuous record of the speed. The accu- cording devices are described in para- racy of the recording tachometer shall graphs (a) (1) and (2) of this section. be determined and recorded at least Additionally, bulb sheaths or probes once per shift by the establishment by for indicating temperature devices and checking the retort or reel speed using temperature/time recording devices or an accurate stopwatch. A means of pre- controller probes shall be inserted di- venting unauthorized speed changes on rectly into the retort shell in such a retorts shall be provided. For example, position that steam does not strike a lock or a notice from management them directly. posted at or near the speed adjustment (2) Steam controllers are required as device warning that only authorized persons are permitted to make adjust- described in paragraph (a)(3) of this ments are satisfactory means of pre- section. venting unauthorized changes. (3) Recording pressure controller. A re- (x) Water recirculation. If a water recording pressure controller shall be circulation system is used for heat dis- used to control the air inlet and the tribution, it shall be installed in such a steam/air mixture outlet. manner that water will be drawn from (4) Circulation of steam/air mixture. A the bottom of the retort through a suc- means shall be provided for the circulation manifold and discharged through a tion of the steam/air mixture to pre- spreader which extends the length of vent formation of low-temperature the top of the retort. The holes in the pockets. The efficiency of the circula- water spreader shall be uniformly dis- tion system shall be documented by tributed. The suction outlets shall be heat distribution data or other docu- protected with screens to keep debris mentation from a processing authority, from entering the recirculation sys- and such data shall be maintained on tem. The pump shall be equipped with file by the establishment and made a pilot light or a similar device to warn available to Program employees for re- the operator when it is not running and view. The circulation system shall be with a bleeder to remove air when checked to ensure its proper function- starting operations. Alternatively, a ing and shall be equipped with a pilot flow-meter alarm system can be used light or a similar device to warn the to ensure proper water circulation. The operator when it is not functioning. adequacy of water circulation for Because of the variety of existing de- maintaining uniform heat distribution signs, reference shall be made to the within the retort shall be documented equipment manufacturer for details of by heat distribution data or other doc- installation, operation and control. umentation from a processing author- (5) The Administrator shall be noti- ity and such data shall be maintained fied immediately by the official estab- on file by the establishment and made lishment of any such system in use or

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placed into use on or after the effective (5) When water spreaders are used for date of this rule. venting, a maintenance schedule shall (e) Atmospheric cookers—(1) Tempera- be developed and implemented to as- ture/time recording device. Each atmos- sure that the holes are maintained at pheric cooker (e.g., hot water bath) their original size. shall be equipped with at least one (6) Records shall be kept on all main- temperature/time recording device in tenance items that could affect the accordance with the basic require- adequacy of the thermal process. ments described in paragraph (a)(2) of Records shall include the date and type this section. of maintenance performed and the per- (2) Heat distribution. Each atmos- son conducting the maintenance. pheric cooker shall be equipped and op- (h) Container cooling and cooling erated to ensure uniform heat distribu- water. (1) Potable water shall be used tion throughout the processing system for cooling except as provided for in during the thermal process. Heat dis- paragraphs (h) (2) and (3) of this sec- tribution data or other documentation tion. from the manufacturer or a processing (2) Cooling canal water shall be authority demonstrating uniform heat chlorinated or treated with a chemical distribution within the cooker shall be approved by the Administrator as hav- kept on file by the establishment and ing a bactericidal effect equivalent to made available to Program employees chlorination. There shall be a measur- for review. able residual of the sanitizer in the (f) Other systems. All other systems water at the discharge point of the not specifically delineated in this sec- canal. Cooling canals shall be cleaned tion and used for the thermal process- and replenished with potable water to ing of canned product will be evaluated prevent the buildup of organic matter on a case-by-case basis by the and other materials. Adminstrator. Systems will be ap- (3) Container cooling waters that are proved if they are found to conform to recycled or reused shall be handled in the applicable requirements of this sec- systems that are so designed, operated, tion and to produce shelf stable prod- and maintained so there is no buildup ucts consistently and uniformly. of microorganisms, organic matter, (g) Equipment maintenance. (1) Upon and other materials in the systems and installation, all instrumentation and in the waters. System equipment, such controls shall be checked by the estab- as pipelines, holding tanks and cooling lishment for proper functioning and ac- towers, shall be constructed and in- curacy and, thereafter, at any time stalled so that they can be cleaned and their functioning or accuracy is sus- inspected. In addition, the establish- pect. ment shall maintain, and make avail- (2) At least once a year each thermal able to Program employees for review, processing system shall be examined by information on at least the following: an individual not directly involved in (i) System design and construction; daily operations to ensure the proper (ii) System operation including the functioning of the system as well as all rates of renewal with fresh, potable auxiliary equipment and instrumenta- water and the means for treating the tion. In addition, each thermal process- water so that there is a measurable re- ing system should be examined before sidual of an acceptable sanitizer, per the resumption of operation following paragraph (h)(2) of this section, in the an extended shutdown. water at the point where the water (3) Air and water valves that are in- exits the container cooling vessel; tended to be closed during thermal (iii) System maintenance including processing shall be checked by the es- procedures for the periodic cleaning tablishment for leaks. Defective valves and sanitizing of the entire system; shall be repaired or replaced as needed. and (4) Vent and bleeder mufflers shall be (iv) Water quality standards, such as checked and maintained or replaced by microbiological, chemical and phys- the establishment to prevent any re- ical, monitoring procedures including duction in vent or bleeder efficiency. the frequency and site(s) of sampling,

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and the corrective actions taken when time steam on, the time and tempera- water quality standards are not met. ture vent closed, time process tempera- (i) Post-process handling of containers. ture reached, the time the first can en- Containers shall be handled in a man- ters and the time the last can exits the ner that will prevent damage to the retort. The retort or reel speed shall be hermetic seal area. All worn and frayed determined and recorded at intervals belting, can retarders, cushions, and not to exceed 4 hours. Readings of the the like shall be replaced with non- indicating temperature device(s) and porous materials. To minimize con- temperature recorder(s) shall be made tainer abrasions, particularly in the and recorded at the time the first con- seal area, containers should not remain tainer enters the retort and thereafter stationary on moving conveyors. All with sufficient frequency to ensure post-process container handling equip- compliance with the process schedule. ment should be kept clean so there is These observations should be made and no buildup of microorganisms on sur- recorded at intervals not exceeding 30 faces in contact with the containers. minutes of continuous retort oper- (Approved by the Office of Management and ation. Functioning of the condensate Budget under control number 0583–0015) bleeder(s) shall be observed and re- § 381.306 Processing and production corded at the time the first container records. enters the retort and thereafter as At least the following processing and specified in § 381.305(b)(3)(v). production information shall be re- (4) Hydrostatic retorts. Record the recorded by the establishment: Date of tort system number, the approximate production; product name and style; total number of containers retorted, container code; container size and product initial temperature, time type; and the process schedule, includ- steam on, the time and temperature ing the minimum initial temperature. vent(s) closed, time process tempera- Measurements made to satisfy the re- ture reached, time first containers quirements of § 381.303 regarding the enter the retort, time last containers control of critical factors shall be re- exit the retort, and, if specified in the corded. In addition, where applicable, process schedule, measurements of the following information and data temperatures in the hydrostatic water shall also be recorded: legs. Readings of the temperature indi- (a) Processing in steam—(1) Batch still cating device, which is located in the retorts. For each retort batch, record steam/water interface, and the tem- the retort number or other designa- perature recording device shall be ob- tion, the approximate number of con- served and the temperatures recorded tainers or the number of retort crates at the time the first containers enter per retort load, product initial tem- the steam dome. Thereafter, these in- perature, time steam on, the time and struments shall be read and the tem- temperature vent closed, the start of peratures recorded with sufficient fre- process timing, time steam off, and the quency to ensure compliance with the actual processing time. The indicating temperature specified in the process temperature device and the tempera- schedule and should be made at least ture recorder shall be read at the same every hour of continuous retort oper- time at least once during process timing and the observed temperatures re- ation. Container conveyor speed, and corded. for agitating hydrostatic retorts, the (2) Batch agitating retorts. In addition rotative chain speed, shall be deter- to recording the information required mined and recorded at intervals of suf- for batch, still steam retorts in para- ficient frequency to ensure compliance graph (a)(1) of this section, record the with the process schedule and should functioning of the condensate bleed- be performed at least every 4 hours. er(s) and the retort or reel speed. (b) Processing in water—(1) Batch still (3) Continuous rotary retorts. Record retorts. For each retort batch, record the retort system number, the approxi- the retort number or other designa- mate total number of containers re- tion, the approximate number of con- torted, product initial temperature, tainers or number of retort crates per

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retort load, product initial tempera- § 381.307 Record review and mainte- ture, time steam on, the start of proc- nance. ess timing, water level, water recir- (a) Process records. Charts from tem- culation rate (if critical), overriding perature/time recording devices shall pressure maintained, time steam off, be identified by production date, con- and actual processing time. The indi- tainer code, processing vessel number cating temperature device and the or other designation and other data as temperature recorder shall be read at necessary to enable correlation with the same time at least once during the records required in § 381.306. Each process timing and the observed tem- entry on a record shall be made at the peratures recorded. time the specific event occurs, and the (2) Batch agitating retorts. In addition recording individual shall sign or ini- to recording the information required tial each record form. No later than 1 working day after the actual process, in paragraph (b)(1) of this section, the establishment shall review all record the retort or reel speed. processing and production records to (c) Processing in steam/air mixtures. ensure completeness and to determine For each retort batch, record the re- if all product received the process tort number or other designation, the schedule. All records, including the approximate number of containers or temperature/time recorder charts and number of retort crates per retort load, critical factor control records, shall be product initial temperature, time signed or initialed and dated by the steam on, venting procedure, if appli- person conducting the review. All proc- cable, the start of process timing, essing and production records required maintenance of circulation of the in this subpart shall be made available steam/air mixture, air flow rate or to Program employees for review. forced recirculation flow rate (if criti- (b) Automated process monitoring and cal), overriding pressure maintained, recordkeeping. When requested by an es- time steam off, and actual processing tablishment, the Administrator will time. The indicating temperature de- consider the approval of automated vice and the temperature recorder shall process monitoring and recordkeeping systems. An approved system, alone or be read at the same time at least once in combination with written records, during process timing and the observed shall be designed and operated in a temperatures recorded. manner which will ensure compliance (d) Atmospheric cookers—(1) Batch-type with the applicable requirements of systems. For each cooker batch, record § 381.306. the cooker number or other designa- (c) Container closure records. Written tion and the approximate number of records of all container closure exami- containers. In addition, record all criti- nations shall specify the container cal factors of the process schedule such code, the date and time of container as cooker temperature, initial tem- closure examination, the measure- perature, the time the thermal process ment(s) obtained, and any corrective cycle begins and ends, hold time, and actions taken. Records shall be signed the final internal product temperature. or initialed by the container closure (2) Continuous-type systems. Record technician and shall be reviewed and the cooker number or other designa- signed by the establishment within 1 tion, the time the first containers working day after the actual production to ensure that the records are enter and the last containers exit a complete and that the closing oper- cooker, and the approximate total ations have been properly controlled. number of containers processed. In ad- All container closure examination dition, record all critical factors of the records required in this subpart shall process schedule such as the initial be made available to Program employ- temperature, cooker speed, and final ees for review. internal product temperature. (d) Distribution of product. Records (Approved by the Office of Management and shall be maintained by the establish- Budget under control number 0583–0015) ment identifying initial distribution of

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the finished product to facilitate, if (a) A complete description of the de- necessary, the segregation of specific viation along with all necessary sup- production lots that may have been porting documentation; contaminated or are otherwise unsound (b) A copy of the evaluation report; for their intended use. and, (e) Retention of records. Copies of all (c) A description of any product dis- processing and production records re- position actions, either taken or pro- quired in § 381.306 shall be retained for posed. no less than 1 year at the establish- (iv) Product handled in accordance ment, and for an additional 2 years at with paragraph (d)(1)(iii) of this section the establishment or other location from which the records can be made shall not be shipped from the establish- available to Program employees within ment until the Program has reviewed 3 working days. all of the information submitted and approved the product disposition ac- (Approved by the Office of Management and Budget under control number 0583–0015) tions. (v) If an alternate process schedule is § 381.308 Deviations in processing. used that is not on file with the inspec- (a) Whenever the actual process is tor or if an alternate process schedule less than the process schedule or when is immediately calculated and used, any critical factor does not comply the product shall be set aside for fur- with the requirements for that factor ther evaluation in accordance with as specified in the process schedule, it paragraphs (d)(1) (iii) and (iv) of this shall be considered a deviation in proc- section. essing. (vi) When a deviation occurs in a con- (b) Deviations in processing (or proc- tinuous rotary retort, the product shall ess deviations) shall be handled under be handled in accordance with para- an approved quality control program as graphs (d)(1) (iii) and (iv) of this sec- provided in paragraph (c) of this section or in accordance with the follow- tion or shall be handled in accordance ing procedures: with paragraph (d) of this section. (a) Emergency stops. (c) Any partial quality control pro- ( ) When retort jams or breakdowns gram or any portion of a total quality 1 control system for handling process de- occur during the processing operations, viations shall be prepared and submit- all containers shall be given an emer- ted to the Administrator for approval gency still process (developed per in accordance with § 381.145. § 381.302(b)) before the retort is cooled (d) Handling process deviations with- or the retort shall be cooled promptly out an approved quality control pro- and all containers removed and either gram. reprocessed, repacked and reprocessed, (1) Deviations identified in-process. If a or destroyed. Regardless of the proce- deviation is noted at any time before dure used, containers in the retort in- the completion of the intended process take valve and in transfer valves be- schedule, the establishment shall: tween retort shells at the time of a jam (i) Immediately reprocess the prod- or breakdown shall be removed and ei- uct using the full process schedule; or, ther reprocessed, repacked and reproc- (ii) Use an appropriate alternate essed, or destroyed. Product to be de- process schedule provided such a proc- stroyed shall be handled as ‘‘U.S. In- ess schedule has been established in ac- spected and Condemned’’, as defined in cordance with § 381.302 (a) and (b) and is § 301.2(ee) of this chapter, and disposed filed with the inspector in accordance of in accordance with part 314 of this with § 381.302(c); or, chapter. (iii) Hold the product involved and have the deviation evaluated by a proc- (2) The time the retort reel stopped essing authority to assess the safety and the time the retort is used for an and stability of the product. Upon com- emergency still retort process shall be pletion of the evaluation, the establish- noted on the temperature/time record- ment shall provide the inspector the ing device and entered on the other following: production records required in § 381.306.

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(b) Temperature drops. When the reproduction records, a full description of tort temperature drops below the tem- the corrective actions taken, the eval- perature specified in the process sched- uation procedures and results, and the ule, the reel shall be stopped and the disposition of the affected product. following actions shall be taken: Such records shall be maintained in a (1) For temperature drops of less separate file or in a log that contains than 10 °F (or 5.5 °C) either (i) all con- the appropriate information. The file tainers in the retort shall be given an or log shall be retained in accordance emergency still process (developed per with § 381.307(e) and shall be made § 381.302(b)) before the reel is restarted; available to Program employees upon (ii) container entry to the retort shall request. be prevented and an emergency agitat- (Approved by the Office of Management and ing process (developed per § 381.302(b)) Budget under control number 0583–0015) shall be used before container entry to the retort is restarted; or (iii) container § 381.309 Finished product inspection. entry to the retort shall be prevented (a) Finished product inspections shall and the reel restarted to empty the re- be handled under an approved quality tort. The discharged containers shall control program as provided in para- be reprocessed, repacked and reproc- graph (b) or paragraph (c) of this sec- essed, or destroyed. Product to be de- tion or shall be handled in accordance stroyed shall be handled as ‘‘U.S. In- with paragraph (d) of this section. spected and Condemned’’, as defined in (b) Any partial quality control pro- § 301.2(ee) of this chapter, and disposed gram for finished product inspection of in accordance with part 314 of this shall be prepared and submitted to the chapter. Administrator for approval in accord- (2) For temperature drops of 10 °F (or ance with § 381.145 of this part. 5.5 °C) or more, all containers in the re- (c) That portion of a total quality tort shall be given an emergency still control system for finished product in- process (developed per § 381.302(b)). The spection shall be prepared and submit- time the reel was stopped and the time ted to the Administrator for approval the retort was used for a still retort in accordance with § 381.145 of this part. process shall be marked on the tem- (d) Handling finished product inspec- perature/time recording device by the tions without an approved quality con- establishment and entered on the other trol program. production records required in § 381.306. (1) Incubation of shelf stable canned Alternatively, container entry to the product—(i) Incubator. The establish- retort shall be prevented and the reel ment shall provide incubation facilities restarted to empty the retort. The dis- which include an accurate tempera- charged containers shall be either re- ture/time recording device, an indicat- processed, repacked and reprocessed, or ing temperature device, a means for destroyed. Product to be destroyed the circulation of the air inside the in- shall be handled as ‘‘U.S. Inspected and cubator to prevent temperature vari- Condemned’’ as defined in § 301.2(ee) of ations, and a means to prevent unau- this chapter, and disposed of in accord- thorized entry into the facility. The ance with part 314 of this chapter. Program is responsible for the security (2) Deviations identified through record of the incubator. review. Whenever a deviation is noted (ii) Incubation temperature. The incu- during review of the processing and bation temperature shall be main- production records required by § 381.307 tained at 95±5 °F (35±2.8 °C). If the incu- (a) and (b), the establishment shall bation temperature falls below 90 °F (or hold the product involved and the devi- 32 °C) or exceeds 100 °F (or 38 °C) but ation shall be handled in accordance does not reach 103 °F (or 39.5 °C), the with paragraphs (d)(1) (iii) and (iv) of incubation temperature shall be ad- this section. justed within the required range and (e) Process deviation file. The estab- the incubation time extended for the lishment shall maintain full records re- time the sample containers were held garding the handling of each deviation. at the deviant temperature. If the incu- Such records shall include, at a mini- bation temperature is at or above 103 mum, the appropriate processing and °F (or 39.5 °C) for more than 2 hours,

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the incubation test(s) shall be termi- ship product prior to the completion of nated, the temperature lowered to the required incubation period shall within the required range, and new submit a written proposal to the area sample containers incubated for the re- supervisor. Such a proposal shall in- quired time. clude provisions that will assure that (iii) Product requiring incubation. shipped product will not reach the re- Shelf stable product requiring incuba- tail level of distribution before sample tion includes: incubation is completed and that prod- (a) Low acid products as defined in uct can be returned promptly to the es- § 381.300(m); and tablishment should such action be (b) Acidified low acid products as de- deemed necessary by the incubation fined in § 381.300(b). test results. Upon receipt of written (iv) Incubation samples. (a) From each approval from the area supervisor, load of product processed in a batch- product may be routinely shipped pro- type thermal processing system (still vided the establishment continues to or agitation), the establishment shall comply with all requirements of this select at least one container for incu- subpart. bation. (2) Container condition. (i) Normal con- (b) For continuous rotary retorts, hy- tainers. Only normal-appearing con- drostatic retorts, or other continuous- tainers shall be shipped from an estab- type thermal processing systems, the lishment as determined by an appro- establishment shall select at least one priate sampling plan or other means container per 1,000 for incubation. acceptable to Program employees. (c) Only normal-appearing containers (ii) Abnormal containers. When abnor- shall be selected for incubation. mal containers are detected by any (v) Incubation time. Canned product means other than incubation, the es- requiring incubation shall be incubated tablishment shall inform the inspector for not less than 10 days (240 hours) and the affected code lot(s) shall not be under the conditions specified in para- shipped until the Program has deter- graph (d)(1)(ii) of this section. mined that the product is safe and sta- (vi) Incubation checks and record main- ble. Such a determination will take tenance. Designated establishment em- into account the cause and level of ployees shall visually check all con- abnormals in the affected lot(s) as well tainers under incubation each working as any product disposition actions ei- day and the inspector shall be notified ther taken or proposed by the estab- when abnormal containers are de- lishment. tected. All abnormal containers should (Approved by the Office of Management and be allowed to cool before a final deci- Budget under control number 0583–0015) sion on their condition is made. For [51 FR 45634, Dec. 19, 1986, as amended at 57 each incubation test the establishment FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, shall record at least the product name, 1992] container size, container code, number of containers incubated, in and out § 381.310 Personnel and training. dates, and incubation results. The es- All operators of thermal processing tablishment shall retain such records, systems specified in § 381.305 and con- along with copies of the temperature/ tainer closure technicians shall be time recording charts, in accordance under the direct supervision of a person with § 381.307(e). who has successfully completed a (vii) Abnormal containers. The finding school of instruction that is generally of abnormal containers (as defined in recognized as adequate for properly § 381.300(a)) among incubation samples training supervisors of canning oper- is cause to officially retain at least the ations. code lot involved. (viii) Shipping. No product shall be [51 FR 45634, Dec. 19, 1986] shipped from the establishment before the end of the required incubation pe- § 381.311 Recall procedure. riod except as provided in this para- Establishments shall prepare and graph or paragraph (b) or (c) of this maintain a current procedure for the section. An establishment wishing to recall of all canned product covered by

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this subpart. Upon request, the recall ciency of available space for the nutri- procedure shall be made available to tion information, the space needed for Program employees for review. vignettes, designs, and other non- (Approved by the Office of Management and mandatory label information on the Budget under control number 0583–0015) principal display panel may be considered. Subpart Y—Nutrition Labeling [58 FR 675, Jan. 6, 1993, as amended at 59 FR 40215, Aug. 8, 1994] SOURCE: 58 FR 675, Jan. 6, 1993, unless otherwise noted. §§ 381.403–381.407 [Reserved]

§ 381.400 Nutrition labeling of poultry § 381.408 Labeling of poultry products products. with number of servings. (a) Nutrition labeling shall be pro- The label of any package of a poultry vided for all poultry products intended product that bears a representation as for human consumption and offered for to the number of servings contained in sale, except single-ingredient, raw such package shall meet the require- products, in accordance with the re- ments of § 381.121(c)(7). quirements of § 381.409, except as exempted under § 381.500 of this subpart. § 381.409 Nutrition label content. (b) Nutrition labeling may be provided for single-ingredient, raw poultry (a) All nutrient and food component products in accordance with the re- quantities shall be declared in relation quirements of §§ 381.409 and 381.445. Sig- to a serving as defined in this section. nificant participation in voluntary nu- (b)(1) The term ‘‘serving’’ or ‘‘serving trition labeling shall be measured by size’’ means an amount of food cus- the Agency in accordance with tomarily consumed per eating occasion §§ 381.443 and 381.444 of this subpart. by persons 4 years of age or older, which is expressed in a common house- [58 FR 675, Jan. 6, 1993, as amended at 60 FR hold measure that is appropriate to the 197, Jan. 3, 1995] product. When the product is specially § 381.401 [Reserved] formulated or processed for use by infants or by toddlers, a serving or serv- § 381.402 Location of nutrition infor- ing size means an amount of food cus- mation. tomarily consumed per eating occasion (a) Nutrition information on a label by infants up to 12 months of age or by of a packaged poultry product shall ap- children 1 through 3 years of age, re- pear on the label’s principal display spectively. panel or on the information panel, ex- (2) Except as provided in paragraphs cept as provided in paragraphs (b) and (b)(8), (b)(12), and (b)(14) of this section (c) of this section. and for products that are intended for (b) Nutrition information for gift weight control and are available only packs may be shown at a location through a weight-control or weight- other than on the product label, pro- maintenance program, the serving size vided that the labels for these products declared on a product label shall be de- bear no nutrition claim. In lieu of on termined from the ‘‘Reference the product label, nutrition informa- Amounts Customarily Consumed Per tion may be provided by alternate Eating Occasion—General Food Sup- means such as product label inserts. ply’’ (Reference Amount(s)) that ap- (c) Poultry products in packages that pear in § 381.412(b) using the procedures have a total surface area available to described in this paragraph (b). For bear labeling greater than 40 square products that are both intended for inches but whose principal display weight control and available only panel and information panel do not through a weight-control program, a provide sufficient space to accommo- manufacturer may determine the serv- date all required information may use ing size that is consistent with the any alternate panel that can be readily meal plan of the program. Such prod- seen by consumers for the nutrition in- ucts must bear a statement, ‘‘for sale formation. In determining the suffi- only through the lll program’’ (fill

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in the blank with the name of the ap- multi-serving package, if a unit con- propriate weight-control program, e.g., tains more than 150 percent but less Smith’s Weight Control), on the prin- than 200 percent of the Reference cipal display panel. However, the Ref- Amount, the manufacturer may decide erence Amounts in § 381.412(b) shall be whether to declare the individual unit used for purposes of evaluating wheth- as 1 or 2 servings. er weight-control products that are (vi) For products which consist of available only through a weight-con- two or more foods packaged and pre- trol program qualify for nutrition sented to be consumed together where claims. the ingredient represented as the main (3) The declaration of nutrient and ingredient is in discrete units (e.g., food component content shall be on the chicken wings and barbecue sauce), the basis of the product ‘‘as packaged’’ for serving size may be the number of dis- all products, except that single-ingre- crete units represented as the main in- dient, raw products may be declared on gredient plus proportioned minor in- the basis of the product ‘‘as consumed’’ gredients used to make the Reference as set forth in § 381.445(a)(1). In addition Amount for the combined product as to the required declaration on the basis determined in § 381.412(c). of ‘‘as packaged’’ for products other (vii) For packages containing several than single ingredient, raw products, individual single-serving containers, the declaration may also be made on each of which is labeled with all re- the basis of ‘‘as consumed,’’ provided quired information including nutrition that preparation and cooking instruc- labeling as specified in this section tions are clearly stated. (i.e., are labeled appropriately for indi- (4) For products in discrete units (e.g., chicken wings, and individually vidual sale as single-serving contain- packaged products within a multi-serv- ers), the serving size shall be 1 unit. ing package), and for products which (5) For products in large discrete consist of two or more foods packaged units that are usually divided for con- and presented to be consumed together sumption (e.g., pizza, pan of poultry where the ingredient represented as the lasagna), for unprepared products main ingredient is in discrete units where the entire contents of the pack- (e.g., chicken wings and barbecue age is used to prepare large discrete sauce), the serving size shall be de- units that are usually divided for con- clared as follows: sumption (e.g., pizza kit), and for prod- (i) If a unit weighs 50 percent or less ucts which consist of two or more foods of the Reference Amount, the serving packaged and presented to be size shall be the number of whole units consumed together where the ingredi- that most closely approximates the ent represented as the main ingredient Reference Amount for the product cat- is a large discrete unit usually divided egory. for consumption, the serving size shall (ii) If a unit weighs more than 50 per- be the fractional slice of the ready-to- cent but less than 67 percent of the eat product (e.g., 1⁄8 quiche, 1⁄4 pizza) Reference Amount, the manufacturer that most closely approximates the may declare one unit or two units as Reference Amount for the product cat- the serving size. egory. The serving size may be the (iii) If a unit weighs 67 percent or fraction of the package used to make more but less than 200 percent of the the Reference Amount for the unpre- Reference Amount, the serving size pared product determined in § 381.412(d) shall be one unit. or the fraction of the large discrete (iv) If a unit weighs 200 percent or unit represented as the main ingredi- more of the Reference Amount, the ent plus proportioned minor ingredi- manufacturer may declare one unit as ents used to make the Reference the serving size if the whole unit can Amount of the combined product deter- reasonably be consumed at a single mined in § 381.412(c). In expressing the eating occasion. fractional slice, manufacturers shall (v) For products that have Reference use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions Amounts of 100 grams (or milliliter) or that can be generated by further divi- larger and are individual units within a sion by 2 or 3.

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(6) For nondiscrete bulk products single-serving containers and meal- (e.g., whole turkey, turkey breast, type products and for individually ground poultry), and for products packaged products within multi-serv- which consist of two or more foods ing containers (e.g., can, box, package, packaged and presented to be meal, or dinner). A description of the consumed together where the ingredi- individual unit shall be used for other ent represented as the main ingredient products in discrete units (e.g., wing, is a bulk product (e.g., turkey breast slice, link, or patty). and gravy), the serving size shall be the (v) For unprepared products where amount in household measure that the entire contents of the package is most closely approximates the Ref- used to prepare large discrete units erence Amount for the product cat- that are usually divided for consump- egory and may be the amount of the tion (e.g., pizza kit), the fraction or bulk product represented as the main portion of the package may be used. ingredient plus proportioned minor in- (vi) For products that consist of two gredients used to make the Reference or more distinct ingredients or compo- Amount for the combined product de- nents packaged and presented to be termined in § 381.412(c). consumed together (e.g., chicken wings (7) For labeling purposes, the term with a glaze packet), the nutrition in- ‘‘common household measure’’ or formation may be declared for each ‘‘common household unit’’ means cup, component or as a composite. The serv- tablespoon, teaspoon, piece, slice, frac- ing size may be provided in accordance tion (e.g., 1⁄4 pizza), ounce (oz), or other with the provisions of paragraphs common household equipment used to (b)(4), (b)(5), and (b)(6) of this section. package food products (e.g., jar or (vii) For nutrition labeling purposes, tray). In expressing serving size in a teaspoon means 5 milliliters (mL), a household measures, except as speci- tablespoon means 15 mL, a cup means fied in paragraphs (b)(7)(iv), (v), and 240 mL, and 1 oz in weight means 28 (vi) of this section, the following rules grams (g). shall be used: (viii) When a serving size, determined (i) Cups, tablespoons, or teaspoons from the Reference Amount in shall be used wherever possible and ap- § 381.412(b) and the procedures described propriate. Cups shall be expressed in 1⁄4- in this section, falls exactly half way or 1⁄3-cup increments, tablespoons in between two serving sizes (e.g., 2.5 whole number of tablespoons for quan- tbsp), manufacturers shall round the tities less than 1⁄4 cup but greater than serving size up to the next incremental or equal to 2 tablespoons (tbsp), 1, 11⁄3, size. 11⁄2, or 12⁄3 tbsp for quantities less than (8) A product that is packaged and 2 tbsp but greater than or equal to 1 sold individually and that contains less tbsp, and teaspoons in whole number of than 200 percent of the applicable Ref- teaspoons for quantities less than 1 erence Amount shall be considered to tbsp but greater than or equal to 1 tea- be a single-serving container, and the spoon (tsp), and in 1⁄4-tsp increments entire content of the product shall be for quantities less than 1 tsp. labeled as one serving, except for prod- (ii) If cups, tablespoons or teaspoons ucts that have Reference Amounts of are not applicable, units such as piece, 100 g (or mL) or larger, manufacturers slice, tray, jar, and fraction shall be may decide whether a package that used. contains more than 150 percent but less (iii) If cups, tablespoons and than 200 percent of the Reference teaspoons, or units such as piece, slice, Amount is 1 or 2 servings. Packages tray, jar, or fraction are not applicable, sold individually that contain 200 per- ounces may be used. Ounce measure- cent or more of the applicable Ref- ments shall be expressed in 0.5-ounce erence Amount may be labeled as a sin- increments most closely approximat- gle-serving if the entire content of the ing the Reference Amount with round- package can reasonably be consumed ing indicated by the use of the term at a single-eating occasion. ‘‘about’’ (e.g., about 2.5 ounces). (9) A label statement regarding a (iv) A description of the individual serving shall be the serving size ex- container or package shall be used for pressed in common household measures

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as set forth in paragraphs (b)(2) be rounded to the nearest 0.5 serving. through (b)(8) of this section and shall Rounding should be indicated by the be followed by the equivalent metric use of the term ‘‘about’’ (e.g., about 2 quantity in parenthesis (fluids in milli- servings; about 3.5 servings). liters and all other foods in grams), ex- (ii) When the serving size is required cept for single-serving containers. to be expressed on a drained solids (i) For a single-serving container, the basis and the number of servings varies parenthetical metric quantity, which because of a natural variation in unit will be presented as part of the net size, the manufacturer may state the weight statement on the principal dis- typical number of servings per con- play panel, is not required except tainer (e.g., usually 5 servings). where nutrition information is re- (iii) For random weight products, a quired on a drained weight basis ac- manufacturer may declare ‘‘varied’’ for cording to paragraph (b)(11) of this sec- the number of servings per container tion. However, if a manufacturer vol- provided the nutrition information is untarily provides the metric quantity based on the Reference Amount ex- on products that can be sold as single pressed in ounces. The manufacturer servings, then the numerical value pro- may provide the typical number of vided as part of the serving size dec- servings in parenthesis following the laration must be identical to the met- ‘‘varied’’ statement (e.g., varied (ap- ric quantity declaration provided as proximately 8 servings per pound)). part of the net quantity of contents (iv) For packages containing several statement. individual single-serving containers, (ii) The gram or milliliter quantity each of which is labeled with all re- equivalent to the household measure quired information including nutrition should be rounded to the nearest whole labeling as specified in this section number except for quantities that are (i.e., are labeled appropriately for indi- less than 5 g (mL). The gram (mL) vidual sale as single-serving contain- quantity between 2 and 5 g (mL) should ers), the number of servings shall be be rounded to the nearest 0.5 g (mL) and the g (mL) quantity less than 2 g the number of individual packages (mL) should be expressed in 0.1-g (mL) within the total package. increments. (v) For packages containing several (iii) In addition, serving size may be individually packaged multi-serving declared in ounce, in parenthesis, fol- units, the number of servings shall be lowing the metric measure separated determined by multiplying the number by a slash where other common house- of individual multi-serving units in the hold measures are used as the primary total package by the number of unit for serving size, e.g., 1 slice (28 g/ servings in each individual unit. 1 oz) for sliced chicken roll. The ounce (11) The declaration of nutrient and quantity equivalent to the metric food component content shall be on the quantity should be expressed in 0.1-oz basis of product as packaged or pur- increments. chased with the exception of products (iv) If a manufacturer elects to use that are packed or canned in water, abbreviations for units, the following brine, or oil but whose liquid packing abbreviations shall be used: tbsp for ta- medium is not customarily consumed. blespoon, tsp for teaspoon, g for gram, Declaration of the nutrient and food mL for milliliter, and oz for ounce. component content of products that (10) Determination of the number of are packed in liquid which is not cus- servings per container shall be based tomarily consumed shall be based on on the serving size of the product de- the drained solids. termined by following the procedures (12) Serving size for meal-type prod- described in this section. ucts as defined in § 381.413(l) shall be (i) The number of servings shall be the entire content (edible portion only) rounded to the nearest whole number of the package. except for the number of servings be- (13) Another column of figures may tween 2 and 5 servings and random be used to declare the nutrient and weight products. The number of food component information in the servings between 2 and 5 servings shall same format as required by § 381.409(e),

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(i) Per 100 grams, 100 milliliters, or 1 calories may be expressed as zero. En- ounce of the product as packaged or ergy content per serving may also be purchased. expressed in kilojoule units, added in (ii) Per one unit if the serving size of parenthesis immediately following the a product in discrete units in a multi- statement of the caloric content. serving container is more than one (i) Caloric content may be calculated unit. by the following methods. Where either (14) If a product consists of assort- specific or general food factors are ments of poultry products (e.g., variety used, the factors shall be applied to the packs) in the same package, nutrient actual amount (i.e., before rounding) of content shall be expressed on the en- food components (e.g., fat, carbo- tire package contents or on each indi- hydrate, protein, or ingredients with vidual product. specific food factors) present per serv- (15) If a product is commonly coming. bined with other ingredients or is (A) Using specific Atwater factors cooked or otherwise prepared before (i.e., the Atwater method) given in eating, and directions for such com- Table 13, page 25, ‘‘Energy Value of bination or preparations are provided, Foods—Basis and Derivation,’’ by A. L. another column of figures may be used Merrill and B. K. Watt, United States to declare the nutrient contents on the Department of Agriculture (USDA), basis of the product as consumed for Agriculture Handbook No. 74 (Slightly the product alone (e.g., a cream soup revised February 1973), which is incor- mix may be labeled with one set of porated by reference. Table 13 of the Daily Values for the dry mix (per serv- ‘‘Energy Value of Foods—Basis and ing), and another set for the serving of Derivation,’’ Agriculture Handbook No. the final soup when prepared (e.g., per 74 is incorporated as it exists on the serving of cream soup mix and 1 cup of date of approval. This incorporation by vitamin D fortified whole milk)): Pro- reference was approved by the Director vided, that the type and quantity of the of the Federal Register in accordance other ingredients to be added to the with 5 U.S.C. 552(a) and 1 CFR part 51. product by the user and the specific It is available for inspection at the Of- method of cooking and other prepara- fice of the Federal Register, suite 700, tion shall be specified prominently on 800 North Capitol Street, NW., Wash- the label. ington, DC, or at the office of the FSIS (c) The declaration of nutrition infor- Docket Clerk, Room 3171, South Build- mation on the label or in labeling of a ing, 14th and Independence Avenue, poultry product shall contain informa- SW., Washington, DC. Copies of the in- tion about the level of the following corporation by reference are available nutrients, except for those nutrients from the Product Assessment Division, whose inclusion, and the declaration of Regulatory Programs, Food Safety and amounts, is voluntary as set forth in Inspection Service, U.S. Department of this paragraph. No nutrients or food Agriculture, Room 329, West End Court components other than those listed in Building, Washington, DC 20250–3700; this paragraph as either mandatory or (B) Using the general factors of 4, 4, voluntary may be included within the and 9 calories per gram for protein, nutrition label. Except as provided for total carbohydrate, and total fat, rein paragraph (f) or (g) of this section, spectively, as described in USDA’s Ag- nutrient information shall be presented riculture Handbook No. 74 (Slightly re- using the nutrient names specified and vised February 1973), pages 9–11, which in the following order in the formats is incorporated by reference. Pages 9– specified in paragraph (d) or (e) of this 11, Agriculture Handbook No. 74 is in- section. corporated as it exists on the date of (1) ‘‘Calories, total,’’ ‘‘Total cal- approval. This incorporation by ref- ories,’’ or ‘‘Calories’’: A statement of erence was approved by the Director of the caloric content per serving, ex- the Federal Register in accordance pressed to the nearest 5-calorie incre- with 5 U.S.C. 552(a) and 1 CFR part 51. ment up to and including 50 calories, (The availability of this incorporation and 10-calorie increment above 50 cal- by reference is given in paragraph ories, except that amounts less than 5 (c)(1)(i)(A) of this section.);

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(C) Using the general factors of 4, 4, (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A and 9 calories per gram for protein, statement of the number of grams of total carbohydrate less the amount of saturated fat per serving defined as the insoluble dietary fiber, and total fat, sum of all fatty acids containing no respectively, as described in USDA’s double bonds, except that label dec- Agriculture Handbook No. 74 (Slightly laration of saturated fat content infor- revised February 1973), pages 9–11, mation is not required for products which is incorporated by reference in that contain less than 0.5 gram of total accordance with 5 U.S.C. 552(a) and 1 fat per serving if no claims are made CFR part 51. (The availability of this about fat or cholesterol content, and if incorporation by reference is given in ‘‘calories from saturated fat’’ is not de- paragraph (c)(1)(i)(A) of this section.); clared. Saturated fat content shall be or indented and expressed as grams per (D) Using data for specific food fac- serving to the nearest 0.5 (1⁄2)-gram in- tors for particular foods or ingredients crement below 5 grams and to the near- approved by the Food and Drug Admin- est gram increment above 5 grams. If istration (FDA) and provided in parts the serving contains less than 0.5 gram, 172 or 184 of 21 CFR, or by other means, the content shall be expressed as zero. as appropriate. (A) ‘‘Stearic Acid’’ (VOLUNTARY): A (ii) ‘‘Calories from fat’’: A statement statement of the number of grams of of the caloric content derived from stearic acid per serving may be de- total fat as defined in paragraph (c)(2) clared voluntarily, except that when a of this section per serving, expressed to claim is made about stearic acid, label the nearest 5-calorie increment, up to declaration shall be required. Stearic and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this section. (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- (iii) ‘‘Calories from saturated fat’’ or unsaturated’’ (VOLUNTARY): A state- ‘‘Calories from saturated’’ (VOL- ment of the number of grams of poly- UNTARY): A statement of the caloric unsaturated fat per serving defined as content derived from saturated fat as cis,cis-methylene-interrupted poly- defined in paragraph (c)(2)(i) of this unsaturated fatty acids may be de- section per serving may be declared clared voluntarily, except that when voluntarily, expressed to the nearest 5- monounsaturated fat is declared, or calorie increment, up to and including when a claim about fatty acids or cho- 50 calories, and the nearest 10-calorie lesterol is made on the label or in la- increment above 50 calories, except beling of a product other than one that that amounts less than 5 calories may meets the criteria in § 381.462(b)(1) for a be expressed as zero. This statement claim for ‘‘fat free,’’ label declaration shall be indented under the statement of polyunsaturated fat is required. of calories from fat as provided in para- Polyunsaturated fat content shall be graph (d)(5) of this section. indented and expressed as grams per (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A serving to the nearest 0.5 (1⁄2)-gram in- statement of the number of grams of crement below 5 grams and to the near- total fat per serving defined as total est gram increment above 5 grams. If lipid fatty acids and expressed as the serving contains less than 0.5 gram, triglycerides. Amounts shall be ex- the content shall be expressed as zero. pressed to the nearest 0.5 (1⁄2)-gram in- (iii) ‘‘Monounsaturated fat’’ or crement below 5 grams and to the near- ‘‘Monounsaturated’’ (VOLUNTARY): A est gram increment above 5 grams. If statement of the number of grams of the serving contains less than 0.5 gram, monounsaturated fat per serving de- the content shall be expressed as zero. fined as cis-monounsaturated fatty

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acids may be declared voluntarily, ex- per serving expressed to the nearest cept that when polyunsaturated fat is gram, except that if a serving contains declared, or when a claim about fatty less than 1 gram, the statement ‘‘Con- acids or cholesterol is made on the tains less than 1 gram’’ or ‘‘less than 1 label or in labeling of a product other gram’’ may be used as an alternative, than one that meets the criteria in or, if the serving contains less than 0.5 § 381.462(b)(1) for a claim for ‘‘fat free,’’ gram, the content may be expressed as label declaration of monounsaturated zero. Total carbohydrate content shall fat is required. Monounsaturated fat be calculated by subtraction of the sum content shall be indented and expressed of the crude protein, total fat, mois- as grams per serving to the nearest 0.5 ture, and ash from the total weight of 1 ( ⁄2)-gram increment below 5 grams and the product. This calculation method is to the nearest gram increment above 5 described in USDA’s Agriculture Hand- grams. If the serving contains less than book No. 74 (Slightly revised February 0.5 gram, the content shall be expressed 1973), pages 2 and 3, which is incor- as zero. porated by reference. Pages 2 and 3, Ag- (3) ‘‘Cholesterol’’: A statement of the riculture Handbook No. 74 is incor- cholesterol content per serving expressed in milligrams to the nearest 5- porated as it exists on the date of ap- milligram increment, except that label proval. This incorporation by reference declaration of cholesterol information was approved by the Director of the is not required for products that con- Federal Register in accordance with 5 tain less than 2 milligrams of choles- U.S.C. 552(a) and 1 CFR part 51. (The terol per serving and make no claim availability of this incorporation by about fat, fatty acids, or cholesterol reference is given in paragraph content, or such products may state (c)(1)(i)(A) of this section.). the cholesterol content as zero. If the (i) ‘‘Dietary fiber’’: A statement of product contains 2 to 5 milligrams of the number of grams of total dietary cholesterol per serving, the content fiber per serving, indented and ex- may be stated as ‘‘less than 5 milli- pressed to the nearest gram, except grams.’’ that if a serving contains less than 1 (4) ‘‘Sodium’’: A statement of the gram, declaration of dietary fiber is number of milligrams of sodium per not required, or, alternatively, the serving expressed as zero when the statement ‘‘Contains less than 1 gram’’ serving contains less than 5 milligrams or ‘‘less than 1 gram’’ may be used, and of sodium, to the nearest 5-milligram if the serving contains less than 0.5 increment when the serving contains 5 gram, the content may be expressed as to 140 milligrams of sodium, and to the zero. nearest 10-milligram increment when (A) ‘‘Soluble fiber’’ (VOLUNTARY): the serving contains greater than 140 A statement of the number of grams of milligrams. soluble dietary fiber per serving may (5) ‘‘Potassium’’ (VOLUNTARY): A be declared voluntarily except when a statement of the number of milligrams claim is made on the label or in label- of potassium per serving may be de- ing about soluble fiber, label declara- clared voluntarily, except that when a tion shall be required. Soluble fiber claim is made about potassium content, label declaration shall be re- content shall be indented under dietary quired. Potassium content shall be ex- fiber and expressed to the nearest pressed as zero when the serving con- gram, except that if a serving contains tains less than 5 milligrams of potas- less than 1 gram, the statement ‘‘Con- sium, to the nearest 5-milligram incre- tains less than 1 gram’’ or ‘‘less than 1 ment when the serving contains 5 to gram’’ may be used as an alternative, 140 milligrams of potassium, and to the and if the serving contains less than 0.5 nearest 10-milligram increment when gram, the content may be expressed as the serving contains greater than 140 zero. milligrams. (B) ‘‘Insoluble fiber’’ (VOLUNTARY): (6) ‘‘Carbohydrate, total’’ or ‘‘Total A statement of the number of grams of carbohydrate’’: A statement of the insoluble dietary fiber per serving may number of grams of total carbohydrate be declared voluntarily except when a

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claim is made on the label or in label- less than 0.5 gram, the content may be ing about insoluble fiber, label declara- expressed as zero. tion shall be required. Insoluble fiber (iv) ‘‘Other carbohydrate’’ (VOL- content shall be indented under dietary UNTARY): A statement of the number fiber and expressed to the nearest of grams of other carbohydrate per gram, except that if a serving contains serving may be declared voluntarily. less than 1 gram, the statement ‘‘Con- Other carbohydrate shall be defined as tains less than 1 gram’’ or ‘‘less than 1 the difference between total carbo- gram’’ may be used as an alternative, hydrate and the sum of dietary fiber, and if the serving contains less than 0.5 sugars, and sugar alcohol, except that gram, the content may be expressed as if sugar alcohol is not declared (even if zero. present), it shall be defined as the dif- (ii) ‘‘Sugars’’: A statement of the ference between total carbohydrate and number of grams of sugars per serving, the sum of dietary fiber and sugars. except that label declaration of sugars Other carbohydrate content shall be in- content is not required for products dented and expressed to the nearest that contain less than 1 gram of sugars gram, except that if a serving contains per serving if no claims are made about less than 1 gram, the statement ‘‘Con- sweeteners, sugars, or sugar alcohol tains less than 1 gram’’ or ‘‘less than 1 content. Sugars shall be defined as the gram’’ may be used as an alternative, sum of all free mono- and disaccharides and if the serving contains less than 0.5 (such as glucose, fructose, lactose, and gram, the content may be expressed as sucrose). Sugars content shall be in- zero. dented and expressed to the nearest (7) ‘‘Protein’’: A statement of the gram, except that if a serving contains number of grams of protein per serving less than 1 gram, the statement ‘‘Con- expressed to the nearest gram, except tains less than 1 gram’’ or ‘‘less than 1 that if a serving contains less than 1 gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4 as the sum of saccharide derivatives in years of age has a protein quality value which a hydroxyl group replaces a ke- that is a protein digestibility-corrected tone or aldehyde group and whose use amino acid score of less than 40 ex- in the food is listed by FDA (e.g., pressed as a percent, either of the fol- mannitol or xylitol) or is generally rec- lowing shall be placed adjacent to the ognized as safe (e.g., sorbitol). In lieu declaration of protein content by of the term ‘‘sugar alcohol,’’ the name weight: The statement ‘‘not a signifi- of the specific sugar alcohol (e.g., cant source of protein,’’ or a listing ‘‘xylitol’’) present in the product may aligned under the column headed ‘‘Per- be used in the nutrition label, provided cent Daily Value’’ of the corrected that only one sugar alcohol is present amount of protein per serving, as de- in the product. Sugar alcohol content termined in paragraph (c)(7)(ii) of this shall be indented and expressed to the section, calculated as a percentage of nearest gram, except that if a serving the Daily Reference Value (DRV) or contains less than 1 gram, the state- Reference Daily Intake (RDI), as appro- ment ‘‘Contains less than 1 gram’’ or priate, for protein and expressed as per- ‘‘less than 1 gram’’ may be used as an cent of Daily Value. When the protein alternative, and if the serving contains quality in a product as measured by

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the Protein Efficiency Ratio (PER) is tion of the United Nations/World less than 40 percent of the reference Health Organization, is incorporated as standard (casein) for a product rep- it exists on the date of approval. This resented or purported to be for infants, incorporation by reference was ap- the statement ‘‘not a significant source proved by the Director of the Federal of protein’’ shall be placed adjacent to Register in accordance with 5 U.S.C. the declaration of protein content. Pro- 552(a) and 1 CFR part 51. It is available tein content may be calculated on the for inspection at the Office of the Fed- basis of the factor of 6.25 times the ni- eral Register, suite 700, 800 North Cap- trogen content of the food as deter- itol Street, NW., Washington, DC, or at mined by appropriate methods of anal- the office of the FSIS Docket Clerk, ysis in accordance with § 381.409(h), ex- Room 3171, South Building, 14th and cept when the procedure for a specific Independence Avenue, SW., Washing- food requires another factor. ton, DC. Copies of the incorporation by (i) A statement of the corrected reference are available from the Prod- amount of protein per serving, as de- uct Assessment Division, Regulatory termined in paragraph (c)(7)(ii) of this Programs, Food Safety and Inspection section, calculated as a percentage of Service, U.S. Department of Agri- the RDI or DRV for protein, as appro- culture, Room 329, West End Court priate, and expressed as percent of Building, Washington, DC 20250–3700. Daily Value, may be placed on the For products represented or purported label, except that such a statement to be for infants, the corrected amount shall be given if a protein claim is of protein (grams) per serving is equal made for the product, or if the product to the actual amount of protein is represented or purported to be for in- (grams) per serving multiplied by the fants or children under 4 years of age. relative protein quality value. The rel- When such a declaration is provided, it ative protein quality value shall be de- shall be placed on the label adjacent to termined by dividing the subject prod- the statement of grams of protein and uct’s protein PER value by the PER aligned under the column headed ‘‘Per- value for casein. If the relative protein cent Daily Value,’’ and expressed to value is above 1.00, it shall be set at the nearest whole percent. However, 1.00. the percentage of the RDI for protein (iii) For the purpose of labeling with shall not be declared if the product is a percent of the DRV or RDI, a value of represented or purported to be for in- 50 grams of protein shall be the DRV fants and the protein quality value is for adults and children 4 or more years less than 40 percent of the reference of age, and the RDI for protein for chil- standard. dren less than 4 years of age, infants, (ii) The corrected amount of protein pregnant women, and lactating women (grams) per serving for products rep- shall be 16 grams, 14 grams, 60 grams, resented or purported to be for adults and 65 grams, respectively. and children 1 or more years of age is (8) Vitamins and minerals: A state- equal to the actual amount of protein ment of the amount per serving of the (grams) per serving multiplied by the vitamins and minerals as described in amino acid score corrected for protein this paragraph, calculated as a percent digestibility. If the corrected score is of the RDI and expressed as percent of above 1.00, then it shall be set at 1.00. Daily Value. The protein digestibility-corrected (i) For purposes of declaration of per- amino acid score shall be determined cent of Daily Value as provided for in by methods given in sections 5.4.1, 7.2.1, paragraphs (d) through (g) of this sec- and 8 in ‘‘Protein Quality Evaluation, tion, products represented or purported Report of the Joint FAO/WHO Expert to be for use by infants, children less Consultation on Protein Quality Eval- than 4 years of age, pregnant women, uation,’’ Rome, 1990, which is incor- or lactating women shall use the RDI’s porated by reference. Sections 5.4.1, that are specified for the intended 7.2.1, and 8 of the ‘‘Report of the Joint group. For products represented or pur- FAO/WHO Expert Consultation on Pro- ported to be for use by both infants and tein Quality Evaluation,’’ as published children under 4 years of age, the per- by the Food and Agriculture Organiza- cent of Daily Value shall be presented

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by separate declarations according to in nutrition labeling but may be de- paragraph (e) of this section based on clared by a zero or by the use of an as- the RDI values for infants from birth terisk (or other symbol) that refers to to 12 months of age and for children another asterisk (or symbol) that is under 4 years of age. Similarly, the placed at the bottom of the table and percent of Daily Value based on both that is followed by the statement the RDI values for pregnant women ‘‘Contains less than 2 percent of the and for lactating women shall be de- Daily Value of this (these) nutrient clared separately on products rep- (nutrients).’’ Alternatively, if vitamin resented or purported to be for use by A, vitamin C, calcium, or iron is both pregnant and lactating women. present in amounts less than 2 percent When such dual declaration is used on of the RDI, label declaration of the nu- any label, it shall be included in all la- trient(s) is not required if the state- beling, and equal prominence shall be ment ‘‘Not a significant source of given to both values in all such label- llll (listing the vitamins or mining. All other products shall use the erals omitted)’’ is placed at the bottom RDI for adults and children 4 or more of the table of nutrient values. years of age. (iv) The following RDI’s and nomen- (ii) The declaration of vitamins and clature are established for the follow- minerals as a percent of the RDI shall ing vitamins and minerals which are include vitamin A, vitamin C, calcium, essential in human nutrition: and iron, in that order, and shall in- Vitamin A, 5,000 International Units clude any of the other vitamins and Vitamin C, 60 milligrams minerals listed in paragraph (c)(8)(iv) Calcium, 1.0 gram of this section when they are added, or Iron, 18 milligrams when a claim is made about them. Vitamin D, 400 International Units Other vitamins and minerals need not Vitamin E, 30 International Units be declared if neither the nutrient nor the component is otherwise referred to Thiamin, 1.5 milligrams on the label or in labeling or advertis- Riboflavin, 1.7 milligrams ing and the vitamins and minerals are: Niacin, 20 milligrams (A) Required or permitted in a stand- Vitamin B6, 2.0 milligrams ardized food (e.g., thiamin, riboflavin, Folate, 0.4 milligram and niacin in enriched flour) and that Vitamin B12, 6 micrograms standardized food is included as an in- Biotin, 0.3 milligram gredient (i.e., component) in another Pantothenic acid, 10 milligrams product; or Phosphorus, 1.0 gram (B) Included in a product solely for Iodine, 150 micrograms technological purposes and declared Magnesium, 400 milligrams only in the ingredients statement. The Zinc, 15 milligrams declaration may also include any of the Copper, 2.0 milligrams other vitamins and minerals listed in (v) The following synonyms may be paragraph (c)(8)(iv) of this section added in parenthesis immediately fol- when they are naturally occurring in lowing the name of the nutrient or die- the food. The additional vitamins and tary component: minerals shall be listed in the order established in paragraph (c)(8)(iv) of this Vitamin C—Ascorbic acid section. Thiamin—Vitamin B1 (iii) The percentages for vitamins Riboflavin—Vitamin B2 and minerals shall be expressed to the Folate—Folacin nearest 2-percent increment up to and Calories—Energy including the 10-percent level, the (vi) A statement of the percent of vi- nearest 5-percent increment above 10 tamin A that is present as beta-caro- percent and up to and including the 50- tene may be declared voluntarily. percent level, and the nearest 10-per- When the vitamins and minerals are cent increment above the 50-percent listed in a single column, the state- level. Amounts of vitamins and min- ment shall be indented under the infor- erals present at less than 2 percent of mation on vitamin A. When vitamins the RDI are not required to be declared and minerals are arrayed horizontally,

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the statement of percent shall be pre- (iii) Information required in para- sented in parenthesis following the dec- graphs (d)(3), (d)(5), (d)(7), and (d)(8) of laration of vitamin A and the percent this section shall be in type size no of Daily Value of vitamin A in the smaller than 8 point. Except for the product (e.g., ‘‘Percent Daily Value: heading ‘‘Nutrition Facts,’’ the infor- Vitamin A 50 (90 percent as beta-caro- mation required in paragraphs (d)(4), tene)’’). When declared, the percent- (d)(6), and (d)(9) of this section and all ages shall be expressed in the same in- other information contained within the crements as are provided for vitamins nutrition label shall be in type size no and minerals in paragraph (c)(8)(iii) of smaller than 6 point. When provided, this section. the information described in paragraph (9) For the purpose of labeling with a (d)(10) of this section shall also be in percent of the DRV, the following type no smaller than 6 point. DRV’s are established for the following (iv) The headings required by para- food components based on the reference graphs (d)(2), (d)(4), and (d)(6) of this caloric intake of 2,000 calories: section (i.e., ‘‘Nutrition Facts,’’ Food component Unit of measurement DRV ‘‘Amount Per Serving,’’ and ‘‘% Daily Value*’’), the names of all nutrients Fat ...... grams (g) ...... 65 that are not indented according to re- Saturated fatty acids ...... do ...... 20 Cholesterol ...... milligrams (mg) ...... 300 quirements of paragraph (c) of this sec- Total carbohydrate ...... grams (g) ...... 300 tion (i.e., Calories, Total fat, Choles- Fiber ...... do ...... 25 terol, Sodium, Potassium, Total carbo- Sodium ...... milligrams (mg) ...... 2400 Potassium ...... do ...... 3500 hydrate, and Protein), and the percent- Protein ...... grams (g) ...... 50 age amounts required by paragraph (d)(7)(ii) of this section shall be high- (d)(1) Nutrient information specified lighted by bold or extra bold type or in paragraph (c) of this section shall be other highlighting (reverse printing is presented on products in the following not permitted as a form of highlight- format, except on products on which ing) that prominently distinguishes it dual columns of nutrition information from other information. No other infor- are declared as provided for in para- mation shall be highlighted. graph (e) of this section, on those prod- (v) A hairline rule that is centered ucts on which the simplified format is between the lines of text shall separate permitted to be used as provided for in ‘‘Amount Per Serving’’ from the cal- paragraph (f) of this section, on prod- orie statements required in paragraph ucts for infants and children less than (d)(5) of this section and shall separate 4 years of age as provided for in each nutrient and its corresponding § 381.500(c), and on products in packages percent of Daily Value required in that have a total surface area available paragraphs (d)(7)(i) and (d)(7)(ii) of this to bear labeling of 40 or less square section from the nutrient and percent inches as provided for in paragraph (g) of Daily Value above and below it. of this section. (i) The nutrition information shall be (2) The information shall be pre- set off in a box by use of hairlines and sented under the identifying heading of shall be all black or one color type, ‘‘Nutrition Facts’’ which shall be set in printed on a white or other neutral a type size larger than all other print contrasting background whenever prac- size in the nutrition label and, except tical. for labels presented according to the (ii) All information within the nutri- format provided for in paragraph (d)(11) tion label shall utilize: of this section, unless impractical, (A) A single easy-to-read type style, shall be set the full width of the infor- (B) Upper and lower case letters, mation provided under paragraph (d)(7) (C) At least one point leading (i.e., of this section. space between two lines of text) except (3) Information on serving size shall that at least four points leading shall immediately follow the heading. Such be utilized for the information required information shall include: by paragraphs (d)(7) and (d)(8) of this (i) ‘‘Serving Size’’: A statement of section, and the serving size as specified in para- (D) Letters should never touch. graph (b)(9) of this section.

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(ii) ‘‘Servings Per Container’’: The a DRV has been established, except number of servings per container, ex- that the percent for protein may be cept that this statement is not re- omitted as provided in paragraph (c)(7) quired on single-serving containers as of this section. The percent shall be defined in paragraph (b)(8) of this sec- calculated by dividing either the tion. amount declared on the label for each (4) A subheading ‘‘Amount Per Serv- nutrient or the actual amount of each ing’’ shall be separated from serving nutrient (i.e., before rounding) by the size information by a bar. DRV for the nutrient, except that the (5) Information on calories shall im- percent for protein shall be calculated mediately follow the heading ‘‘Amount as specified in paragraph (c)(7)(ii) of Per Serving’’ and shall be declared in this section. The numerical value shall one line, leaving sufficient space be- be followed by the symbol for percent tween the declaration of ‘‘Calories’’ (i.e., %). and ‘‘Calories from fat’’ to allow clear (8) Nutrient information for vitamins differentiation, or, if ‘‘Calories from and minerals shall be separated from saturated fat’’ is declared, in a column information on other nutrients by a with total ‘‘Calories’’ at the top, fol- bar and shall be arrayed horizontally lowed by ‘‘Calories from fat’’ (in- (e.g., Vitamin A 4%, Vitamin C 2%, dented), and ‘‘Calories from saturated Calcium 15%, Iron 4%) or may be listed fat’’ (indented). in two columns, except that when more (6) The column heading ‘‘% Daily than four vitamins and minerals are Value,’’ followed by an asterisk (e.g., declared, they may be declared verti- ‘‘% Daily Value*’’), shall be separated cally with percentages listed under the from information on calories by a bar. column headed ‘‘% Daily Value.’’ The position of this column heading (9) A footnote, preceded by an aster- shall allow for a list of nutrient names isk, shall be placed beneath the list of and amounts as described in paragraph vitamins and minerals and shall be sep- (d)(7) of this section to be to the left of, arated from that list by a hairline. and below, this column heading. The (i) The footnote shall state: Percent column heading ‘‘Percent Daily Daily Values are based on a 2,000 cal- Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may orie diet. Your daily values may be be substituted for ‘‘% Daily Value.’’ higher or lower depending on your cal- (7) Except as provided for in para- orie needs. graph (g) of this section, and except as permitted by § 381.500(d)(2), nutrient in- Calories 2,000 2,500 formation for both mandatory and any Total fat ...... Less than ...... 65 g 80 g voluntary nutrients listed in paragraph Saturated fat .... Less than ...... 20 g 25 g (c) of this section that are to be de- Cholesterol ...... Less than ...... 300 mg 300 mg clared in the nutrition label, except vi- Sodium ...... Less than ...... 2400 mg 2400 mg Total carbo- ...... 300 g 375 g tamins and minerals, shall be declared hydrate. as follows: Dietary fiber ...... 25 g 30 g (i) The name of each nutrient, as specified in paragraph (c) of this sec- (ii) If the percent of Daily Value is tion, shall be given in a column and given for protein in the Percent of followed immediately by the quan- Daily Value column as provided in titative amount by weight for that nu- paragraph (d)(7)(ii) of this section, pro- trient appended with a ‘‘g’’ for grams tein shall be listed under dietary fiber, or ‘‘mg’’ for milligrams. and a value of 50 g shall be inserted on (ii) A listing of the percent of the the same line in the column headed DRV as established in paragraphs ‘‘2,000’’ and value of 65 g in the column (c)(7)(iii) and (c)(9) of this section shall headed ‘‘2,500.’’ be given in a column aligned under the (iii) If potassium is declared in the heading ‘‘% Daily Value’’ established column described in paragraph (d)(7)(i) in paragraph (d)(6) of this section with of this section, potassium shall be list- the percent expressed to the nearest ed under sodium and the DRV estab- whole percent for each nutrient de- lished in paragraph (c)(9) of this sec- clared in the column described in para- tion shall be inserted on the same line graph (d)(7)(i) of this section for which in the numeric columns.

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(iv) The abbreviations established in mins and minerals to be declared or the paragraph (g)(2) of this section may be information required in paragraph used within the footnote. (d)(9) of this section, the remaining in- (10) Caloric conversion information formation may be moved to the right on a per-gram basis for fat, carbo- and set off by a line that distinguishes hydrate, and protein may be presented it and sets it apart from the percent of beneath the information required in Daily Value information given to the paragraph (d)(9), separated from that left. The caloric conversion informa- information by a hairline. This infor- tion provided for in paragraph (d)(10) of mation may be presented horizontally this section may be presented beneath (i.e., ‘‘Calories per gram: Fat 9, Carbo- either side or along the full length of hydrate 4, Protein 4’’) or vertically in the nutrition label. columns. (iii) If there is not sufficient continu- (11)(i) If the space beneath the infor- ous vertical space (i.e., approximately mation on vitamins and minerals is not 3 inches) to accommodate the required adequate to accommodate the informa- components of the nutrition label up to tion required in paragraph (d)(9) of this section, the information required in and including the mandatory declara- paragraph (d)(9) may be moved to the tion of iron, the nutrition label may be right of the column required in para- presented in a tabular display in which graph (d)(7)(ii) of this section and set the footnote required by paragraph off by a line that distinguishes it and (d)(9) of the section is given to the far sets it apart from the percent of Daily right of the label, and additional vita- Value information. The caloric conver- mins and minerals beyond the four sion information provided for in para- that are required (i.e., vitamin A, vita- graph (d)(10) of this section may be pre- min C, calcium, and iron) are arrayed sented beneath either side or along the horizontally following declarations of full length of the nutrition label. the required vitamins and minerals. (ii) If the space beneath the manda- (12) The following sample label illus- tory declaration of iron is not adequate trates the provisions of paragraph (d) to accommodate any remaining vita- of this section:

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(13)(i) Nutrition labeling on the outer Amount in § 381.412(b) shall be to the label of packages of poultry products left of the numeric columns. that contain two or more products in (2) When the dual labeling is pre- the same packages (e.g., variety packs) sented for two or more forms of the or of packages that are used inter- same product, for combinations of changeably for the same type of food foods, or for different units, total cal- (e.g., poultry salad containers) may use ories and calories from fat (and cal- an aggregate display. ories from saturated fat, when de- (ii) Aggregate displays shall comply clared) shall be listed in a column and with format requirements of paragraph indented as specified in paragraph (d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged and under the name of each food. according to the label serving size (14) When nutrition labeling appears based on the Reference Amount in in a second language, the nutrition in- § 381.412(b). formation may be presented in a sepa- (i) Quantitative information by rate nutrition label for each language weight may be included for other forms or in one nutrition label with the infor- of the product represented by the addi- mation in the second language follow- tional column(s) either immediately ing that in English. Numeric char- adjacent to the required quantitative acters that are identical in both lan- information by weight for the product guages need not be repeated (e.g., ‘‘Pro- as packaged and according to the label tein/Proteinas 2 g’’). All required infor- serving size based on the Reference mation must be included in both languages. Amount in § 381.412(b) or as a footnote. (e) Nutrition information may be pre- (A) If such additional quantitative sented for two or more forms of the information is given immediately adja- same product (e.g., both ‘‘raw’’ and cent to the required quantitative infor- ‘‘cooked’’) or for common combina- mation, it shall be declared for all nu- tions of foods as provided for in para- trients listed and placed immediately graph (b) of this section, or for dif- following and differentiated from the ferent units (e.g., per 100 grams) as pro- required quantitative information vided for in paragraph (b) of this sec- (e.g., separated by a comma). Such in- tion, or for two or more groups for formation shall not be put in a sepa- which RDI’s are established (e.g., both rate column. infants and children less than 4 years (B) If such additional quantitative in- of age) as provided for in paragraph formation is given in a footnote, it (c)(8)(i) of this section. When such dual shall be declared in the same order as labeling is provided, equal prominence the nutrients are listed in the nutri- shall be given to both sets of values. tion label. The additional quantitative Information shall be presented in a for- information may state the total nutri- mat consistent with paragraph (d) of ent content of the product identified in this section, except that: the second column or the nutrient (1) Following the subheading of amounts added to the product as ‘‘Amount Per Serving,’’ there shall be packaged for only those nutrients that two or more column headings accu- are present in different amounts than rately describing the forms of the same the amounts declared in the required product (e.g., ‘‘raw’’ and ‘‘roasted’’), quantitative information. The footnote the combinations of foods, the units, or shall clearly identify which amounts the RDI groups that are being declared. are declared. Any subcomponents de- The column representing the product clared shall be listed parenthetically as packaged and according to the label after principal components (e.g., 1⁄2 cup serving size based on the Reference skim milk contributes an additional 40

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calories, 65 mg sodium, 6 g total carbo- (4) Information required in para- hydrate (6 g sugars), and 4 g protein). graphs (d)(7)(ii) and (d)(8) of this sec- (ii) Total fat and its quantitative tion shall be presented under the sub- amount by weight shall be followed by heading ‘‘% DAILY VALUE’’ and in an asterisk (or other symbol) (e.g., columns directly under the column ‘‘Total fat (2 g)*’’) referring to another headings set forth in paragraph (e)(1) of asterisk (or symbol) at the bottom of this section. the nutrition label identifying the (5) The following sample label illus- form(s) of the product for which quan- trates the provisions of paragraph (e) titative information is presented. of this section:

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(f)(1) Nutrition information may be tion is not required. When the footnote presented in a simplified format as set is omitted, an asterisk shall be placed forth herein when any required nutri- at the bottom of the label followed by ents, other than the core nutrients the statement ‘‘Percent Daily Values (i.e., calories, total fat, sodium, total are based on a 2,000 calorie diet’’ and, if carbohydrate, and protein), are present the term ‘‘Daily Value’’ is not spelled in insignificant amounts. An insignifi- out in the heading, a statement that cant amount shall be defined as that ‘‘DV’’ represents ‘‘Daily Value.’’ amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 381.402(a) by one or more of the follow- clude information on the following nu- ing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient Serving size—Serv size values and that is followed by the Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat graph (g) of this section and in Polyunsaturated fat—Polyunsat fat § 381.500(c) and (d), nutrient informa- Cholesterol—Cholest tion declared in the simplified format Total carbohydrate—Total carb shall be presented in the same manner Dietary fiber—Fiber as specified in paragraphs (d) or (e) of Soluble fiber—Sol fiber this section, except that the footnote Insoluble fiber—Insol fiber required in paragraph (d)(9) of this sec- Sugar alcohol—Sugar alc

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Other carbohydrate—Other carb is incorporated as it exists on the date (3) Omitting the footnote required in of approval. This incorporation by ref- paragraph (d)(9) of this section and erence was approved by the Director of placing another asterisk at the bottom the FEDERAL REGISTER in accordance of the label followed by the statement with 5 U.S.C. 552(a) and 1 CFR part 51. ‘‘Percent Daily Values are based on a Copies may be purchased from the 2,000 calorie diet’’ and, if the term AOAC International, 2200 Wilson Blvd., ‘‘Daily Value’’ is not spelled out in the Suite 400, Arlington, VA 22201. It is also heading, a statement that ‘‘DV’’ rep- available for inspection at the Office of resents ‘‘Daily Value.’’ the Federal Register Information Cen- (4) Presenting the required informa- ter, suite 700, 800 North Capitol Street, tion on any other label panel. NW., Washington, DC. (h) Compliance with this section (3) Two classes of nutrients are de- shall be determined as follows: fined for purposes of compliance: (1) A production lot is a set of food (i) Class I. Added nutrients in for- production consumer units that are tified or fabricated foods; and from one production shift. Alter- (ii) Class II. Naturally occurring (in- natively, a collection of consumer digenous) nutrients. If any ingredient units of the same size, type, and style which contains a naturally occurring produced under conditions as nearly (indigenous) nutrient is added to a uniform as possible, designated by a food, the total amount of such nutrient common container code or marking, in the final food product is subject to constitutes a production lot. Class II requirements unless the same (2) The sample for nutrient analysis nutrient is also added, which would shall consist of a composite of a mini- make the total amount of such nutri- mum of six consumer units, each from ent subject to Class I requirements. a production lot. Alternatively, the (4) A product with a label declaration sample for nutrient analysis shall con- of a vitamin, mineral, protein, total sist of a composite of a minimum of six carbohydrate, dietary fiber, other car- consumer units, each randomly chosen bohydrate, polyunsaturated or to be representative of a production monounsaturated fat, or potassium lot. In each case, the units may be indi- shall be deemed to be misbranded vidually analyzed and the results of the under section 4(h) of the Poultry Prod- analyses averaged, or the units would ucts Inspection Act (21 U.S.C. 453(h)(4)) be composited and the composite ana- unless it meets the following require- lyzed. In both cases, the results, wheth- ments: er an average or a single result from a (i) Class I vitamin, mineral, protein, composite, will be considered by the dietary fiber, or potassium. The nutri- Agency to be the nutrient content of a ent content of the composite is at least composite. All analyses shall be per- equal to the value for that nutrient deformed by appropriate methods and clared on the label. procedures used by the Department for (ii) Class II vitamin, mineral, pro- each nutrient in accordance with the tein, total carbohydrate, dietary fiber, ‘‘Chemistry Laboratory Guidebook,’’ other carbohydrate, polyunsaturated or, if no USDA method is available and or monounsaturated fat, or potassium. appropriate for the nutrient, by appro- The nutrient content of the composite priate methods for the nutrient in ac- is at least equal to 80 percent of the cordance with the 1990 edition of the value for that nutrient declared on the ‘‘Official Methods of Analysis’’ of the label; Provided, That no regulatory ac- AOAC International, formerly Associa- tion will be based on a determination tion of Official Analytical Chemists, of a nutrient value which falls below 15th ed., which is incorporated by ref- this level by an amount less than the erence, unless a particular method of variability generally recognized for the analysis is specified in § 381.409(c), or, if analytical method used in that product no USDA, AOAC, or specified method is at the level involved, and inherent nu- available and appropriate, by other re- trient variation in a product. liable and appropriate analytical pro- (5) A product with a label declaration cedures as so determined by the Agen- of calories, sugars, total fat, saturated cy. The ‘‘Official Methods of Analysis’’ fat, cholesterol, or sodium shall be

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deemed to be misbranded under section § 381.410–381.411 [Reserved] 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)(4)) if the nutrient § 381.412 Reference amounts customar- content of the composite is greater ily consumed per eating occasion. than 20 percent in excess of the value (a) The general principles followed in for that nutrient declared on the label; arriving at the reference amounts cus- Provided, That no regulatory action tomarily consumed per eating occasion will be based on a determination of a (Reference Amount(s)), as set forth in nutrient value which falls above this paragraph (b) of this section, are: level by an amount less than the varia- (1) The Reference Amounts are cal- bility generally recognized for the ana- culated for persons 4 years of age or lytical method used in that product at older to reflect the amount of food cus- the level involved, and inherent nutri- tomarily consumed per eating occasion ent variation in a product. by persons in this population group. These Reference Amounts are based on (6) The amount of a vitamin, mineral, data set forth in appropriate national protein, total carbohydrate, dietary food consumption surveys. fiber, other carbohydrate, polyunsat- (2) The Reference Amounts are cal- urated or monounsaturated fat, or po- culated for an infant or child under 4 tassium may vary over labeled years of age to reflect the amount of amounts within good manufacturing food customarily consumed per eating practice. The amount of calories, sug- occasion by infants up to 12 months of ars, total fat, saturated fat, choles- age or by children 1 through 3 years of terol, or sodium may vary under la- age, respectively. These Reference beled amounts within good manufac- Amounts are based on data set forth in turing practice. appropriate national food consumption (7) Compliance will be based on the surveys. Such Reference Amounts are metric measure specified in the label to be used only when the product is statement of serving size. specially formulated or processed for (8) The management of the establish- use by an infant or by a child under 4 ment must maintain records to support years of age. the validity of nutrient declarations (3) An appropriate national food con- contained on product labels. Such sumption survey includes a large sam- records shall be made available to the ple size representative of the demo- inspector or any duly authorized rep- graphic and socioeconomic characteris- resentative of the Agency upon re- tics of the relevant population group and must be based on consumption quest. data under actual conditions of use. (9) The compliance provisions set (4) To determine the amount of food forth in paragraph (h)(1) through (8) of customarily consumed per eating occa- this section shall not apply to single- sion, the mean, median, and mode of ingredient, raw poultry products, in- the consumed amount per eating occa- cluding those that have been pre- sion were considered. viously frozen, when nutrition labeling (5) When survey data were insuffi- is based on the most current represent- cient, FSIS took various other sources ative data base values contained in of information on serving sizes of food USDA’s National Nutrient Data Bank into consideration. These other sources or its published form, the Agriculture of information included: Handbook No. 8 series. (i) Serving sizes used in dietary guid- (Paperwork requirements were approved by ance recommendations or rec- the Office of Management and Budget under ommended by other authoritative sys- control number 0583–0088.) tems or organizations; [58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, (ii) Serving sizes recommended in 1993, as amended at 58 FR 47628, Sept. 10, comments; 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. (iii) Serving sizes used by manufac- 3, 1995; 60 FR 10304, Feb. 24, 1995] turers and grocers; and

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(iv) Serving sizes used by other coun- (b) The following Product Categories tries. and Reference Amounts shall be used (6) Because they reflect the amount as the basis for determining serving customarily consumed, the Reference sizes for specific products: Amount and, in turn, the serving size declared on the product label are based TABLE 1.ÐREFERENCE AMOUNTS CUSTOMARILY on only the edible portion of food, and CONSUMED PER EATING OCCASIONÐINFANT not bone, seed, shell, or other inedible AND TODDLER FOODS 1,2,3 components. Reference (7) The Reference Amount is based on Product category amount the major intended use of the product Infant & Toddler Foods: (e.g., a mixed dish measurable with a Dinner Dry Mix ...... 15 g cup as a main dish and not as a side Dinner, ready-to-serve, strained type ...... 60 g dish). Dinner, soups, ready-to-serve junior type ...... 110 g (8) The Reference Amounts for prod- Dinner, stew or soup ready-to-serve toddlers 170 g Plain poultry and poultry sticks, ready-to-serve 55 g ucts that are consumed as an ingredi- 1 These values represent the amount of food customarily ent of other products, but that may consumed per eating occasion and were primarily derived also be consumed in the form in which from the 1977±1978 and the 1987±1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of they are purchased (e.g., ground poul- Agriculture. try), are based on use in the form pur- 2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost chased. ready-to-serve form of the product (i.e., heat and serve). If not (9) FSIS sought to ensure that foods listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make that have similar dietary usage, prod- one Reference Amount of the prepared form. uct characteristics, and customarily 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure consumed amounts have a uniform Ref- most appropriate to their specific product using the proce- erence Amount. dures established by the regulation.

TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5

Reference Amount Reference Amount Product category Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young with poul- 110 g n/a try). Salad and potato toppers; e.g., poultry bacon bits ...... 7 g n/a Bacon; e.g., poultry breakfast strips...... 15 g 26 g = bacon. 18 g = breakfast strips Dried; e.g., poultry jerky, dried poultry, poultry sausage products with a 30 g n/a moisture/protein ratio of less than 2:1. Snacks; e.g., poultry snack food sticks ...... 30 g n/a Luncheon products, poultry bologna, poultry Canadian style bacon, 55 g n/a poultry crumbles, poultry luncheon loaf, potted poultry products, poultry taco filings. Linked poultry sausage products, poultry franks, poultry Polish sausage, 55 g n/a smoked or pickled poultry meat, poultry smoked sausage. 69 g = uncooked sausage. Entrees without sauce, poultry cuts, ready to cook poultry cuts, includ- 85 g 114g ing marinated, tenderized, injected cuts of poultry, poultry corn dogs, poultry croquettes, poultry fritters, cured poultry ham products, adult pureed poultry. Canned poultry, canned chicken, canned 4 turkey ...... 55 g n/a Entrees with sauce, turkey and gravy ...... 140 g n/a Mixed dishes NOT measurable with a cup; 5 e.g., poultry burrito, poultry 140 g (plus 55 g for prod- n/a enchiladas, poultry pizza, poultry quiche, all types of poultry sand- ucts toppings) wiches, cracker and poultry lunch-type packages, poultry gyro, poultry stromboli, poultry frank on a bun, poultry burger on a bun, poultry taco, chicken cordon bleu, poultry calzone, stuffed vegetables with poultry, poultry kabobs. Mixed dishes, measurables with a cup; e.g., poultry casserole, maca- 1 cup n/a roni and cheese with poultry, poultry pot pie, poultry spaghetti with sauce, poultry chili, poultry chili with beans, poultry hash, creamed dried poultry, poultry ravioli in sauce, poultry a la king, poultry stew, poultry goulash, poultry lasagna, poultry-filled pasta. SaladsÐpasta or potato, potato salad with poultry, macaroni and poul- 140 g n/a try salad. SaladsÐall other, poultry salads, chicken salad, turkey salad ...... 100 g n/a

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TABLE 2.ÐREFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASIONÐGENERAL FOOD SUPPLY 1,2,3,4,5ÐContinued

Reference Amount Reference Amount Product category Ready-to-serve Ready-to-cook

SoupsÐall varieties ...... 245 g n/a Major main entree type sauce; e.g., spaghetti sauce with poultry ...... 125 g n/a Minor main entree sauce; e.g., pizza sauce with poultry, gravy ...... 1¤4 cup n/a Seasoning mixes dry, freeze dry, dehydrated, concentrated soup mixes, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with poultry. As reconstituted: Amount to make one Reference Amount of the final dish; e.g.Ð Gravy ...... 1¤4 cup n/a Major main entree type sauce ...... 125 g n/a Soup ...... 245 g n/a Entree measurable with a cup ...... 1 cup n/a 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977±78 and the 1987±88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be a sauce topping.

(c) For products that have no Ref- units, the weights of the appropriate erence Amount listed in paragraph (b) volumes should be used (e.g., grams of of this section for the unprepared or one ingredient plus gram weight of ta- the prepared form of the product and blespoons of a second ingredient). that consist of two or more foods (d) If a product requires further prep- packaged and presented to be aration, e.g., cooking or the addition of consumed together (e.g., poultry lunch water or other ingredients, and if para- meat with cheese and crackers), the graph (b) of this section provides a Ref- Reference Amount for the combined erence Amount for the product in the product shall be determined using the prepared form, then the Reference following rules: Amount for the unprepared product (1) For bulk products, the Reference shall be determined using the following Amount for the combined product shall rules: be the Reference Amount, as estab- (1) Except as provided for in para- lished in paragraph (b) of this section, graph (d)(2) of this section, the Ref- for the ingredient that is represented erence Amount for the unprepared as the main ingredient plus propor- product shall be the amount of the un- tioned amounts of all minor ingredi- prepared product required to make the ents. Reference Amount for the prepared (2) For products where the ingredient product as established in paragraph (b) represented as the main ingredient is of this section. one or more discrete units, the Ref- (2) For products where the entire erence Amount for the combined prod- contents of the package is used to pre- uct shall be either the number of small pare one large discrete unit usually di- discrete units or the fraction of the vided for consumption, the Reference large discrete unit that is represented Amount for the unprepared product as the main ingredient that is closest shall be the amount of the unprepared to the Reference Amount for that in- product required to make the fraction gredient as established in paragraph (b) of the large discrete unit closest to the of this section plus proportioned Reference Amount for the prepared amounts of all minor ingredients. product as established in paragraph (b) (3) If the Reference Amounts are in of this section. compatible units, they shall be (e) The Reference Amount for an imi- summed (e.g., ingredients in equal vol- tation or substitute product or altered umes such as tablespoons). If the Ref- product as defined in § 381.413(d), such erence Amounts are in incompatible as a ‘‘low calorie’’ version, shall be the

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same as for the product for which it is with supporting documentation, sub- offered as a substitute. mitted to the Agency under this sec- (f) The Reference Amounts set forth tion will be governed by the rules spec- in paragraphs (b) through (e) of this ified in subchapter D, title 9. section shall be used in determining (4) Data accompanying the labeling whether a product meets the criteria application, such as food consumption for nutritional claims. If the serving data, shall be submitted on separate size declared on the product label dif- sheets, suitably identified. If such data fers from the Reference Amount, and has already been submitted with an the product meets the criteria for the earlier labeling application from the claim only on the basis of the Ref- applicant, the present labeling applica- erence Amount, the claim shall be fol- tion must provide the data. lowed by a statement that sets forth (5) The labeling application must be the basis on which the claim is made. signed by the applicant or by his or her That statement shall include the Ref- attorney or agent, or (if a corporation) erence Amount as it appears in para- by an authorized official. graph (b) of this section followed, in (6) The labeling application shall in- parenthesis, by the amount in common clude a statement signed by the person household measure if the Reference responsible for the labeling applica- Amount is expressed in measures other tion, that to the best of his or her than common household measures. knowledge, it is a representative and (g) The Administrator, on his or her balanced submission that includes un- own initiative or on behalf of any in- favorable information, as well as favor- terested person who has submitted a able information, known to him or her labeling application, may issue a pro- pertinent to the evaluation of the la- posal to establish or amend a Product beling application. Category or Reference Amount identi- (7) Labeling applications for a new fied in paragraph (b) of this section. Reference Amount and/or Product Cat- (1) Labeling applications and sup- egory shall be accompanied by the fol- porting documentation to be filed lowing data which shall be submitted under this section shall be submitted in the following form to the Director, in quadruplicate, except that the sup- Food Labeling Division, Regulatory porting documentation may be submit- Programs, Food Safety and Inspection ted on a computer disc copy. If any Service, Washington, DC 20250: part of the material submitted is in a foreign language, it shall be accom- ———————————————————————— panied by an accurate and complete (Date) English translation. The labeling appli- The undersigned, llllll submits this cation shall state the applicant’s post labeling application pursuant to 9 CFR office address. 381.412 with respect to Reference Amount (2) Pertinent information will be con- and/or Product Category. sidered as part of an application on the Attached hereto, in quadruplicate, or on a basis of specific reference to such infor- computer disc copy, and constituting a part mation submitted to and retained in of this labeling application, are the following: the files of the Food Safety and Inspec- (i) A statement of the objective of the lation Service. However, any reference to beling application; unpublished information furnished by a (ii) A description of the product; person other than the applicant will (iii) A complete sample product label in- not be considered unless use of such including nutrition label, using the format es- formation is authorized (with the un- tablished by regulation; derstanding that such information may (iv) A description of the form in which the in whole or part be subject to release product will be marketed; to the public) in a written statement (v) The intended dietary uses of the prod- signed by the person who submitted it. uct with the major use identified (e.g., turkey as a luncheon meat); Any reference to published information (vi) If the intended use is primarily as an should be accompanied by reprints or ingredient in other foods, list of foods or food photostatic copies of such references. categories in which the product will be used (3) The availability for public disclo- as an ingredient with information on the sure of labeling applications, along prioritization of the use;

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(vii) The population group for which the (A) Sampled population selected should be product will be offered for use (e.g., infants, representative of the demographic and socio- children under 4 years of age); economic characteristics of the target popu- (viii) The names of the most closely-relat- lation group for which the food is intended. ed products (or in the case of foods for spe- (B) Sample size (i.e., number of eaters) cial dietary use and imitation or substitute should be large enough to give reliable esti- foods, the names of the products for which mates for customarily consumed amounts. they are offered as substitutes); (C) The study protocol should identify po- (ix) The suggested Reference Amount (the tential biases and describe how potential bi- amount of edible portion of food as ases are controlled for or, if not possible to consumed, excluding bone, skin or other in- control, how they affect interpretation of re- edible components) for the population group sults. for which the product is intended with full (D) The methodology used to collect or description of the methodology and proce- process data including study design, sam- dures that were used to determine the sug- pling procedures, materials used (e.g., ques- gested Reference Amount. In determining tionnaire, interviewer’s manual), procedures the Reference Amount, general principles used to collect or process data, methods or and factors in paragraph (a) of this section procedures used to control for unbiased esti- should be followed. mates, and procedures used to correct for (x) The suggested Reference Amount shall nonresponse, should be fully documented. be expressed in metric units. Reference (xiii) A statement concerning the feasibil- Amounts for foods shall be expressed in ity of convening associations, corporations, grams except when common household units consumers, and other interested parties to such as cups, tablespoons, and teaspoons are engage in negotiated rulemaking to develop more appropriate or are more likely to pro- a proposed rule. mote uniformity in serving sizes declared on product labels. For example, common house- Yours very truly, hold measures would be more appropriate if Applicant ——————————————— products within the same category differ By ——————————————————— substantially in density such as mixed dishes measurable with a cup. (Indicate authority) (A) In expressing the Reference Amount in (8) Upon receipt of the labeling appli- grams, the following general rules shall be cation and supporting documentation, followed: the applicant shall be notified, in writ- (1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 ing, of the date on which the labeling grams increment. application was received. Such notice (2) For quantities less than 10 grams, exact shall inform the applicant that the la- gram weights shall be used. beling application is undergoing Agen- (B) [Reserved] cy review and that the applicant shall (xi) A labeling application for a new sub- subsequently be notified of the Agen- category of food with its own Reference cy’s decision to consider for further re- Amount shall include the following addi- view or deny the labeling application. tional information: (A) Data that demonstrate that the new (9) Upon review of the labeling appli- subcategory of food will be consumed in cation and supporting documentation, amounts that differ enough from the Ref- the Agency shall notify the applicant, erence Amount for the parent category to in writing, that the labeling applica- warrant a separate Reference Amount. Data tion is either being considered for fur- must include sample size, and the mean, ther review or that it has been sum- standard deviation, median, and modal marily denied by the Administrator. consumed amount per eating occasion for the product identified in the labeling appli- (10) If the labeling application is cation and for other products in the cat- summarily denied by the Adminis- egory. All data must be derived from the trator, the written notification shall same survey data. state the reasons therefor, including (B) Documentation supporting the dif- why the Agency has determined that ference in dietary usage and product charac- the proposed Reference Amount and/or teristics that affect the consumption size Product Category is false or mislead- that distinguishes the product identified in ing. The notification letter shall in- the labeling application from the rest of the form the applicant that the applicant products in the category. (xii) In conducting research to collect or may submit a written statement by process food consumption data in support of way of answer to the notification, and the labeling application, the following gen- that the applicant shall have the right eral guidelines should be followed. to request a hearing with respect to

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the merits or validity of the Adminis- (i) If the Reference Amount and/or trator’s decision to deny the use of the Product Category is denied by the Ad- proposed Reference Amount and/or ministrator, the Agency shall notify Product Category. the applicant, in writing, of the basis (i) If the applicant fails to accept the for the denial, including the reason determination of the Administrator why the Reference Amount and/or and files an answer and requests a Product Category on the labeling was hearing, and the Administrator, after determined by the Agency to be false review of the answer, determines the or misleading. The notification letter initial determination to be correct, the shall also inform the applicant that the Administrator shall file with the Hear- applicant may submit a written state- ing Clerk of the Department the notifi- ment by way of answer to the notifica- cation, answer, and the request for a tion, and that the applicant shall have hearing, which shall constitute the the right to request a hearing with re- complaint and answer in the proceed- spect to the merits or validity of the ing, which shall thereafter be con- Administrator’s decision to deny the ducted in accordance with the Depart- use of the proposed Reference Amount ment’s Uniform Rules of Practice. and/or Product Category. (ii) The hearing shall be conducted (A) If the applicant fails to accept before an administrative law judge the determination of the Adminis- with the opportunity for appeal to the trator and files an answer and requests Department’s Judicial Officer, who a hearing, and the Administrator, after shall make the final determination for the Secretary. Any such determination review of the answer, determines the by the Secretary shall be conclusive initial determination to be correct, the unless, within 30 days after receipt of Administrator shall file with the Hear- notice of such final determination, the ing Clerk of the Department the notifi- applicant appeals to the United States cation, answer, and the request for a Court of Appeals for the circuit in hearing, which shall constitute the which the applicant has its principal complaint and answer in the proceed- place of business or to the United ing, which shall thereafter be con- States Court of Appeals for the District ducted in accordance with the Depart- of Columbia Circuit. ment’s Uniform Rules of Practice. (11) If the labeling application is not (B) The hearing shall be conducted summarily denied by the Adminis- before an administrative law judge trator, the Administrator shall publish with the opportunity for appeal to the in the FEDERAL REGISTER a proposed Department’s Judicial Officer, who rule to amend the regulations to au- shall make the final determination for thorize the use of the Reference the Secretary. Any such determination Amount and/or Product Category. The by the Secretary shall be conclusive proposal shall also summarize the la- unless, within 30 days after receipt of beling application, including where the notice of such final determination, the supporting documentation can be re- applicant appeals to the United States viewed. The Administrator’s proposed Court of Appeals for the circuit in rule shall seek comment from consum- which the applicant has its principal ers, the industry, consumer and indus- place of business or to the United try groups, and other interested per- States Court of Appeals for the District sons on the labeling application and of Columbia. the use of the proposed Reference (ii) If the Reference Amount and/or Amount and/or Product Category. Product Category is approved, the After public comment has been received and reviewed by the Agency, the Agency shall notify the applicant, in Administrator shall make a determina- writing, and shall also publish in the tion on whether the proposed Reference FEDERAL REGISTER a final rule amend- Amount and/or Product Category shall ing the regulations to authorize the be approved for use on the labeling of poultry products.

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use of the Reference Amount and/or nutrition labeling, and that appears as Product Category. part of the nutrition label, is not a nu- (Paperwork requirements were approved by trient content claim and is not subject the Office of Management and Budget under to the requirements of this section. If control number 0583–0088.) such information is declared elsewhere [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, on the label or in labeling, it is a nutri- 1993, as amended at 58 FR 47628, Sept. 10, ent content claim and is subject to the 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. requirements for nutrient content 3, 1995] claims. (d) A ‘‘substitute’’ product is one § 381.413 Nutrient content claims; general principles. that may be used interchangeably with another product that it resembles, i.e., (a) This section applies to poultry that it is organoleptically, physically, products that are intended for human and functionally (including shelf life) consumption and that are offered for similar to, and that it is not nutrition- sale. ally inferior to unless it is labeled as (b) A claim which, expressly or by an ‘‘imitation.’’ implication, characterizes the level of (1) If there is a difference in perform- a nutrient (nutrient content claim) of ance characteristics that materially the type required in nutrition labeling limits the use of the product, the prod- pursuant to § 381.409, may not be made uct may still be considered a substitute on a label or in labeling of that product if the label includes a disclaimer adja- unless the claim is made in accordance cent to the most prominent claim as with the applicable provisions in this defined in paragraph (j)(2)(iii) of this subpart. (1) An expressed nutrient content section, informing the consumer of claim is any direct statement about such difference (e.g., ‘‘not rec- the level (or range) of a nutrient in the ommended for frying’’). product, e.g., ‘‘low sodium’’ or ‘‘con- (2) This disclaimer shall be in easily tains 100 calories.’’ legible print or type and in a size no (2) An implied nutrient content claim less than that required by § 381.121(c) is any claim that: for the net quantity of contents state- (i) Describes the product or an ingre- ment, except where the size of the dient therein in a manner that sug- claim is less than two times the re- gests that a nutrient is absent or quired size of the net quantity of con- present in a certain amount (e.g., tents statement, in which case the dis- ‘‘high in oat bran’’); or claimer statement shall be no less than (ii) Suggests that the product, be- one-half the size of the claim but no cause of its nutrient content, may be smaller than 1⁄16-inch minimum height, useful in maintaining healthy dietary except as permitted by § 381.500(d)(2). practices and is made in association (e)(1) Because the use of a ‘‘free’’ or with an explicit claim or statement ‘‘low’’ claim before the name of a prod- about a nutrient (e.g., ‘‘healthy, con- uct implies that the product differs tains 3 grams (g) of fat’’). from other products of the same type (3) Except for claims regarding vita- by virtue of its having a lower amount mins and minerals described in para- of the nutrient, only products that graph (q)(3) of this section, no nutrient have been specially processed, altered, content claims may be made on prod- formulated, or reformulated so as to ucts intended specifically for use by in- lower the amount of the nutrient in fants and children less than 2 years of the product, remove the nutrient from age unless the claim is specifically pro- the product, or not include the nutri- vided for in subpart Y of this part. ent in the product, may bear such a (4) Reasonable variations in the spell- claim (e.g., ‘‘low sodium chicken noo- ing of the terms defined in applicable dle soup’’). provisions in this subpart and their (2) Any claim for the absence of a nu- synonyms are permitted provided these trient in a product, or that a product is variations are not misleading (e.g., low in a nutrient when the product has ‘‘hi’’ or ‘‘lo’’). not been specially processed, altered, (c) Information that is required or formulated, or reformulated to qualify permitted by § 381.409 to be declared in for that claim shall indicate that the

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product inherently meets the criteria (e.g., ‘‘100 calories’’ or ‘‘5 grams of and shall clearly refer to all products fat’’), in which case no disclaimer is re- of that type and not merely to the par- quired. ticular brand to which the labeling at- (4) ‘‘Percent fat free’’ claims are not taches (e.g., ‘‘chicken breast meat, a authorized by this paragraph. Such low sodium food’’). claims shall comply with § 381.462(b)(6). (f) A nutrient content claim shall be (j) A product may bear a statement in type size and style no larger than that compares the level of a nutrient in two times that of the statement of the product with the level of a nutrient identity and shall not be unduly promi- in a reference product. These state- nent in type style compared to the ments shall be known as ‘‘relative statement of identity. claims’’ and include ‘‘light,’’ ‘‘re- (g) Labeling information required in duced,’’ ‘‘less’’ (or ‘‘fewer’’), and §§ 381.413, 381.454, 381.456, 381.460, 381.461, ‘‘more’’ claims. 381.462, and 381.480, whose type size is (1) To bear a relative claim about the not otherwise specified, is required to level of a nutrient, the amount of that be in letters and/or numbers no less nutrient in the product must be com- than 1⁄16 inch in height, except as per- pared to an amount of nutrient in an mitted by § 381.500(d)(2). appropriate reference product as speci- (h) [Reserved] fied in this paragraph (j). (i) Except as provided in § 381.409 or in (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and paragraph (q)(3) of this section, the ‘‘more’’ claims, the reference product label or labeling of a product may con- may be a dissimilar product within a tain a statement about the amount or product category that can generally be percentage of a nutrient if: substituted for one another in the diet (1) The use of the statement on the or a similar product. product implicitly characterizes the (B) For ‘‘light,’’ ‘‘reduced,’’ and level of the nutrient in the product and ‘‘added’’ claims, the reference product is consistent with a definition for a shall be a similar product, and claim, as provided in subpart Y of this (ii)(A) For ‘‘light’’ claims, the ref- part, for the nutrient that the label ad- erence product shall be representative dresses. Such a claim might be, ‘‘less of the type of product that includes the than 10 g of fat per serving;’’ product that bears the claim. The nu- (2) The use of the statement on the trient value for the reference product product implicitly characterizes the shall be representative of a broad base level of the nutrient in the product and of products of that type; e.g., a value in is not consistent with such a defini- a representative, valid data base; an tion, but the label carries a disclaimer average value determined from the top adjacent to the statement that the three national (or regional) brands, a product is not ‘‘low’’ in or a ‘‘good market basket norm; or, where its nu- source’’ of the nutrient, such as ‘‘only trient value is representative of the 200 milligrams (mg) sodium per serv- product type, a market leader. Firms ing, not a low sodium product.’’ The using such a reference nutrient value disclaimer must be in easily legible as a basis for a claim, are required to print or type and in a size no less than provide specific information upon required by § 381.121(c) for the net quan- which the nutrient value was derived, tity of contents, except where the size on request, to consumers and appro- of the claim is less than two times the priate regulatory officials. required size of the net quantity of (B) For relative claims other than contents statement, in which case the ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ disclaimer statement shall be no less claims, the reference product may be than one-half the size of the claim but the same as that provided for ‘‘light’’ no smaller than 1⁄16-inch minimum in paragraph (j)(1)(ii)(A) of this section height, except as permitted by or it may be the manufacturer’s regu- § 381.500(d)(2); lar product, or that of another manu- (3) The statement does not in any facturer, that has been offered for sale way implicitly characterize the level of to the public on a regular basis for a the nutrient in the product and it is substantial period of time in the same not false or misleading in any respect geographic area by the same business

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entity or by one entitled to use its (D) A claim elsewhere on the label or trade name, provided the name of the labeling. competitor is not used on the labeling (iv) The label or labeling must also of the product. The nutrient values bear: used to determine the claim when com- (A) Clear and concise quantitative in- paring a single manufacturer’s product formation comparing the amount of to the labeled product shall be either the subject nutrient in the product per the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and vided that the resulting labeling is in- (B) This statement shall appear adja- ternally consistent (i.e., that the val- cent to the most prominent claim or to ues stated in the nutrition informa- the nutrition information. tion, the nutrient values in the accom- (3) A relative claim for decreased lev- panying information, and the declara- els of a nutrient may not be made on tion of the percentage of nutrient by the label or in labeling of a product if which the product has been modified the nutrient content of the reference are consistent and will not cause product meets the requirement for a consumer confusion when compared), ‘‘low’’ claim for that nutrient. and that the actual modification is at (k) The term ‘‘modified’’ may be used least equal to the percentage specified in the statement of identity of a prod- in the definition of the claim. uct that bears a relative claim that (2) For products bearing relative complies with the requirements of this claims: part, followed immediately by the (i) The label or labeling must state name of the nutrient whose content the identity of the reference product has been altered (e.g., ‘‘modified fat and the percent (or fraction) of the ‘product’ ’’). This statement of identity amount of the nutrient in the reference must be immediately followed by the product by which the nutrient has been comparative statement such as ‘‘con- modified, (e.g., ‘‘50 percent less fat tains 35 percent less fat than ‘reference than ‘reference product’ ’’ or ‘‘1⁄3 fewer product’.’’ The label or labeling must calories than ‘reference product’ ’’); and also bear the information required by (ii) This information shall be imme- paragraph (j)(2) of this section in the diately adjacent to the most prominent manner prescribed. claim in easily legible boldface print or (l) For purposes of making a claim, a type, in distinct contrast to other ‘‘meal-type product’’ shall be defined printed or graphic matter, that is no as a product that: less than that required by § 381.121(c) (1) Makes a significant contribution for net quantity of contents, except to the diet by weighing at least 6 where the size of the claim is less than ounces, but no more than 12 ounces per two times the required size of the net serving (container), and quantity of contents statement, in (2) Contains ingredients from two or which case the referral statement shall more of the following four food groups: be no less than one-half the size of the (i) Bread, cereal, rice and pasta claim, but no smaller than 1⁄16-inch group, minimum height, except as permitted (ii) Fruits and vegetables group, by § 381.500(d)(2). (iii) Milk, yogurt, and cheese group, (iii) The determination of which use and of the claim is in the most prominent (iv) Meat, poultry, fish, dry beans, location on the label or labeling will be eggs, and nuts group, and made based on the following factors, (3) Is represented as, or is in a form considered in order: commonly understood to be a break- (A) A claim on the principal display fast, lunch, dinner, meal, main dish, panel adjacent to the statement of entree, or pizza. Such representations identity; may be made either by statements, (B) A claim elsewhere on the prin- photographs, or vignettes. cipal display panel; (m) [Reserved] (C) A claim on the information panel; (n) Nutrition labeling in accordance or with § 381.409 shall be provided for any

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food for which a nutrient content claim medical foods, as described in 21 CFR is made. 101.13(q)(4). (o) Compliance with requirements for (5) [Reserved] nutrient content claims shall be in ac- (6) Nutrient content claims that were cordance with § 381.409(h). part of the name of a product that was (p)(1) Unless otherwise specified, the subject to a standard of identity as of reference amount customarily November 27, 1991, are not subject to consumed set forth in § 381.412(b) the requirements of paragraph (b) of through (e) shall be used in determin- this section whether or not they meet ing whether a product meets the cri- the definition of the descriptive term. teria for a nutrient content claim. If (7) Implied nutrient content claims the serving size declared on the prod- may be used as part of a brand name, uct label differs from the reference amount customarily consumed, and the provided that the use of the claim has amount of the nutrient contained in been authorized by FSIS. Labeling ap- the labeled serving does not meet the plications requesting approval of such maximum or minimum amount cri- a claim may be submitted pursuant to terion in the definition for the § 381.469. descriptor for that nutrient, the claim [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, shall be followed by the criteria for the 1993, as amended at 58 FR 47628, Sept. 10, claim as required by § 381.412(f) (e.g., 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, ‘‘very low sodium, 35 mg or less per 55 Sept. 1, 1994; 60 FR 208, Jan. 3, 1995] grams’’). (2) The criteria for the claim shall be §§ 381.414–381.442 [Reserved] immediately adjacent to the most prominent claim in easily legible print § 381.443 Significant participation for or type and in a size that is no less voluntary nutrition labeling. than that required by § 381.121(c) for net (a) In evaluating significant partici- quantity of contents, except where the pation for voluntary nutrition labeling, size of the claim is less than two times FSIS will consider only the major cuts the required size of the net quantity of of single-ingredient, raw poultry prod- contents statement, in which case the ucts, as identified in § 381.444, including criteria statement shall be no less than those that have been previously frozen. one-half the size of the claim but no (b) FSIS will judge a food retailer to smaller than 1/16-inch minimum be participating at a significant level if height, except as permitted by the retailer provides nutrition labeling § 381.500(d)(2). information for at least 90 percent of (q) The following exemptions apply: the major cuts of single-ingredient, (1) Nutrient content claims that have raw poultry products, listed in § 381.444, not been defined by regulation and that that it sells, and if the nutrition label appear as part of a brand name that is consistent in content and format was in use prior to November 27, 1991, with the mandatory program, or nutri- may continue to be used as part of that tion information is displayed at point- brand name, provided they are not of-purchase in an appropriate manner. false or misleading under section 4(h) of the Act (21 U.S.C. 453(h)(4)). (c) To determine whether there is sig- (2) [Reserved] nificant participation by retailers (3) A statement that describes the under the voluntary nutrition labeling percentage of a vitamin or mineral in guidelines, FSIS will select a rep- the food, including foods intended spe- resentative sample of companies allo- cifically for use by infants and children cated by type and size. less than 2 years of age, in relation to (d) FSIS will find that significant a Reference Daily Intake (RDI) as de- participation by food retailers exists if fined in § 381.409 may be made on the at least 60 percent of all companies label or in the labeling of a food with- that are evaluated are participating in out a regulation authorizing such a accordance with the guidelines. claim for a specific vitamin or mineral. (e) FSIS will evaluate significant (4) The requirements of this section participation of the voluntary program do not apply to infant formulas and every 2 years beginning in May 1995.

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(1) If significant participation is (i) The requirements of the manda- found, the voluntary nutrition labeling tory nutrition labeling program apply, guidelines shall remain in effect. but the nutrition information may be (2) If significant participation is not supplied on an ‘‘as packaged’’ or ‘‘as found, FSIS shall initiate rulemaking consumed,’’ basis; to require nutrition labeling on those (ii) The listing of percent of Daily products under the voluntary program. Value for the nutrients (except vitamins and minerals specified in § 381.444 Identification of major cuts § 381.409(c)(8)) and footnote required by of poultry products. § 381.409(d)(9) may be omitted; and The major cuts of single-ingredient, (iii) The point-of-purchase materials raw poultry products are: Whole chick- are not subject to any of the format re- en (without neck and giblets), chicken quirements. breast, chicken wing, chicken drum- (b) [Reserved] stick, chicken thigh, whole turkey (c) The declaration of nutrition infor- (without necks and giblets; separate mation may be presented in a sim- nutrient panels for white and dark plified format as specified in § 381.409(f) meat permitted as an option), turkey for the mandatory nutrition labeling breast, turkey wing, turkey drumstick, program. and turkey thigh. (d) The nutrition label data should be § 381.445 Guidelines for voluntary nu- based on either raw or cooked edible trition labeling of single-ingredient, portions of poultry cuts with skin. If raw products. data are based on cooked portions, the (a) Nutrition information on the cuts methods used to cook the products of single-ingredient, raw poultry prod- must be specified and should be those ucts, including those that have been which do not add nutrients from other previously frozen, shall be provided in ingredients such as flour, breading, and the following manner: salt. Additional nutritional data may (1) If a retailer or manufacturer be presented on an optional basis for chooses to provide nutrition informa- the raw or cooked edible portions of tion on the label of these products, the skinless poultry meat. these products shall be subject to all (e) Nutrient data that are the most requirements of the mandatory nutri- current representative data base values tion labeling program, except that nu- contained in USDA’s National Nutrient trition labeling may be declared on the Data Bank or its published form, the basis of either ‘‘as consumed’’ or ‘‘as Agriculture Handbook No. 8 series, packaged.’’ In addition, the declaration may be used for nutrition labeling of of the number of servings per container single-ingredient, raw poultry prod- need not be included in nutrition label- ucts, including those that have been ing of single-ingredient, raw poultry previously frozen. These data may be products, including those that have composite data that reflect different been previously frozen. classes of turkey or other variables af- (2) A retailer may choose to provide fecting nutrient content. Alter- nutrition information at the point-of- natively, data that reflect specific purchase, such as by posting a sign, or classes or other variables may be used, by making the information readily except that if data are used on labels available in brochures, notebooks, or attached to a product which is labeled leaflet form in close proximity to the as to class of poultry or other vari- food. The nutrition labeling informa- ables, the data must represent the tion may also be supplemented by a product in the package when such data video, live demonstration, or other are contained in the representative media. If a nutrition claim is made on data base. When data are used on labels point-of-purchase materials all of the attached to a product, the data must requirements of the mandatory nutri- represent the edible poultry tissues tion labeling program apply. However, present in the package. if only nutrition information—and not (f) If the nutrition information is in a nutrition claim—is supplied on point- accordance with paragraph (e) of this of-purchase materials: section, a nutrition label or labeling

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will not be subject to the Agency com- claim (e.g., ‘‘the serving of broccoli in pliance review under § 381.409(h), unless this meal is high in vitamin C’’). a nutrition claim is made on the basis (c) ‘‘Good Source’’ claims. (1) The of the representative data base values. terms ‘‘good source,’’ ‘‘contains,’’ or (g) Retailers may use data bases that ‘‘provides’’ may be used on the label or they believe reflect the nutrient con- in labeling of products, except meal- tent of single-ingredient, raw poultry type products as described in products, including those that have § 381.413(l), provided that the product been previously frozen; however, such contains 10 to 19 percent of the RDI or labeling shall be subject to the compli- the DRV per reference amount cus- ance procedures of paragraph (e) of this tomarily consumed. section and the requirements specified (2) The terms defined in paragraph in this Subpart for the mandatory nu- (c)(1) of this section may be used on the trition labeling program. label or in labeling of a meal-type [58 FR 675, Jan. 6, 1993, as amended at 58 FR product as defined in § 381.413(l), pro- 47628, Sept. 10, 1993; 60 FR 209, Jan. 3, 1995] vided that: (i) The product contains a food that §§ 381.446–381.453 [Reserved] meets the definition of ‘‘good source’’ in paragraph (c)(1) of this section; and § 381.454 Nutrient content claims for ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ (ii) The label or labeling clearly identifies the food that is the subject of the (a) General requirements. Except as claim (e.g., ‘‘the serving of sweet pota- provided in paragraph (e) of this sec- toes in this meal is a good source of tion, a claim about the level of a nutri- fiber’’). ent in a product in relation to the Ref- erence Daily Intake (RDI) or Daily Ref- (d) Fiber claims. (1) If a nutrient con- erence Value (DRV), established for tent claim is made with respect to the that nutrient (excluding total carbo- level of dietary fiber, i.e., that the hydrate) in § 381.409(c), may only be product is high in fiber, a good source made on the label or in labeling of the of fiber, or that the product contains product if: ‘‘more’’ fiber, and the product is not (1) The claim uses one of the terms ‘‘low’’ in total fat as defined in defined in this section in accordance § 381.462(b)(2) or, in the case of a meal- with the definition for that term; type product, is not ‘‘low’’ in total fat (2) The claim is made in accordance as defined in § 381.462(b)(3), then the la- with the general requirements for nu- beling shall disclose the level of total trient content claims in § 381.413; and fat per labeled serving size (e.g., ‘‘con- (3) The product for which the claim is tains 12 grams (g) of fat per serving’’); made is labeled in accordance with and § 381.409. (2) The disclosure shall appear in im- (b) ‘‘High’’ claims. (1) The terms mediate proximity to such claim and ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source be in a type size no less than one-half of’’ may be used on the label or in la- the size of the claim. beling of products, except meal-type (e) ‘‘More’’ claims. (1) A relative claim products as defined in § 381.413(l), pro- using the terms ‘‘more’’ and ‘‘added’’ vided that the product contains 20 per- may be used on the label or in labeling cent or more of the RDI or the DRV per to describe the level of protein, vita- reference amount customarily mins, minerals, dietary fiber, or potas- consumed. sium in a product, except meal-type (2) The terms defined in paragraph products as defined in § 381.413(l), pro- (b)(1) of this section may be used on vided that: the label or in labeling of a meal-type (i) The product contains at least 10 product as defined in § 381.413(l), pro- percent more of the RDI or the DRV vided that: for protein, vitamins, minerals, dietary (i) The product contains a food that fiber, or potassium (expressed as a per- meets the definition of ‘‘high’’ in para- cent of the Daily Value) per reference graph (b)(1) of this section; and amount customarily consumed than an (ii) The label or labeling clearly iden- appropriate reference product as de- tifies the food that is the subject of the scribed in § 381.413(j)(1); and

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(ii) As required in § 381.413(j)(2) for § 381.455 [Reserved] relative claims: (A) The identity of the reference § 381.456 Nutrient content claims for product and the percent (or fraction) ‘‘light’’ or ‘‘lite.’’ that the nutrient is greater relative to (a) General requirements. A claim the RDI or DRV are declared in imme- using the terms ‘‘light’’ or ‘‘lite’’ to de- diate proximity to the most prominent scribe a product may only be made on such claim (e.g., ‘‘contains 10 percent the label or in labeling of the product more of the Daily Value for fiber than if: ‘reference product’ ’’); and (1) The claim uses one of the terms (B) Quantitative information com- defined in this section in accordance paring the level of the nutrient in the with the definition for that term; product per labeled serving size with (2) The claim is made in accordance that of the reference product that it re- with the general requirements for nu- places is declared adjacent to the most trient content claims in § 381.413; and prominent claim or to the nutrition in- (3) The product for which the claim is formation (e.g., ‘‘fiber content of ‘ref- made is labeled in accordance with § 381.409. erence product’ is 1 g per serving; ‘this product’ contains 4 g per serving’’). (b) ‘‘Light’’ claims. The terms ‘‘light’’ or ‘‘lite’’ may be used on the label or in (2) A relative claim using the terms labeling of products, except meal-type ‘‘more’’ and ‘‘added’’ may be used on products as defined in § 381.413(l), with- the label or in labeling to describe the out further qualification, provided level of protein, vitamins, minerals, di- that: etary fiber, or potassium in meal-type (1) If the product derives 50 percent products as defined in § 381.413(l), pro- or more of its calories from fat, its fat vided that: content is reduced by 50 percent or (i) The product contains at least 10 more per reference amount customar- percent more of the RDI or the DRV ily consumed compared to an appro- for protein, vitamins, minerals, dietary priate reference product as described in fiber, or potassium (expressed as a per- § 381.413(j)(1); or cent of the Daily Value) per 100 g of (2) If the product derives less than 50 product than an appropriate reference percent of its calories from fat: product as described in § 381.413(j)(1); (i) The number of calories is reduced and by at least one-third (331⁄3 percent) per (ii) As required in § 381.413(j)(2) for reference amount customarily relative claims: consumed compared to an appropriate (A) The identity of the reference reference product as described in product and the percent (or fraction) § 381.413(j)(1); or that the nutrient is greater relative to (ii) Its fat content is reduced by 50 the RDI or DRV are declared in imme- percent or more per reference amount diate proximity to the most prominent customarily consumed compared to the such claim (e.g., ‘‘contains 10 percent appropriate reference product as de- more of the Daily Value for fiber per 3 scribed in § 381.413(j)(1); and ounces (oz) than does ‘reference prod- (3) As required in § 381.413(j)(2) for rel- uct’ ’’), and ative claims: (B) Quantitative information com- (i) The identity of the reference prod- paring the level of the nutrient in the uct and the percent (or fraction) that the calories and the fat were reduced meal-type product per specified weight are declared in immediate proximity to with that of the reference product that the most prominent such claim (e.g., it replaces is declared adjacent to the ‘‘1⁄3 fewer calories and 50 percent less most prominent claim or to the nutri- fat than the market leader’’); and tion information (e.g., ‘‘fiber content of (ii) Quantitative information com- ‘reference product’ is 2 g per 3 oz; ‘this paring the level of calories and fat con- product’ contains 5 g per 3 oz’’). tent in the product per labeled serving [60 FR 210, Jan. 3, 1995] size with that of the reference product that it replaces is declared adjacent to

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the most prominent claim or to the nu- most prominent such claim (e.g., ‘‘50 trition information (e.g., ‘‘lite ‘this percent less sodium than the market product’—200 calories, 4 grams (g) fat; leader’’); and regular ‘reference product’—300 cal- (B) Quantitative information com- ories, 8 g fat per serving’’); and paring the level of sodium per labeled (iii) If the labeled product contains serving size with that of the reference less than 40 calories or less than 3 g fat product it replaces is declared adjacent per reference amount customarily to the most prominent claim or to the consumed, the percentage reduction for nutrition information (e.g., or ‘‘lite that nutrient need not be declared. ‘this product’—170 mg sodium per serv- (4) A ‘‘light’’ claim may not be made ing; regular ‘reference product’—350 mg on a product for which the reference per serving’’). product meets the definition of ‘‘low (3) Except for meal-type products as fat’’ and ‘‘low calorie.’’ defined in § 381.413(l), a ‘‘light in so- (c)(1)(i) A product for which the ref- dium’’ claim may not be made on a erence product contains 40 calories or product for which the reference prod- less and 3 g fat or less per reference uct meets the definition of ‘‘low in so- amount customarily consumed may dium.’’ use the terms ‘‘light’’ or ‘‘lite’’ without (d)(1) The terms ‘‘light’’ or ‘‘lite’’ further qualification if it is reduced by may be used on the label or in labeling 50 percent or more in sodium content of a meal-type product as defined in compared to the reference product; and § 381.413(l), provided that: (ii) As required in § 381.413(j)(2) for (i) The product meets the definition relative claims: of: (A) The identity of the reference (A) ‘‘Low in calories’’ as defined in product and the percent (or fraction) § 381.460(b)(3); or that the sodium was reduced are de- (B) ‘‘Low in fat’’ as defined in clared in immediate proximity to the § 381.462(b)(3); and most prominent such claim (e.g., ‘‘50 (ii)(A) A statement appears on the percent less sodium than the market principal display panel that explains leader’’); and whether ‘‘light’’ is used to mean ‘‘low (B) Quantitative information com- fat,’’ ‘‘low calories,’’ or both (e.g., paring the level of sodium per labeled ‘‘Light Delight, a low fat meal’’); and serving size with that of the reference product it replaces is declared adjacent (B) The accompanying statement is to the most prominent claim or to the no less than one-half the type size of nutrition information (e.g., ‘‘lite ‘this the ‘‘light’’ or ‘‘lite’’ claim. product’—500 milligrams (mg) sodium (2)(i) The terms ‘‘light in sodium’’ or per serving; regular ‘reference prod- ‘‘lite in sodium’’ may be used on the uct’—1,000 mg sodium per serving’’). label or in labeling of a meal-type (2)(i) A product for which the ref- product as defined in § 381.413(l), pro- erence product contains more than 40 vided that the product meets the defi- calories or more than 3 g fat per ref- nition of ‘‘low in sodium’’ as defined in erence amount customarily consumed § 381.461(b)(5)(i); and may use the terms ‘‘light in sodium’’ (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- or ‘‘lite in sodium’’ if it is reduced by dium’’ are presented in uniform type 50 percent or more in sodium content size, style, color, and prominence. compared to the reference product, pro- (3) The terms ‘‘light’’ or ‘‘lite’’ may vided that ‘‘light’’ or ‘‘lite’’ is pre- be used in the brand name of a product sented in immediate proximity with to describe the sodium content, pro- ‘‘in sodium’’ and the entire term is pre- vided that: sented in uniform type size, style, (i) The product is reduced by 50 per- color, and prominence; and cent or more in sodium content com- (ii) As required in § 381.413(j)(2) for pared to the reference product; relative claims: (ii) A statement specifically stating (A) The identity of the reference that the product is ‘‘light in sodium’’ product and the percent (or fraction) or ‘‘lite in sodium’’ appears: that the sodium was reduced are de- (A) Contiguous to the brand name; clared in immediate proximity to the and

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(B) In uniform type size, style, color, the label or labeling as specified in and prominence as the product name; § 381.413(j)(2). and [60 FR 210, Jan. 3, 1995] (iii) As required in § 381.413(j)(2) for relative claims: §§ 381.457–381.459 [Reserved] (A) The identity of the reference product and the percent (or fraction) § 381.460 Nutrient content claims for calorie content. that the sodium was reduced are declared in immediate proximity to the (a) General requirements. A claim most prominent such claim; and about the calorie or sugar content of a (B) Quantitative information com- product may only be made on the label paring the level of sodium per labeled or in labeling of the product if: (1) The claim uses one of the terms serving size with that of the reference defined in this section in accordance product it replaces is declared adjacent with the definition for that term; to the most prominent claim or to the (2) The claim is made in accordance nutrition information. with the general requirements for nu- (e) Except as provided in paragraphs trient content claims in § 381.413; and (b) through (d) of this section, the (3) The product for which the claim is terms ‘‘light’’ or ‘‘lite’’ may not be made is labeled in accordance with used to refer to a product that is not § 381.409. reduced in fat by 50 percent, or, if ap- (b) Calorie content claims. (1) The plicable, in calories by 1⁄3 or, when terms ‘‘calorie free,’’ ‘‘free of calories,’’ properly qualified, in sodium by 50 per- ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- cent unless: out calories,’’ ‘‘trivial source of cal- (1) It describes some physical or ories,’’ ‘‘negligible source of calories,’’ organoleptic attribute of the product or ‘‘dietarily insignificant source of such as texture or color and the infor- calories’’ may be used on the label or mation (e.g., ‘‘light in color’’ or ‘‘light in labeling of products, provided that: in texture’’) so stated, clearly conveys (i) The product contains less than 5 the nature of the product; and calories per reference amount cus- (2) The attribute (e.g., ‘‘color’’ or tomarily consumed and per labeled ‘‘texture’’) is in the same style, color, serving size; and and at least one-half the type size as (ii) If the product meets this condi- the word ‘‘light’’ and in immediate tion without the benefit of special proximity thereto. processing, alteration, formulation, or (f) If a manufacturer can dem- reformulation to lower the caloric content, it is labeled to clearly refer to all onstrate that the word ‘‘light’’ has products of its type and not merely to been associated, through common use, the particular brand to which the label with a particular product to reflect a attaches. physical or organoleptic attribute to (2) The terms ‘‘low calorie,’’ ‘‘few cal- the point where it has become part of ories,’’ ‘‘contains a small amount of the statement of identity, such use of calories,’’ ‘‘low source of calories,’’ or the term ‘‘light’’ shall not be consid- ‘‘low in calories’’ may be used on the ered a nutrient content claim subject label or in labeling of products, except to the requirements in this part. meal-type products as defined in (g) The term ‘‘lightly salted’’ may be § 381.413(l), provided that: used on a product to which has been (i)(A) The product has a reference added 50 percent less sodium than is amount customarily consumed greater normally added to the reference prod- than 30 grams (g) or greater than 2 ta- uct as described in § 381.413(j)(1)(i)(B) blespoons (tbsp) and does not provide and (j)(1)(ii)(B), provided that if the more than 40 calories per reference product is not ‘‘low in sodium’’ as de- amount customarily consumed; or fined in § 381.461(b)(4), the statement (B) The product has a reference ‘‘not a low sodium food,’’ shall appear amount customarily consumed of 30 g adjacent to the nutrition information or less or 2 tbsp or less and does not and the information required to accom- provide more than 40 calories per ref- pany a relative claim shall appear on erence amount customarily consumed

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and per 50 g (for dehydrated products nent claim or to the nutrition informa- that must be reconstituted before typi- tion (e.g., ‘‘calorie content has been re- cal consumption with water or a dilu- duced from 150 to 100 calories per serv- ent containing an insignificant ing’’). amount, as defined in § 381.409(f)(1), of (iii) Claims described in paragraph all nutrients per reference amount cus- (b)(4) of this section may not be made tomarily consumed, the per-50-g cri- on the label or in labeling of products terion refers to the ‘‘as prepared’’ if the reference product meets the defi- form). nition for ‘‘low calorie.’’ (ii) If the product meets these condi- (5) The terms defined in paragraph tions without the benefit of special (b)(4) of this section may be used on processing, alteration, formulation, or the label or in labeling of a meal-type reformulation to lower the caloric con- product as defined in § 381.413(l), pro- tent, it is labeled to clearly refer to all vided that: products of its type and not merely to (i) The product contains at least 25 the particular brand to which the label percent fewer calories per 100 g of prod- attaches. uct than an appropriate reference prod- (3) The terms defined in paragraph uct as described in § 381.413(j)(1); and (b)(2) of this section may be used on (ii) As required in § 381.413(j)(2) for the label or in labeling of a meal-type relative claims: product as defined in § 381.413(l), pro- (A) The identity of the reference vided that: product and the percent (or fraction) (i) The product contains 120 calories that the calories differ between the two or less per 100 g of product; and products are declared in immediate (ii) If the product meets this condi- proximity to the most prominent such tion without the benefit of special claim (e.g., ‘‘calorie reduced ‘product’, processing, alteration, formulation, or 25% less calories per ounce (oz) (or 3 oz) reformulation to lower the calorie con- than our regular ‘product’ ’’); and tent, it is labeled to clearly refer to all (B) Quantitative information com- products of its type and not merely to paring the level of calories in the prod- the particular brand to which it at- uct per specified weight with that of taches. the reference product that it replaces (4) The terms ‘‘reduced calorie,’’ ‘‘re- is declared adjacent to the most promi- duced in calories,’’ ‘‘calorie reduced,’’ nent claim or to the nutrition informa- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or tion (e.g., ‘‘calorie content has been re- ‘‘lower in calories’’ may be used on the duced from 110 calories per 3 oz to 80 label or in labeling of products, except calories per 3 oz’’). meal-type products as defined in (iii) Claims described in paragraph § 381.413(l), provided that: (b)(5) of this section may not be made (i) The product contains at least 25 on the label or in labeling of products percent fewer calories per reference if the reference product meets the defi- amount customarily consumed than an nition for ‘‘low calorie.’’ appropriate reference product as de- (c) Sugar content claims. (1) Terms scribed in § 381.413(j)(1); and such as ‘‘sugar free,’’ ‘‘free of sugar,’’ (ii) As required in § 381.413(j)(2) for ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without relative claims: sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of (A) The identity of the reference sugar,’’ ‘‘negligible source of sugar,’’ or product and the percent (or fraction) ‘‘dietarily insignificant source of that the calories differ between the two sugar’’ may reasonably be expected to products are declared in immediate be regarded by consumers as terms proximity to the most prominent such that represent that the product con- claim (e.g., lower calorie ‘product’—‘‘33 tains no sugars or sweeteners, e.g., 1⁄3 percent fewer calories than our regu- ‘‘sugar free,’’ or ‘‘no sugar,’’ as indicat- lar ‘product’ ’’); and ing a product which is low in calories (B) Quantitative information com- or significantly reduced in calories. paring the level of calories in the prod- Consequently, except as provided in uct per labeled serving size with that of paragraph (c)(2) of this section, a prod- the reference product that it replaces uct may not be labeled with such terms is declared adjacent to the most promi- unless:

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(i) The product contains less than 0.5 trition panel for further information g of sugars, as defined in on sugar and calorie content. § 381.409(c)(6)(ii), per reference amount (3) Paragraph (c)(1) of this section customarily consumed and per labeled shall not apply to a factual statement serving size or, in the case of a meal- that a product, including products in- type product, less than 0.5 g of sugars tended specifically for infants and chil- per labeled serving size; dren less than 2 years of age, is un- (ii) The product contains no ingredi- sweetened or contains no added sweet- ent that is a sugar or that is generally eners in the case of a product that con- understood by consumers to contain tains apparent substantial inherent sugars unless the listing of the ingredi- sugar content, e.g., juices. ent in the ingredients statement is fol- (4) The terms ‘‘reduced sugar,’’ ‘‘re- lowed by an asterisk that refers to the duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less statement below the list of ingredients, sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in which states: ‘‘Adds a trivial amount of sugar’’ may be used on the label or in sugar,’’ ‘‘adds a negligible amount of labeling of products, except meal-type sugar,’’ or ‘‘adds a dietarily insignifi- products as defined in § 381.413(l), pro- cant amount of sugar;’’ and vided that: (iii)(A) It is labeled ‘‘low calorie’’ or (i) The product contains at least 25 ‘‘reduced calorie’’ or bears a relative percent less sugars per reference claim of special dietary usefulness la- amount customarily consumed than an beled in compliance with paragraphs appropriate reference product as de- (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- scribed in § 381.413(j)(1); and tion; or (ii) As required in § 381.413(j)(2) for relative claims: (B) Such term is immediately accom- (A) The identity of the reference panied, each time it is used, by either product and the percent (or fraction) the statement ‘‘not a reduced calorie that the sugars differ between the two product,’’ ‘‘not a low calorie product,’’ products are declared in immediate or ‘‘not for weight control.’’ proximity to the most prominent such (2) The terms ‘‘no added sugar,’’ claim (e.g., ‘‘this product contains 25 ‘‘without added sugar,’’ or ‘‘no sugar percent less sugar than our regular added’’ may be used only if: product’’); and (i) No amount of sugars, as defined in (B) Quantitative information com- § 381.409(c)(6)(ii), or any other ingredi- paring the level of the sugar in the ent that contains sugars that function- product per labeled serving size with ally substitute for added sugars is that of the reference product that it re- added during processing or packaging; places is declared adjacent to the most (ii) The product does not contain an prominent claim or to the nutrition in- ingredient containing added sugars formation (e.g., ‘‘sugar content has such as jam, jelly, or concentrated been lowered from 8 g to 6 g per serv- fruit juice; ing’’). (iii) The sugars content has not been (5) The terms defined in paragraph increased above the amount present in (c)(4) of this section may be used on the the ingredients by some means such as label or in labeling of a meal-type the use of enzymes, except where the product as defined in § 381.413(l), pro- intended functional effect of the proc- vided that: ess is not to increase the sugars con- (i) The product contains at least 25 tent of a product, and a functionally percent less sugars per 100 g of product insignificant increase in sugars results; than an appropriate reference product (iv) The product that it resembles as described in § 381.413(j)(1); and and for which it substitutes normally (ii) As required in § 381.413(j)(2) for contains added sugars; and relative claims: (v) The product bears a statement (A) The identity of the reference that the product is not ‘‘low calorie’’ product and the percent (or fraction) or ‘‘calorie reduced’’ (unless the prod- that the sugars differ between the two uct meets the requirements for a ‘‘low’’ products are declared in immediate or ‘‘reduced calorie’’ product) and that proximity to the most prominent such directs consumers’ attention to the nu- claim (e.g., ‘‘reduced sugar ‘product’—

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25% less sugar than our regular ‘prod- the particular brand to which the label uct’ ’’); and attaches. (B) Quantitative information com- (2) The terms ‘‘very low sodium’’ or paring the level of the nutrient in the ‘‘very low in sodium’’ may be used on product per specified weight with that the label or in labeling of products, ex- of the reference product that it re- cept meal-type products as defined in places is declared adjacent to the most § 381.413(l), provided that: prominent claim or to the nutrition in- (i)(A) The product has a reference formation (e.g., ‘‘sugar content has amount customarily consumed greater been reduced from 17 g per 3 oz to 13 g than 30 grams (g) or greater than 2 ta- per 3 oz’’). blespoons (tbsp) and contains 35 mg or [60 FR 211, Jan. 3, 1995] less sodium per reference amount customarily consumed; or § 381.461 Nutrient content claims for (B) The product has a reference the sodium content. amount customarily consumed of 30 g (a) General requirements. A claim or less or 2 tbsp or less and contains 35 about the level of sodium in a product mg or less sodium per reference may only be made on the label or in la- amount customarily consumed and per beling of the product if: 50 g (for dehydrated products that must (1) The claim uses one of the terms be reconstituted before typical con- defined in this section in accordance sumption with water or a diluent con- with the definition for that term; taining an insignificant amount, as de- (2) The claim is made in accordance fined in § 381.409(f)(1), of all nutrients with the general requirements for nu- per reference amount customarily trient content claims in § 381.413; and consumed, the per-50-g criterion refers (3) The product for which the claim is to the ‘‘as prepared’’ form); and made is labeled in accordance with (ii) If the product meets these condi- § 381.409. tions without the benefit of special (b) Sodium content claims. (1) The processing, alteration, formulation, or terms ‘‘sodium free,’’ ‘‘free of sodium,’’ reformulation to lower the sodium con- ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without tent, it is labeled to clearly refer to all sodium,’’ ‘‘trivial source of sodium,’’ products of its type and not merely to ‘‘negligible source of sodium,’’ or the particular brand to which the label ‘‘dietarily insignificant source of so- attaches. dium’’ may be used on the label or in (3) The terms defined in paragraph labeling of products, provided that: (b)(2) of this section may be used on (i) The product contains less than 5 the label or in labeling of a meal-type milligrams (mg) of sodium per ref- product as defined in §381.413(l), pro- erence amount customarily consumed vided that: and per labeled serving size or, in the (i) The product contains 35 mg or less case of a meal-type product, less than 5 of sodium per 100 g of product; and mg of sodium per labeled serving size; (ii) If the product meets this condi- (ii) The product contains no ingredi- tion without the benefit of special ent that is sodium chloride or is gen- processing, alteration, formulation, or erally understood by consumers to con- reformulation to lower the sodium contain sodium unless the listing of the intent, it is labeled to clearly refer to all gredient in the ingredients statement products of its type and not merely to is followed by an asterisk that refers to the particular brand to which the label the statement below the list of ingredi- attaches. ents, which states: ‘‘Adds a trivial (4) The terms ‘‘low sodium,’’ ‘‘low in amount of sodium,’’ ‘‘adds a negligible sodium,’’ ‘‘little sodium,’’ ‘‘contains a amount of sodium’’ or ‘‘adds a dietarily small amount of sodium,’’ or ‘‘low insignificant amount of sodium;’’ and source of sodium’’ may be used on the (iii) If the product meets these condi- label and in labeling of products, ex- tions without the benefit of special cept meal-type products as defined in processing, alteration, formulation, or §381.413(l), provided that: reformulation to lower the sodium con- (i)(A) The product has a reference tent, it is labeled to clearly refer to all amount customarily consumed greater products of its type and not merely to than 30 g or greater than 2 tbsp and

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contains 140 mg or less sodium per ref- ‘product’, 50 percent less sodium than erence amount customarily consumed; regular ‘product’ ’’); and or (B) Quantitative information com- (B) The product has a reference paring the level of sodium in the prod- amount customarily consumed of 30 g uct per labeled serving size with that of or less or 2 tbsp or less and contains 140 the reference product that it replaces mg or less sodium per reference is declared adjacent to the most promi- amount customarily consumed and per nent claim or to the nutrition informa- 50 g (for dehydrated products that must tion (e.g., ‘‘sodium content has been be reconstituted before typical con- lowered from 300 to 150 mg per serv- sumption with water or a diluent con- ing’’). taining an insignificant amount, as de- (iii) Claims described in paragraph fined in §381.409(f)(1), of all nutrients (b)(6) of this section may not be made per reference amount customarily on the label or in labeling of a product consumed, the per-50-g criterion refers if the nutrient content of the reference to the ‘‘as prepared’’ form); and product meets the definition for ‘‘low (ii) If the product meets these condi- sodium.’’ tions without the benefit of special (7) The terms defined in paragraph processing, alteration, formulation, or (b)(6) of this section may be used on reformulation to lower the sodium con- the label or in labeling of a meal-type tent, it is labeled to clearly refer to all product as defined in § 381.413(l), pro- products of its type and not merely to vided that: the particular brand to which the label (i) The product contains at least 25 attaches. percent less sodium per 100 g of product (5) The terms defined in paragraph than an appropriate reference product (b)(4) of this section may be used on as described in § 381.413(j)(l); and the label or in labeling of a meal-type (ii) As required in § 381.413(j)(2) for product as defined in § 381.413(l), pro- relative claims: vided that: (A) The identity of the reference (i) The product contains 140 mg or product and the percent (or fraction) less sodium per 100 g of product; and that the sodium differs between the (ii) If the product meets these condi- two products are declared in imme- tions without the benefit of special diate proximity to the most prominent processing, alteration, formulation, or such claim (e.g., ‘‘reduced sodium reformulation to lower the sodium con- ‘product’—30% less sodium per 3 oz tent, it is labeled to clearly refer to all than our ‘regular product’ ’’); and products of its type and not merely to (B) Quantitative information com- the particular brand to which the label paring the level of sodium in the prod- attaches. uct per specified weight with that of (6) The terms ‘‘reduced sodium,’’ ‘‘re- the reference product that it replaces duced in sodium,’’ ‘‘sodium reduced,’’ is declared adjacent to the most promi- ‘‘less sodium,’’ ‘‘lower sodium,’’ or nent claim or to the nutrition informa- ‘‘lower in sodium’’ may be used on the tion (e.g., ‘‘sodium content has been relabel or in labeling of products, except duced from 220 mg per 3 oz to 150 mg meal-type products as defined in per 3 oz’’). § 381.413(l), provided that: (iii) Claims described in paragraph (i) The product contains at least 25 (b)(7) of this section may not be made percent less sodium per reference on the label or in labeling of products amount customarily consumed than an if the nutrient content of the reference appropriate reference product as de- product meets the definition for ‘‘low scribed in § 381.413(j)(l); and sodium.’’ (ii) As required in § 381.413(j)(2) for (c) The term ‘‘salt’’ is not synony- relative claims: mous with ‘‘sodium.’’ Salt refers to so- (A) The identity of the reference dium chloride. However, references to product and the percent (or fraction) salt content such as ‘‘unsalted,’’ ‘‘no that the sodium differs between the salt,’’ ‘‘no salt added’’ are potentially two products are declared in imme- misleading. diate proximity to the most prominent (1) The term ‘‘salt free’’ may be used such claim (e.g., ‘‘reduced sodium on the label or in labeling of products

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only if the product is ‘‘sodium free’’ as (ii) The product contains no added in- defined in paragraph (b)(1) of this sec- gredient that is a fat or is generally tion. understood by consumers to contain (2) The terms ‘‘unsalted,’’ ‘‘without fat unless the listing of the ingredient added salt,’’ and ‘‘no salt added’’ may in the ingredients statement is fol- be used on the label or in labeling of lowed by an asterisk that refers to the products only if: statement below the list of ingredients, (i) No salt is added during processing; which states: ‘‘Adds a trivial amount of (ii) The product that it resembles and fat,’’ ‘‘adds a negligible amount of fat,’’ for which it substitutes is normally or ‘‘adds a dietarily insignificant processed with salt; and amount of fat’’; and (iii) If the product is not sodium free, (iii) If the product meets these condi- the statement ‘‘not a sodium free prod- tions without the benefit of special uct’’ or ‘‘not for control of sodium in processing, alteration, formulation, or the diet’’ appears adjacent to the nutri- reformulation to lower the fat content, tion information of the product bearing it is labeled to clearly refer to all prod- the claim. ucts of its type and not merely to the (3) Paragraph (c)(2) of this section particular brand to which the label at- shall not apply to a factual statement taches. that a product intended specifically for (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ infants and children less than 2 years ‘‘contains a small amount of fat,’’ ‘‘low of age is unsalted, provided such state- source of fat,’’ or ‘‘little fat’’ may be ment refers to the taste of the product used on the label and in labeling of and is not false or otherwise mislead- products, except meal-type products as ing. defined in § 381.413(l), provided that: [60 FR 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, (i)(A) The product has a reference 1995] amount customarily consumed greater than 30 g or greater than 2 tablespoons § 381.462 Nutrient content claims for (tbsp) and contains 3 g or less of fat per fat, fatty acids, and cholesterol con- reference amount customarily tent. ′ consumed; or (a) General requirements. A claim (B) The product has a reference about the level of fat, fatty acid, and amount customarily consumed of 30 g cholesterol in a product may only be or less or 2 tbsp or less and contains 3 made on the label or in labeling of g or less of fat per reference amount products if: customarily consumed and per 50 g (for (1) The claim uses one of the terms dehydrated products that must be re- defined in this section in accordance constituted before typical consumption with the definition for that term; with water or a diluent containing an (2) The claim is made in accordance insignificant amount, as defined in with the general requirements for nu- § 381.409(f)(1), of all nutrients per ref- trient content claims in § 381.413; and erence amount customarily consumed, (3) The product for which the claim is the per-50-g criterion refers to the ‘‘as made is labeled in accordance with prepared’’ form). § 381.409. (ii) If the product meets these condi- (b) Fat content claims. (1) The terms tions without the benefit of special ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ processing, alteration, formulation, or ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ reformulation to lower the fat content, ‘‘trivial source of fat,’’ ‘‘negligible it is labeled to clearly refer to all prod- source of fat,’’ or ‘‘dietarily insignifi- ucts of its type and not merely to the cant source of fat’’ may be used on the particular brand to which the label at- label or in labeling of products, pro- taches. vided that: (3) The terms defined in paragraph (i) The product contains less than 0.5 (b)(2) of this section may be used on gram (g) of fat per reference amount the label or in labeling of a meal-type customarily consumed and per labeled product as defined in § 381.413(l), pro- serving size or, in the case of a meal- vided that: type product, less than 0.5 g of fat per (i) The product contains 3 g or less of labeled serving size; total fat per 100 g of product and not

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more than 30 percent of calories from products are declared in immediate fat; and proximity to the most prominent such (ii) If the product meets these condi- claim (e.g., ‘‘reduced fat ‘product’, 33 tions without the benefit of special percent less fat per 3 oz than our regu- processing, alteration, formulation, or lar ‘product’ ’’); and reformulation to lower the fat content, (B) Quantitative information com- it is labeled to clearly refer to all prod- paring the level of fat in the product ucts of its type and not merely to the per specified weight with that of the particular brand to which the label at- reference product that it replaces is de- taches. clared adjacent to the most prominent (4) The terms ‘‘reduced fat,’’ ‘‘re- such claim or to the nutrition informa- duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ tion (e.g., ‘‘fat content has been re- ‘‘lower fat,’’ or ‘‘lower in fat’’ may be duced from 8 g per 3 oz to 5 g per 3 oz’’). used on the label or in labeling of prod- (iii) Claims described in paragraph ucts, except meal-type products as de- (b)(5) of this section may not be made fined in § 381.413(l), provided that: on the label or in labeling of a product (i) The product contains at least 25 if the nutrient content of the reference percent less fat per reference amount product meets the definition for ‘‘low customarily consumed than an appro- fat.’’ priate reference product as described in (6) The term ‘‘llllll percent fat § 381.413(j)(1); and free’’ may be used on the label or in la- (ii) As required in § 381.413(j)(2) for beling of products, provided that: relative claims: (i) The product meets the criteria for (A) The identity of the reference ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of product and the percent (or fraction) this section; that the fat differs between the two (ii) The percent declared and the products are declared in immediate words ‘‘fat free’’ are in uniform type proximity to the most prominent such size; and claim (e.g., ‘‘reduced fat—50 percent (iii) A ‘‘100 percent fat free’’ claim less fat than our regular ‘product’ ’’); may be made only on products that and meet the criteria for ‘‘fat free’’ in para- (B) Quantitative information com- graph (b)(1) of this section, that con- paring the level of fat in the product tain less than 0.5 g of fat per 100 g, and per labeled serving size with that of the that contain no added fat. reference product that it replaces is de- (iv) A synonym for ‘‘lll percent clared adjacent to the most prominent fat free’’ is ‘‘lll percent lean.’’ claim or to the nutrition information (c) Fatty acid content claims. (1) The (e.g., ‘‘fat content has been reduced terms ‘‘saturated fat free,’’ ‘‘free of from 8 g to 4 g per serving’’). saturated fat,’’ ‘‘no saturated fat,’’ (iii) Claims described in paragraph ‘‘zero saturated fat,’’ ‘‘without satu- (b)(4) of this section may not be made rated fat,’’ ‘‘trivial source of saturated on the label or in labeling of a product fat,’’ ‘‘negligible source of saturated if the nutrient content of the reference fat,’’ or ‘‘dietarily insignificant source product meets the definition for ‘‘low of saturated fat’’ may be used on the fat.’’ label or in labeling of products, pro- (5) The terms defined in paragraph vided that: (b)(4) of this section may be used on (i) The product contains less than 0.5 the label or in labeling of a meal-type g of saturated fat and less than 0.5 g product as defined in § 381.413(l), pro- trans fatty acids per reference amount vided that: customarily consumed and per labeled (i) The product contains at least 25 serving size or, in the case of a meal- percent less fat per 100 g of product type product, less than 0.5 g of satu- than an appropriate reference product rated fat and less than 0.5 g trans fatty as described in § 381.413(j)(1); and acids per labeled serving size; (ii) As required in § 381.413(j)(2) for (ii) The product contains no ingredi- relative claims: ent that is generally understood by (A) The identity of the reference consumers to contain saturated fat un- product and the percent (or fraction) less the listing of the ingredient in the that the fat differs between the two ingredients statement is followed by an

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asterisk that refers to the statement meal-type products as defined in below the list of ingredients, which § 381.413(l), provided that: states: ‘‘Adds a trivial amount of satu- (i) The product contains at least 25 rated fat,’’ ‘‘adds a negligible amount percent less saturated fat per reference of saturated fat,’’ or ‘‘adds a dietarily amount customarily consumed than an insignificant amount of saturated fat;’’ appropriate reference product as de- and scribed in § 381.413(j)(1); and (iii) If the product meets these condi- (ii) As required in § 381.413(j)(2) for tions without the benefit of special relative claims: processing, alteration, formulation, or (A) The identity of the reference reformulation to lower saturated fat product and the percent (or fraction) content, it is labeled to clearly refer to that the saturated fat differs between all products of its type and not merely the two products are declared in imme- to the particular brand to which the diate proximity to the most prominent label attaches. such claim (e.g., ‘‘reduced saturated fat (2) The terms ‘‘low in saturated fat,’’ ‘product’, contains 50 percent less satu- ‘‘low saturated fat,’’ ‘‘contains a small rated fat than the national average for amount of saturated fat,’’ ‘‘low source ‘product’ ’’); and of saturated fat,’’ or ‘‘a little saturated (B) Quantitative information com- fat’’ may be used on the label or in la- paring the level of saturated fat in the beling of products, except meal-type product per labeled serving size with products as defined in § 381.413(l), pro- that of the reference product that it re- vided that: places is declared adjacent to the most (i) The product contains 1 g or less of prominent claim or to the nutrition in- saturated fat per reference amount cus- formation (e.g., ‘‘saturated fat reduced tomarily consumed and not more than from 3 g to 1.5 g per serving’’). 15 percent of calories from saturated (iii) Claims described in paragraph fat; and (c)(4) of this section may not be made (ii) If the product meets these condi- on the label or in labeling of a product tions without benefit of special proc- if the nutrient content of the reference essing, alteration, formulation, or re- product meets the definition for ‘‘low formulation to lower saturated fat con- saturated fat.’’ tent, it is labeled to clearly refer to all (5) The terms defined in paragraph products of its type and not merely to (c)(4) of this section may be used on the the particular brand to which the label label or in labeling of a meal-type attaches. product as defined in § 381.413(l), pro- (3) The terms defined in paragraph vided that: (c)(2) of this section may be used on the (i) The product contains at least 25 label or in labeling of a meal-type percent less saturated fat per 100 g of product as defined in § 381.413(l), pro- product than an appropriate reference vided that: product as described in § 381.413(j)(1); (i) The product contains 1 g or less of and saturated fat per 100 g and less than 10 (ii) As required in § 381.413(j)(2) for percent calories from saturated fat; relative claims: and (A) The identity of the reference (ii) If the product meets these condi- product and the percent (or fraction) tions without the benefit of special that the saturated fat differs between processing, alteration, formulation, or the two products are declared in imme- reformulation to lower saturated fat diate proximity to the most prominent content, it is labeled to clearly refer to such claim (e.g., ‘‘reduced saturated fat all products of its type and not merely ‘product’, 50 percent less saturated fat to the particular brand to which the than our regular ‘product’ ’’); and label attaches. (B) Quantitative information com- (4) The terms ‘‘reduced saturated paring the level of saturated fat in the fat,’’ ‘‘reduced in saturated fat,’’ ‘‘satu- product per specified weight with that rated fat reduced,’’ ‘‘less saturated of the reference product that it re- fat,’’ ‘‘lower saturated fat,’’ or ‘‘lower places is declared adjacent to the most in saturated fat’’ may be used on the prominent claim or to the nutrition in- label or in labeling of products, except formation (e.g., ‘‘saturated fat content

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has been reduced from 2.5 g per 3 oz to market share. As required in 1.5 g per 3 oz’’). § 381.413(j)(2) for relative claims: (iii) Claims described in paragraph (A) The identity of the reference (c)(5) of this section may not be made product and the percent (or fraction) on the label or in labeling of a product that the cholesterol was reduced are if the nutrient content of the reference declared in immediate proximity to the product meets the definition for ‘‘low most prominent such claim (e.g., ‘‘cho- saturated fat.’’ lesterol free ‘product’, contains 100 per- (d) Cholesterol content claims. (1) The cent less cholesterol than ‘reference terms ‘‘cholesterol free,’’ ‘‘free of cho- product’ ’’); and lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without (B) Quantitative information com- cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial paring the level of cholesterol in the source of cholesterol,’’ ‘‘negligible product per labeled serving size with source of cholesterol,’’ or ‘‘dietarily in- that of the reference product that it re- significant source of cholesterol’’ may places is declared adjacent to the most be used on the label or in labeling of prominent claim or to the nutrition in- products, provided that: formation (e.g., ‘‘contains no choles- (i) The product contains less than 2 terol compared with 30 mg in one serv- milligrams (mg) of cholesterol per ref- ing of ‘reference product’ ’’). erence amount customarily consumed (2) The terms ‘‘low in cholesterol,’’ and per labeled serving size or, in the ‘‘low cholesterol,’’ ‘‘contains a small case of a meal-type product as defined amount of cholesterol,’’ ‘‘low source of in § 381.413(l), less than 2 mg of choles- cholesterol,’’ or ‘‘little cholesterol’’ terol per labeled serving size; may be used on the label or in labeling (ii) The product contains no ingredi- of products, except meal-type products ent that is generally understood by as defined in § 381.413(l), provided that: consumers to contain cholesterol, un- (i)(A) If the product has a reference less the listing of the ingredient in the amount customarily consumed greater ingredients statement is followed by an than 30 g or greater than 2 tbsp: asterisk that refers to the statement below the list of ingredients, which (1) The product contains 20 mg or less states: ‘‘Adds a trivial amount of cho- of cholesterol per reference amount lesterol,’’ ‘‘adds a negligible amount of customarily consumed; and cholesterol,’’ or ‘‘adds a dietarily insig- (2) The product contains 2 g or less of nificant amount of cholesterol’’; saturated fat per reference amount cus- (iii) The product contains 2 g or less tomarily consumed; or of saturated fat per reference amount (B) If the product has a reference customarily consumed or, in the case amount customarily consumed of 30 g of a meal-type product as defined in or less or 2 tbsp or less: § 381.413(l), 2 g or less of saturated fat (1) The product contains 20 mg or less per labeled serving size; and of cholesterol per reference amount (iv) If the product meets these condi- customarily consumed and per 50 g (for tions without the benefit of special dehydrated products that must be reprocessing, alteration, formulation, or constituted before typical consumption reformulation to lower cholesterol con- with water or a diluent containing an tent, it is labeled to clearly refer to all insignificant amount, as defined in products of its type and not merely to § 381.409(f)(1), of all nutrients per ref- the particular brand to which it at- erence amount customarily consumed, taches; or the per-50-g criterion refers to the ‘‘as (v) If the product meets these condi- prepared’’ form); and tions only as a result of special proc- (2) The product contains 2 g or less of essing, alteration, formulation, or re- saturated fat per reference amount cus- formulation, the amount of cholesterol tomarily consumed. is reduced by 25 percent or more from (ii) If the product meets these condi- the reference product it replaces as de- tions without the benefit of special scribed in § 381.413(j)(1) and for which it processing, alteration, formulation, or substitutes as described in § 381.413(d) reformulation to lower cholesterol con- that has a significant (e.g., 5 percent or tent, it is labeled to clearly refer to all more of a national or regional market) products of its type and not merely to

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the particular brand to which the label (i) The product has been specifically attaches; or formulated, altered, or processed to re- (iii) If the product contains 20 mg or duce its cholesterol by 25 percent or less of cholesterol only as a result of more from the reference product it re- special processing, alteration, formula- places as described in § 381.413(j)(1) and tion, or reformulation, the amount of for which it substitutes as described in cholesterol is reduced by 25 percent or § 381.413(d) that has a significant (e.g., 5 more from the reference product it re- percent or more of a national or replaces as described in § 381.413(j)(1) and gional market) market share; for which it substitutes as described in (ii) The product contains 2 g or less § 381.413(d) that has a significant (e.g., 5 of saturated fat per reference amount percent or more of a national or re- customarily consumed; and gional market) market share. As re- (iii) As required in § 381.413(j)(2) for quired in § 381.413(j)(2) for relative relative claims: claims: (A) The identity of the reference (A) The identity of the reference product and the percent (or fraction) product and the percent (or fraction) that the cholesterol has been reduced that the cholesterol has been reduced are declared in immediate proximity to are declared in immediate proximity to the most prominent such claim (e.g., the most prominent such claim (e.g., ‘‘25 percent less cholesterol than ‘ref- ‘‘low cholesterol ‘product’, contains 85 erence product’ ’’); and percent less cholesterol than our regu- (B) Quantitative information com- lar ‘product’’’); and paring the level of cholesterol in the (B) Quantitative information com- product per labeled serving size with paring the level of cholesterol in the that of the reference product that it re- product per labeled serving size with places is declared adjacent to the most that of the reference product that it re- prominent claim or to the nutrition in- places is declared adjacent to the most formation (e.g., ‘‘cholesterol lowered prominent claim or to the nutrition in- from 55 mg to 30 mg per serving’’). formation (e.g., ‘‘cholesterol lowered (iv) Claims described in paragraph from 30 mg to 5 mg per serving’’). (d)(4) of this section may not be made (3) The terms defined in paragraph on the label or in labeling of a product (d)(2) of this section may be used on if the nutrient content of the reference the label or in labeling of a meal-type product meets the definition for ‘‘low product as defined in § 381.413(l), pro- cholesterol.’’ vided that: (5) The terms defined in paragraph (i) The product contains 20 mg or less (d)(4) of this section may be used on of cholesterol per 100 g of product; the label or in labeling of a meal-type (ii) The product contains 2 g or less product as defined in § 381.413(l), proof saturated fat per 100 g of product; vided that: and (i) The product has been specifically (iii) If the product meets these condi- formulated, altered, or processed to re- tions without the benefit of special duce its cholesterol by 25 percent or processing, alteration, formulation, or more from the reference product it re- reformulation to lower cholesterol con- places as described in § 381.413(j)(1) and tent, it is labeled to clearly refer to all for which it substitutes as described in products of its type and not merely to § 381.413(d) that has a significant (e.g., 5 the particular brand to which the label percent or more of a national or re- attaches. gional market) market share; (4) The terms ‘‘reduced cholesterol,’’ (ii) The product contains 2 g or less ‘‘reduced in cholesterol,’’ ‘‘cholesterol of saturated fat per 100 g of product; reduced,’’ ‘‘less cholesterol,’’ ‘‘lower and cholesterol,’’ or ‘‘lower in cholesterol’’ (iii) As required in § 381.413(j)(2) for may be used on the label or in labeling relative claims: of products or products that substitute (A) The identity of the reference for those products as specified in product and the percent (or fraction) § 381.413(d), excluding meal-type prod- that the cholesterol has been reduced ucts as defined in § 381.413(l), provided are declared in immediate proximity to that: the most prominent such claim (e.g.,

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‘‘25% less cholesterol than ‘reference lesterol per reference amount cus- product’ ’’); and tomarily consumed, per labeled serving (B) Quantitative information com- size, and, only for foods with reference paring the level of cholesterol in the amounts customarily consumed of 30 product per specified weight with that grams (g) or less or 2 tablespoons (tbsp) of the reference product that it re- or less, per 50 g, and, for dehydrated places is declared adjacent to the most products that must be reconstituted prominent claim or to the nutrition in- with water or a diluent containing an formation (e.g., ‘‘cholesterol content insignificant amount, as defined in has been reduced from 35 mg per 3 oz to § 381.409(f)(1), of all nutrients, the per- 25 mg per 3 oz). 50-g criterion refers to the prepared (iv) Claims described in paragraph form, except that: (d)(5) of this section may not be made (i) A meal-type product, as defined in on the label or in labeling of a product § 381.413(l), and including meal-type if the nutrient content of the reference products that weigh more than 12 product meets the definition for ‘‘low ounces (oz) per serving (container), cholesterol.’’ shall not contain more than 90 mg of (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. cholesterol per labeled serving size; (1) The term ‘‘lean’’ may be used on the and label or in labeling of a product, provided that the product contains less (ii) Single-ingredient, raw products than 10 g of fat, 4.5 g or less of satu- may meet the cholesterol criterion for rated fat, and less than 95 mg of choles- ‘‘extra lean’’ in § 381.462. terol per 100 g of product and per ref- (3) The product shall not contain erence amount customarily consumed more than 360 mg of sodium, except for individual foods, and per 100 g of that it shall not contain more than 480 product and per labeled serving size for mg of sodium during the first 24 meal-type products as defined in months of implementation, per ref- § 381.413(l). erence amount customarily consumed, (2) The term ‘‘extra lean’’ may be per labeled serving size, and, only for used on the label or in labeling of a foods with reference amounts cus- product, provided that the product con- tomarily consumed of 30 g or less or 2 tains less than 5 g of fat, less than 2 g tbsp or less, per 50 g, and, for dehy- of saturated fat, and less than 95 mg of drated products that must be reconsti- cholesterol per 100 g of product and per tuted with water or a diluent contain- reference amount customarily ing an insignificant amount, as defined consumed for individual foods, and per in § 381.409(f)(1), of all nutrients, the 100 g of product and per labeled serving per-50-g criterion refers to the prepared size for meal-type products as defined form, except that: in § 381.413(l). (i) A meal-type product, as defined in [60 FR 214, Jan. 3, 1995] § 381.413(l), and including meal-type products that weigh more than 12 oz § 381.463 Nutrient content claims for per serving (container), shall not con- ‘‘healthy.’’ tain more than 480 mg of sodium, ex- (a) The term ‘‘healthy,’’ or any other cept that it shall not contain more derivative of the term ‘‘health,’’ may than 600 mg of sodium during the first be used on the labeling of any poultry 24 months of implementation, per la- product, provided that the product is beled serving size; and labeled in accordance with § 381.409 and (ii) The requirements of this para- § 381.413. graph (b)(3) do not apply to single-in- (b)(1) The product shall meet the re- gredient, raw products. quirements for ‘‘low fat’’ and ‘‘low (4) The product shall contain 10 per- saturated fat,’’ as defined in § 381.462, cent or more of the Reference Daily In- except that single-ingredient, raw take or Daily Reference Value as de- products may meet the total fat and fined in § 381.409 for vitamin A, vitamin saturated fat criteria for ‘‘extra lean’’ C, iron, calcium, protein, or fiber per in § 381.462. reference amount customarily (2) The product shall not contain consumed prior to any nutrient addi- more than 60 milligrams (mg) of cho- tion, except that:

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(i) A meal-type product, as defined in formation may in whole or part be sub- § 381.413(l), and including meal-type ject to release to the public) in a writ- products that weigh at least 6 oz but ten statement signed by the person less than 10 oz per serving (container), who submitted it. Any reference to shall meet the level for two of the nu- published information should be ac- trients per labeled serving size; and companied by reprints or photostatic (ii) A meal-type product, as defined copies of such references. in § 381.413(l), and including meal-type (e) If nonclinical laboratory studies products that weigh 10 oz or more per accompany a labeling application, the serving (container), shall meet the applicant shall include, with respect to level for three of the nutrients per la- each nonclinical study included with beled serving size. the application, either a statement [59 FR 24228, May 10, 1994, as amended at 60 that the study has been, or will be, FR 217, Jan. 3, 1995] conducted in compliance with the good laboratory practice regulations as set §§ 381.464–381.468 [Reserved] forth in Part 58 of Chapter 1, Title 21, § 381.469 Labeling applications for nu- or, if any such study was not conducted trient content claims. in compliance with such regulations, a (a) This section pertains to labeling brief statement of the reason for the applications for claims, express or im- noncompliance. plied, that characterize the level of any (f) If clinical investigations accom- nutrient required to be on the label or pany a labeling application, the appli- in labeling of product by this subpart. cant shall include, with respect to each (b) Labeling applications included in clinical investigation included with the this section are: application, either a statement that (1) Labeling applications for a new the investigation was conducted in (heretofore unauthorized) nutrient con- compliance with the requirements for tent claim, institutional review set forth in Part 56 (2) Labeling applications for a syn- of Chapter 1, Title 21, or was not sub- onymous term (i.e., one that is consist- ject to such requirements in accord- ent with a term defined by regulation) ance with § 56.194 or § 56.105, and that it for characterizing the level of a nutri- was conducted in compliance with the ent, and requirements for informed consents set (3) Labeling applications for the use forth in Part 50 of Chapter 1, Title 21. of an implied claim in a brand name. (g) The availability for public disclo- (c) Labeling applications and sup- sure of labeling applications, along porting documentation to be filed with supporting documentation, sub- under this section shall be submitted mitted to the Agency under this sec- in quadruplicate, except that the sup- tion will be governed by the rules spec- porting documentation may be submit- ified in Subchapter D, Title 9. ted on a computer disc copy. If any (h) The data specified under this sec- part of the material submitted is in a tion to accompany a labeling applica- foreign language, it shall be accom- tion shall be submitted on separate panied by an accurate and complete English translation. The labeling appli- sheets, suitably identified. If such data cation shall state the applicant’s post has already been submitted with an office address. earlier labeling application from the (d) Pertinent information will be applicant, the present labeling applica- considered as part of an application on tion must provide the data. the basis of specific reference to such (i) The labeling application must be information submitted to and retained signed by the applicant or by his or her in the files of the Food Safety and In- attorney or agent, or (if a corporation) spection Service. However, any ref- by an authorized official. erence to unpublished information fur- (j) The labeling application shall in- nished by a person other than the ap- clude a statement signed by the person plicant will not be considered unless responsible for the labeling applica- use of such information is authorized tion, that to the best of his or her (with the understanding that such in- knowledge, it is a representative and

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balanced submission that includes un- available, the applicant shall submit the favorable information, as well as favor- assay method used, and data establishing the able information, known to him or her validity of the method for assaying the nu- pertinent to the evaluation of the la- trient in the particular food. The validation data shall include a statistical analysis of beling application. the analytical and product variability. (k)(1) Labeling applications for a new (iv) A detailed analysis of the potential ef- nutrient content claim shall be accom- fect of the use of the proposed claim on food panied by the following data which consumption, and any corresponding changes shall be submitted in the following in nutrient intake. The analysis shall spe- form to the Director, Food Labeling cifically address the intake of nutrients that Division, Regulatory Programs, Food have beneficial and negative consequences in Safety and Inspection Service, Wash- the total diet. If the claim is intended for a specific group within the population, the ington, DC 20250: above analysis shall specifically address the dietary practices of such group, and shall in- ———————————————————————— clude data sufficient to demonstrate that the (Date) dietary analysis is representative of such The undersigned, llllll submits this group. labeling application pursuant to 9 CFR Yours very truly, 381.469 with respect to (statement of the Applicant ——————————————— claim and its proposed use). Attached hereto, in quadruplicate, or on a By ——————————————————— computer disc copy, and constituting a part (Indicate authority) of this labeling application, are the follow- (2) Upon receipt of the labeling appli- ing: cation and supporting documentation, (i) A statement identifying the nutrient content claim and the nutrient that the the applicant shall be notified, in writ- term is intended to characterize with respect ing, of the date on which the labeling to the level of such nutrient. The statement application was received. Such notice shall address why the use of the term as pro- shall inform the applicant that the la- posed will not be misleading. The statement beling application is undergoing Agen- shall provide examples of the nutrient con- cy review and that the applicant shall tent claim as it will be used on labels or la- subsequently be notified of the Agen- beling, as well as the types of products on cy’s decision to consider for further re- which the claim will be used. The statement shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels the Agency shall notify the applicant, or labeling, as well as any factors that would in writing, that the labeling applica- make the use of the term inappropriate. tion is either being considered for fur- (ii) A detailed explanation supported by ther review or that it has been sum- any necessary data of why use of the food marily denied by the Administrator. component characterized by the claim is of importance in human nutrition by virtue of (4) If the labeling application is sum- its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to reasons therefor, including why the the public will derive from use of the claim Agency has determined that the pro- as proposed and why such benefit is not posed nutrient content claim is false or available through the use of existing terms misleading. The notification letter defined by regulation. If the claim is in- shall inform the applicant that the ap- tended for a specific group within the population, the analysis shall specifically address plicant may submit a written state- nutritional needs of such group, and sci- ment by way of answer to the notifica- entific data sufficient for such purpose, and tion, and that the applicant shall have data and information to the extent necessary the right to request a hearing with re- to demonstrate that consumers can be ex- spect to the merits or validity of the pected to understand the meaning of the Administrator’s decision to deny the term under the proposed conditions of use. use of the proposed nutrient content (iii) Analytical data that demonstrates the claim. amount of the nutrient that is present in the products for which the claim is intended. (i) If the applicant fails to accept the The assays should be performed on rep- determination of the Administrator resentative samples in accordance with and files an answer and requests a 381.409(h). If no USDA or AOAC methods are hearing, and the Administrator, after

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review of the answer, determines the spect to the merits or validity of the initial determination to be correct, the Administrator’s decision to deny the Administrator shall file with the Hear- use of the proposed nutrient content ing Clerk of the Department the notifi- claim. cation, answer, and the request for a (A) If the applicant fails to accept hearing, which shall constitute the the determination of the Adminis- complaint and answer in the proceed- trator and files an answer and requests ing, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall constitute the shall make the final determination for complaint and answer in the proceed- the Secretary. Any such determination ing, which shall thereafter be con- by the Secretary shall be conclusive ducted in accordance with the Depart- unless, within 30 days after receipt of ment’s Uniform Rules of Practice. notice of such final determination, the (B) The hearing shall be conducted applicant appeals to the United States before an administrative law judge Court of Appeals for the circuit in with the opportunity for appeal to the which the applicant has its principal Department’s Judicial Officer, who place of business or to the United shall make the final determination for States Court of Appeals for the District the Secretary. Any such determination of Columbia Circuit. by the Secretary shall be conclusive (5) If the labeling application is not unless, within 30 days after receipt of summarily denied by the Adminis- the notice of such final determination, trator, the Administrator shall publish the applicant appeals to the United in the FEDERAL REGISTER a proposed States Court of Appeals for the circuit rule to amend the regulations to au- in which the applicant has its principal thorize the use of the nutrient content place of business or to the United claim. The proposal shall also summa- States Court of Appeals for the District rize the labeling application, including of Columbia Circuit. where the supporting documentation (ii) If the claim is approved, the can be reviewed. The Administrator’s Agency shall notify the applicant, in proposed rule shall seek comment from writing, and shall also publish in the consumers, the industry, consumer and FEDERAL REGISTER a final rule amend- industry groups, and other interested ing the regulations to authorize the persons on the labeling application and use of the claim. the use of the proposed nutrient con- (l)(1) Labeling applications for a syn- tent claim. After public comment has onymous term shall be accompanied by been received and reviewed by the the following data which shall be sub- Agency, the Administrator shall make mitted in the following form to the Di- a determination on whether the pro- rector, Food Labeling Division, Regu- posed nutrient content claim shall be latory Programs, Food Safety and In- approved for use on the labeling of spection Service, Washington, DC 20250: poultry products. (i) If the claim is denied by the Ad- ———————————————————————— ministrator, the Agency shall notify (Date) the applicant, in writing, of the basis The undersigned, llllll submits this for the denial, including the reason labeling application pursuant to 9 CFR why the claim on the labeling was de- 381.469 with respect to (statement of the syn- termined by the Agency to be false or onymous term and its proposed use in a nu- misleading. The notification letter trient content claim that is consistent with shall also inform the applicant that the an existing term that has been defined under subpart Y of part 381). applicant may submit a written state- Attached hereto, in quadruplicate, or on a ment by way of answer to the notifica- computer disc copy, and constituting a part tion, and that the applicant shall have of this labeling application, are the follow- the right to request a hearing with re- ing:

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(i) A statement identifying the synony- leading. The notification letter shall mous term, the existing term defined by a inform the applicant that the applicant regulation with which the synonymous term may submit a written statement by is claimed to be consistent, and the nutrient that the term is intended to characterize the way of answer to the notification, and level of. The statement shall address why the that the applicant shall have the right use of the synonymous term as proposed will to request a hearing with respect to not be misleading. The statement shall pro- the merits or validity of the Adminis- vide examples of the nutrient content claim trator’s decision to deny the use of the as it will be used on labels or labeling, as proposed synonymous term. well as the types of products on which the claim will be used. The statement shall also (i) If the applicant fails to accept the specify whether any limitations not applica- determination of the Administrator ble to the use of the defined term are in- and files an answer and requests a tended to apply to the use of the synony- hearing, and the Administrator, after mous term. review of the answer, determines the (ii) A detailed explanation supported by initial determination to be correct, the any necessary data of why use of the proposed term is requested, including whether Administrator shall file with the Hear- the existing defined term is inadequate for ing Clerk of the Department the notifi- the purpose of effectively characterizing the cation, answer, and the request for a level of a nutrient. This explanation shall hearing, which shall constitute the also state what nutritional benefit to the complaint and answer in the proceed- public will derive from use of the claim as ing, which shall thereafter be con- proposed, and why such benefit is not avail- ducted in accordance with the Depart- able through use of existing terms defined by regulation. If the claim is intended for a spe- ment’s Uniform Rules of Practice. cific group within the population, the analy- (ii) The hearing shall be conducted sis shall specifically address nutritional before an administrative law judge needs of such group, scientific data sufficient with the opportunity for appeal to the for such purpose, and data and information Department’s Judicial Officer, who to the extent necessary to demonstrate that shall make the final determination for consumers can be expected to understand the meaning of the term under the proposed con- the Secretary. Any such determination ditions of use. by the Secretary shall be conclusive Yours very truly, unless, within 30 days after receipt of Applicant ——————————————— notice of such final determination, the applicant appeals to the United States By ——————————————————— (Indicate authority) Court of Appeals for the circuit in which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL beling application is undergoing Agen- REGISTER a notice informing the public cy review and that the applicant shall subsequently be notified of the Agen- that the synonymous term has been ap- cy’s decision to consider for further re- proved for use. view or deny the labeling application. (m)(1) Labeling applications for the (3) Upon review of the labeling appli- use of an implied nutrient content cation and supporting documentation, claim in a brand name shall be accom- the Agency shall notify the applicant, panied by the following data which in writing, that the labeling applica- shall be submitted in the following tion is either being considered for fur- form to the Director, Food Labeling ther review or that it has been sum- Division, Regulatory Programs, Food marily denied by the Administrator. Safety and Inspection Service, Wash- (4) If the labeling application is sum- ington, DC 20250: marily denied by the Administrator, the written notification shall state the ———————————————————————— reasons therefor, including why the (Date) Agency has determined that the pro- The undersigned, llllll submits this posed synonymous term is false or mis- labeling application pursuant to 9 CFR

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381.469 with respect to (statement of the imposed implied nutrient content claim is plied nutrient content claim and its proposed false or misleading. The notification use in a brand name). letter shall inform the applicant that Attached hereto, in quadruplicate, or on a computer disc copy, and constituting a part the applicant may submit a written of this labeling application, are the follow- statement by way of answer to the no- ing: tification, and that the applicant shall (i) A statement identifying the implied nu- have the right to request a hearing trient content claim, the nutrient the claim with respect to the merits or validity is intended to characterize, the correspond- of the Administrator’s decision to deny ing term for characterizing the level of such the use of the proposed implied nutri- nutrient as defined by a regulation, and the brand name of which the implied claim is in- ent content claim. tended to be a part. The statement shall ad- (i) If the applicant fails to accept the dress why the use of the brand-name as pro- determination of the Administrator posed will not be misleading. The statement and files an answer and requests a shall provide examples of the types of prod- hearing, and the Administrator, after ucts on which the brand name will appear. It review of the answer, determines the shall also include data showing that the ac- initial determination to be correct, the tual level of the nutrient in the food would Administrator shall file with the Hear- qualify the label of the product to bear the corresponding term defined by regulation. ing Clerk of the Department the notifi- Assay methods used to determine the level of cation, answer, and the request for a a nutrient shall meet the requirements stat- hearing, which shall constitute the ed under labeling application format in para- complaint and answer in the proceed- graph (k)(1)(iii) of this section. ing, which shall thereafter be con- (ii) A detailed explanation supported by ducted in accordance with the Depart- any necessary data of why use of the pro- ment’s Uniform Rules of Practice. posed brand name is requested. This explanation shall also state what nutritional ben- (ii) The hearing shall be conducted efit to the public will derive from use of the before an administrative law judge brand name as proposed. If the branded prod- with the opportunity for appeal to the uct is intended for a specific group within Department’s Judicial Officer, who the population, the analysis shall specifi- shall make the final determination for cally address nutritional needs of such group the Secretary. Any such determination and scientific data sufficient for such pur- by the Secretary shall be conclusive pose. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant ——————————————— applicant appeals to the United States By ——————————————————— Court of Appeals for the circuit in (2) Upon receipt of the labeling appli- which the applicant has its principal cation and supporting documentation, place of business or to the United the applicant shall be notified, in writ- States Court of Appeals for the District ing, of the date on which the labeling of Columbia Circuit. application was received. Such notice (5) If the labeling application is not shall inform the applicant that the la- summarily denied by the Adminis- beling application is undergoing Agen- trator, the Administrator shall publish cy review and that the applicant shall a notice of the labeling application in subsequently be notified of the Agen- the FEDERAL REGISTER seeking a com- cy’s decision to consider for further re- ment on the use of the implied nutrient view or deny the labeling application. content claim. The notice shall also (3) Upon review of the labeling appli- summarize the labeling application, in- cation and supporting documentation, cluding where the supporting docu- the Agency shall notify the applicant, mentation can be reviewed. The Ad- in writing, that the labeling applica- ministrator’s notice shall seek com- tion is either being considered for fur- ment from consumers, the industry, ther review or that it has been sum- consumer and industry groups, and marily denied by the Administrator. other interested persons on the label- (4) If the labeling application is sum- ing application and the use of the im- marily denied by the Administrator, plied nutrient content claim. After the written notification shall state the public comment has been received and reasons therefor, including why the reviewed by the Agency, the Adminis- Agency has determined that the pro- trator shall make a determination on

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whether the implied nutrient content content claim has been approved for claim shall be approved for use on the use. labeling of poultry products. (Paperwork requirements were approved by (i) If the claim is denied by the Ad- the Office of Management and Budget under ministrator, the Agency shall notify control number 0583–0088.) the applicant, in writing, of the basis [58 FR 675, Jan. 6, 1993, as amended at 59 FR for the denial, including the reason 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995] why the claim on the labeling was determined by the Agency to be false or §§ 381.470–381.479 [Reserved] misleading. The notification letter shall also inform the applicant that the § 381.480 Label statements relating to usefulness in reducing or maintain- applicant may submit a written state- ing body weight. ment by way of answer to the notification, and that the applicant shall have (a) General requirements. Any product the right to request a hearing with re- that purports to be or is represented spect to the merits or validity of the for special dietary use because of use- Administrator’s decision to deny the fulness in reducing body weight shall use of the proposed implied nutrient bear: content claim. (1) Nutrition labeling in conformity (A) If the applicant fails to accept with § 381.409 of this subpart, unless ex- the determination of the Adminis- empt under that section, and trator and files an answer and requests (2) A conspicuous statement of the a hearing, and the Administrator, after basis upon which the product claims to review of the answer, determines the be of special dietary usefulness. initial determination to be correct, the (b) Nonnutritive ingredients. (1) Any Administrator shall file with the Hear- product subject to paragraph (a) of this ing Clerk of the Department the notifi- section that achieves its special die- cation, answer, and the request for a tary usefulness by use of a nonnutri- hearing, which shall constitute the tive ingredient (i.e., one not utilized in complaint and answer in the proceed- normal metabolism) shall bear on its ing, which shall thereafter be con- label a statement that it contains a ducted in accordance with the Depart- nonnutritive ingredient and the per- ment’s Uniform Rules of Practice. centage by weight of the nonnutritive (B) The hearing shall be conducted ingredient. before an administrative law judge (2) A special dietary product may with the opportunity for appeal to the contain a nonnutritive sweetener or Department’s Judicial Officer, who other ingredient only if the ingredient shall make the final determination for is safe for use in the product under the the Secretary. Any such determination applicable law and regulations of this by the Secretary shall be conclusive chapter. Any product that achieves its unless, within 30 days after receipt of special dietary usefulness in reducing the notice of such final determination, or maintaining body weight through the applicant appeals to the United the use of a nonnutritive sweetener States Court of Appeals for the circuit shall bear on its label the statement in which the applicant has its principal required by paragraph (b)(1) of this sec- place of business or to the United tion, but need not state the percentage States Court of Appeals for the District by weight of the nonnutritive sweet- of Columbia Circuit. ener. If a nutritive sweetener(s) as well (ii) If the claim is approved, the as nonnutritive sweetener(s) is added, Agency shall notify the applicant, in the statement shall indicate the pres- writing, and shall also publish in the ence of both types of sweetener; e.g., FEDERAL REGISTER a notice informing ‘‘Sweetened with nutritive sweetener(s) the public that the implied nutrient and nonnutritive sweetener(s).’’

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(c)‘‘Low calorie’’ foods. A product pur- these products bear no nutrition claims porting to be ‘‘low calorie’’ must com- or nutrition information, ply with the criteria set forth for such (i) A food product, for purposes of the foods in § 381.460. small business exemption, is defined as (d) ‘‘Reduced calorie’’ foods and other a formulation, not including distinct comparative claims. A product purport- flavors which do not significantly alter ing to be ‘‘reduced calorie’’ or other- the nutritional profile, sold in any size wise containing fewer calories than a package in commerce. reference food must comply with the (ii) For purposes of this paragraph, a criteria set forth for such foods in small business is any single-plant facil- § 387.460(b) (4) and (5). ity or multi-plant company/firm that (e) ‘‘Label terms suggesting usefulness employs 500 or fewer people and pro- as low calorie or reduced calorie foods’’. duces no more than the following (1) Except as provided in paragraphs amounts of pounds of the product (e)(2) and (e)(3) of this section, a prod- qualifying the firm for exemption from uct may be labeled with terms such as this subpart: ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- (A) During the first year of imple- ened,’’ or ‘‘sweetened with nonnutri- mentation of nutrition labeling, from tive sweetener’’ only if the claim is not July 1994 to July 1995, 250,000 pounds or false or misleading, and the product is less, labeled ‘‘low calorie’’ or ‘‘reduced cal- (B) During the second year of imple- orie’’ or bears another comparative cal- mentation of nutrition labeling, from orie claim in compliance with the ap- July 1995 to July 1996, 175,000 pounds or plicable provisions in this subpart. less, and (2) Paragraph (e)(1) of this section (C) During the third year of imple- shall not apply to any use of such mentation and subsequent years there- terms that is specifically authorized by after, 100,000 pounds or less. regulation governing a particular food, (iii) For purposes of this paragraph, or, unless otherwise restricted by regu- calculation of the amount of pounds lation, to any use of the term ‘‘diet’’ shall be based on the most recent 2- that clearly shows that the product is year average of business activity. offered solely for a dietary use other Where firms have been in business less than regulating body weight, e.g., ‘‘for than 2 years or where products have low sodium diets.’’ been produced for less than 2 years, reasonable estimates must indicate (3) Paragraph (e)(1) of this section that the annual pounds produced will shall not apply to any use of such not exceed the amounts specified. terms on a formulated meal replace- (2) Products intended for further ment or other product that is rep- processing, provided that the labels for resented to be of special dietary use as these products bear no nutrition claims a whole meal, pending the issuance of a or nutrition information, regulation governing the use of such (3) Products that are not for sale to terms on foods. consumers, provided that the labels for (f) ‘‘Sugar free’’ and ‘‘no added these products bear no nutrition claims sugar’’. Criteria for the use of the or nutrition information, terms ‘‘sugar free’’ and ‘‘no added (4) Products in small packages that sugar’’ are provided for in § 381.460(c). are individually wrapped packages of [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, less than 1⁄2 ounce net weight, provided 1993, as amended at 58 FR 47628, Sept. 10, that the labels for these products bear 1993; 60 FR 217, Jan. 3, 1995] no nutrition claims or nutrition information, §§ 381.481–381.499 [Reserved] (5) Products custom slaughtered or prepared, § 381.500 Exemption from nutrition la- (6) Products intended for export, and beling. (7) The following products prepared (a) The following poultry products and served or sold at retail provided are exempt from nutrition labeling: that the labels or the labeling of these (1) Food products produced by small products bear no nutrition claims or businesses, provided that the labels for nutrition information:

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(i) Ready-to-eat products that are shall be listed immediately below the packaged or portioned at a retail store heading ‘‘Percent Daily Value’’; and or similar retail-type establishment; (v) Such labeling shall not include and the footnote specified in § 381.409(d)(9). (ii) Multi-ingredient products (e.g. (d)(1) Products in packages that have sausage) processed at a retail store or a total surface area available to bear similar retail-type establishment. labeling of less than 12 square inches (b) Restaurant menus generally do are exempt from nutrition labeling, not constitute labeling or fall within provided that the labeling for these the scope of these regulations. (c)(1) Foods represented to be specifi- products bear no nutrition claims or cally for infants and children less than other nutrition information. The man- 2 years of age shall bear nutrition la- ufacturer, packer, or distributor shall beling as provided in paragraph (c)(2) of provide, on the label of packages that this section, except such labeling shall qualify for and use this exemption, an not include calories from fat, calories address or telephone number that a from saturated fat, saturated fat, ste- consumer can use to obtain the re- aric acid, polyunsaturated fat, quired nutrition information (e.g., monounsaturated fat, and cholesterol. ‘‘For nutrition information call 1–800– (2) Foods represented or purported to 123–4567’’). be specifically for infants and children (2) When such products bear nutri- less than 4 years of age shall bear nu- tion labeling, either voluntarily or be- trition labeling except that: cause nutrition claims or other nutri- (i) Such labeling shall not include tion information is provided, all re- declarations of percent of Daily Value quired information shall be in a type for total fat, saturated fat, cholesterol, size no smaller than 6 point or all sodium, potassium, total carbohydrate, 1 upper case type of /16-inch minimum and dietary fiber; height, except that individual serving- (ii) Nutrient names and quantitative size packages of poultry products that amounts by weight shall be presented have a total area available to bear la- in two separate columns; beling of 3 square inches or less may (iii) The heading ‘‘Percent Daily provide all required information in a Value’’ required in § 381.409(d)(6) shall 1 be placed immediately below the quan- type size no smaller than /32-inch mini- titative information by weight for pro- mum height. tein; [58 FR 675, Jan. 6, 1993, as amended at 58 FR (iv) The percent of the Daily Value 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; for protein, vitamins, and minerals 60 FR 217, Jan. 3, 1995]

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